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Title: Systematic review of the impact of acellular dermal matrix on aesthetics and patient satisfaction in tissue expander-to-implant breast reconstructions [Literature Search Files] Open Access Deposited

http://creativecommons.org/licenses/by/4.0/
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  • The data in this work originate from the literature searches of several citation databases, including MEDLINE (Ovid), Embase (Elsevier), CINAHL (EBSCOhost), and Cochrane Central Register of Controlled Trials (Wiley).
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  • The dataset includes all citations considered for inclusion in the systematic review. The citations are accessible in Endnote (enlx), as well as through the primary citation export files from each database. The literature search strategies are included for reproducibility and transparency purposes. See the published methods for more information.
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  • markmac@umich.edu
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  • DeLong MR, Tandon VJ, Farajzadeh M, Berlin NL, MacEachern MP, Rudkin GH, Da Lio AL, Cederna PS. (2019). Systematic review of the impact of acellular dermal matrix on aesthetics and patient satisfaction in tissue expander-to-implant breast reconstructions. Plastic and Reconstructive Surgery.
  • https://doi.org/10.1097/PRS.0000000000006212
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  • 04/27/2020
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  • 10/25/2019
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  • https://doi.org/10.7302/75eh-5s19
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To Cite this Work:
DeLong, M., Tandon, V., Farajzadeh, M., Berlin, N., MacEachern, M., Rudkin, G., Da Lio, A., Cederna, P. (2019). Systematic review of the impact of acellular dermal matrix on aesthetics and patient satisfaction in tissue expander-to-implant breast reconstructions [Literature Search Files] [Data set]. University of Michigan - Deep Blue. https://doi.org/10.7302/75eh-5s19

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Record #1 of 37
ID: CN-00921049
AU: Lynch MP
AU: Chung MT
AU: Rinker BD
TI: Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction: a prospective comparative study
SO: Journal of plastic, reconstructive & aesthetic surgery
YR: 2013
VL: 66
NO: 11
PG: 1534-1542
PM: PUBMED 23871569
PT: Comparative Study; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
KY: Abdomen [surgery];Acellular Dermis [adverse effects];Cicatrix [etiology];Health Care Costs;Mammaplasty [adverse effects] [economics] [methods];Microvessels;Operative Time;Patient Satisfaction;Prospective Studies;Skin [blood supply];Skin Transplantation [adverse effects];Tissue Expansion [adverse effects] [economics] [methods];Transplant Donor Site [surgery];Wound Healing;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-WOUNDS
DOI: 10.1016/j.bjps.2013.07.002
AB: The use of acellular dermal matrix (ADM) in tissue expander breast reconstruction has several advantages but increased complications have been reported. Dermal autografts may offer a safer and more cost-effective alternative. The purpose of this prospective study was to compare the outcomes of tissue expander breast reconstruction using dermal autografts with ADM-assisted reconstruction. Patients undergoing tissue expander breast reconstruction with either ADM or dermal autografts were enrolled. Autografts were harvested from the lower abdomen. At each follow-up visit, patients were surveyed on a seven-point scale for scar and overall satisfaction. Biopsies taken at the time of device exchange were evaluated histologically with CD34 staining to assess tissue integration and vessel ingrowth. Expansion parameters, complications, procedural costs, and operative times were compared. Forty-eight patients were enrolled (76 breasts). Twenty-seven patients received ADM, and twenty-one patients received dermal autograft. Wound healing complications were significantly higher in the ADM group (14.8% versus 4.8%, p-value = 0.03), as were major complications (18.5% versus 0%, p-value < 0.01). Histologic vessel counts in the autograft group averaged 21 vessels/mm(2), compared to 7 vessels/mm(2) in the ADM group (p-value < 0.01). There was no difference between the two groups in scar satisfaction or overall satisfaction. Patients receiving dermal autograft had a lower incidence of major complications and delayed wound healing than patients who received ADM. Despite harvest time, the overall cost of the ADM-assisted expander placement was higher. Dermal autograft-assisted breast reconstruction offers many of the benefits of ADM, but with a lower cost and improved safety profile.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/049/CN-00921049/frame.html

Record #2 of 37
ID: CN-01340949
AU: Dikmans RE
AU: Negenborn VL
AU: Bouman MB
AU: Winters HA
AU: Twisk JW
AU: Ruhé PQ
AU: Mureau MA
AU: Smit JM
AU: Tuinder S
AU: Eltahir Y
AU: Posch NA
AU: Steveninck-Barends JM
AU: Meesters-Caberg MA
AU: Hulst RR
AU: Ritt MJ
AU: Mullender MG
TI: Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial
SO: The lancet. Oncology
YR: 2017
VL: 18
NO: 2
PG: 251-258
PM: PUBMED 28012977
XR: EMBASE 614221770
PT: Clinical Trial, Phase IV; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Acellular Dermis [utilization];Breast Implantation [methods];Breast Implants;Breast Neoplasms [pathology] [surgery];Carcinoma, Ductal, Breast [pathology] [surgery];Carcinoma, Intraductal, Noninfiltrating [pathology] [surgery];Carcinoma, Lobular [pathology] [surgery];Follow-Up Studies;Mammaplasty [methods];Mastectomy [methods];Neoplasm Staging;Netherlands;Postoperative Complications;Prospective Studies;Quality of Life;Reoperation;Research Design;Treatment Outcome;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];*acellular dermal matrix; adult; adverse outcome; article; breast carcinoma/su [Surgery]; breast implant; *breast reconstruction; controlled study; device removal; disease severity; female; gene mutation; genetic linkage; high risk patient; human; intermethod comparison; major clinical study; mastectomy; multicenter study; Netherlands; *one stage implant based breast reconstruction; open study; patient safety; patient satisfaction; phase 4 clinical trial; postoperative complication/co [Complication]; prospective study; quality of life; randomized controlled trial; reoperation; risk factor; skin necrosis/co [Complication]; surgical mesh; *two stage implant based breast reconstruction; wound dehiscence/co [Complication]; wound infection/co [Complication]; BRCA1 protein/ec [Endogenous Compound]; BRCA2 protein/ec [Endogenous Compound]; adverse drug reaction; breast cancer; breast carcinoma; clinical trial; controlled clinical trial; doctor patient relation; funding; logistic regression analysis; nut; odds ratio; peroperative complication; randomization; safety; side effect; surgery; *surgical mesh; young adult
DOI: 10.1016/S1470-2045(16)30668-4
AB: METHODS: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446.FINDINGS: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups.INTERPRETATION: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved.FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.BACKGROUND: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/949/CN-01340949/frame.html

Record #3 of 37
ID: CN-01076818
AU: Mendenhall SD
AU: Anderson LA
AU: Ying J
AU: Boucher KM
AU: Liu T
AU: Neumayer LA
AU: Agarwal JP
TI: The BREASTrial: stage I. Outcomes from the time of tissue expander and acellular dermal matrix placement to definitive reconstruction
SO: Plastic and reconstructive surgery
YR: 2015
VL: 135
NO: 1
PG: 29e-42e
PM: PUBMED 25539349
PT: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Acellular Dermis;Collagen;Mammaplasty [methods];Mastectomy;Skin, Artificial;Tissue Expansion;Treatment Outcome;Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0000000000000758
AB: METHODSA randomized trial was conducted to analyze outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of obesity, radiation, and chemotherapy on complications and biointegration of matrix was investigated. The trial was divided into three stages, with stage I results reported here.RESULTSOne hundred twenty-eight patients (199 breasts) were randomized equally over 2.5 years. Most patients were white, healthy nonsmokers. The overall complication rate was 36.2 percent; half of the complications were minor. The AlloDerm and DermaMatrix groups had similar rates of complications (33.6 percent versus 38.8 percent; p = 0.52), consisting mostly of skin necrosis (17.8 percent versus 21.4 percent; p = 0.66) and infections (13.9 percent versus 16.3 percent; p = 0.29), both of which led to tissue expander losses (5 percent versus 11.2 percent; p = 0.11). The AlloDerm group required less time for completion of expansion (42 days versus 70 days; p < 0.001). Obesity was associated with poor matrix biointegration and a longer drain time, both of which were associated with higher complication rates.CONCLUSIONThe Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial is the largest randomized trial to date in matrix breast reconstruction and emphasizes the importance of careful patient and allograft selection to minimize complications.CLINICAL QUESTION/LEVEL OF EVIDENCETherapeutic, II.BACKGROUNDUse of acellular dermal matrix in tissue expander breast reconstruction has become a popular adjunct to the total submuscular technique. The question remains as to which matrix, if any, is ideal for breast reconstruction.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/818/CN-01076818/frame.html

Record #4 of 37
ID: CN-01120691
AU: Zhong T
AU: Temple-Oberle C
AU: Hofer SO
AU: Hofer S
AU: Beber B
AU: Semple J
AU: Brown M
AU: Macadam S
AU: Lennox P
AU: Panzarella T
AU: McCarthy C
AU: Baxter N
TI: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction
SO: Trials
YR: 2013
VL: 14
PG: 356
PM: PUBMED 24165392
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Acellular Dermis [economics];Breast Implantation [adverse effects] [economics] [instrumentation];Breast Implants [economics];Breast Neoplasms [economics] [pathology] [surgery];Canada;Clinical Protocols;Cost-Benefit Analysis;Health Care Costs;Mastectomy;Neoplasm Staging;Patient Satisfaction;Prosthesis Design;Quality of Life;Quality-Adjusted Life Years;Research Design;Surveys and Questionnaires;Time Factors;Tissue Expansion Devices;Treatment Outcome;Female[checkword];Humans[checkword]
DOI: 10.1186/1745-6215-14-356
AB: METHODS/DESIGNS: The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.DISCUSSION: There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.TRIAL REGISTRATION: ClinicalTrials.gov: NCT00956384.BACKGROUND: The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/691/CN-01120691/frame.html

Record #5 of 37
ID: CN-01076819
AU: Agarwal JP
AU: Mendenhall SD
AU: Anderson LA
AU: Ying J
AU: Boucher KM
AU: Liu T
AU: Neumayer LA
TI: The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial
SO: Plastic and reconstructive surgery
YR: 2015
VL: 135
NO: 1
PG: 20e-8e
PM: PUBMED 25539330
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Acellular Dermis;Adolescent;Breast Neoplasms [surgery];Mammaplasty [methods];Prospective Studies;Randomized Controlled Trials as Topic [methods];Research Design;Single-Blind Method;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
DOI: 10.1097/PRS.0000000000000809
AB: METHODSA prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications.RESULTSThis article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education.CONCLUSIONResults from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction.CLINICAL QUESTION/LEVEL OF EVIDENCETherapeutic, II.BACKGROUNDRecent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/819/CN-01076819/frame.html

Record #6 of 37
ID: CN-01164292
AU: Gabriel A
AU: Champaneria MC
AU: Maxwell GP
TI: The efficacy of botulinum toxin A in post-mastectomy breast reconstruction: a pilot study
SO: Aesthetic surgery journal
YR: 2015
VL: 35
NO: 4
PG: 402-409
PM: PUBMED 25825421
XR: EMBASE 20160062569
PT: Journal Article; Randomized Controlled Trial
KY: Acellular Dermis;Botulinum Toxins, Type A [administration & dosage];Breast Neoplasms [surgery];Follow-Up Studies;Mammaplasty [methods];Mastectomy [methods];Neuromuscular Agents [administration & dosage];Pain Measurement;Pain, Postoperative [prevention & control];Pilot Projects;Prospective Studies;Tissue Expansion [methods];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];acellular dermal matrix; adult; *analgesia; article; *breast reconstruction; breast tissue expander; clinical article; controlled study; *drug efficacy; female; follow up; hematoma/co [Complication]; human; incidence; infection/co [Complication]; *mastectomy; outcome assessment; pain assessment; pain severity; pectoralis major muscle; pilot study; *postoperative pain/dt [Drug Therapy]; priority journal; seroma/co [Complication]; skin necrosis/co [Complication]; tissue expansion; visual analog scale; *botulinum toxin A/dt [Drug Therapy]; *botulinum toxin A/pd [Pharmacology]; narcotic agent; placebo
DOI: 10.1093/asj/sjv040
AB: Background: Botulinum toxin A has been successfully used in a variety of areas to temporarily obliterate muscle mobility for either functional or aesthetic gain. Tissue expander-based breast reconstruction has been plagued with pain and discomfort. Objective: The purpose of this pilot study was to evaluate the role of a neurotoxin (Botulinum toxin A) in expander-based breast reconstruction. Methods: Thirty patients underwent mastectomies with immediate expander or acellular dermal matrix reconstruction. The neurotoxin group (n = 15) received 40 units of neurotoxin (Botulinum toxin A, Allergan, Inc, Irvine, CA) into each pectoralis major muscle through 4 serial injections and the placebo group (n = 15) received 4 serial injections of 0.9% NaCl. All patients were followed over 1 year, and patient demographics, VAS (visual analog score), laterality, office visits, amount of expansion and number of times to full expansion, and amount of narcotics required were recorded. Statistical significance was considered as p < .05. Results: There were no significant differences between the two groups in terms of age, laterality, expander size, or complications (p = .46-.66). There was a significant difference between the two groups in the VAS score, demonstrating decreased pain in the neurotoxin group (p < .05). In addition, there was a significant increase in the volume of expansion per visit in the neurotoxin group as compared to the placebo group (p < .05). There was no significant difference in narcotic use in the first 3 days after surgery; however, there was a significant decrease in use of narcotics from 7 to 45 days in the neurotoxin group (p < .05). There were no complications associated with the use of the neurotoxin. Conclusions: The infiltration of the pectoralis major muscle with neurotoxin in immediate, expander-based reconstruction may be beneficial in reducing pain and expediting expansions.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/292/CN-01164292/frame.html

Record #7 of 37
ID: CN-01139384
AU: Cook L
AU: Douek M
TI: Outcomes of immediate breast reconstruction using an implant and acellular dermal matrix: a systematic review of the different products currently in use
SO: European journal of surgical oncology.
YR: 2015
VL: 41
NO: 6
PG: S52
XR: EMBASE 72214362
PT: Journal: Conference Abstract
KY: *breast reconstruction; *implant; *acellular dermal matrix; *systematic review; *breast surgery; human; surgical mesh; risk; cohort analysis; nonhuman; control group; dermis; data base; case study; randomized controlled trial; breast; meta analysis; checklist; metformin
DOI: 10.1016/j.ejso.2015.03.130
AB: Introduction: Over the last 10-15 years there has been a significant increase in acellular dermal matrix (ADM) use for breast reconstruction, which has lead to the introduction of multiple alternative ADM products. We conducted a systematic review of studies reporting on the outcomes of ADMs currently used for immediate implant-based breast reconstruction. Methods: Ovid SP versions of EMBASE and MEDLINE databases were used. Search terms were: (("breast" OR "breast reconstruction") AND ("acellular dermal matrix" OR "acellular dermis" OR Strattice OR Surgimend OR Alloderm OR Human acellular dermis OR cadaveric dermis or acellular dermis-assisted or Dermamatrix or FlexHD or Neoform)). Strict inclusion and exclusion criteria were applied, data was abstracted using a pro forma and risk of bias was assessed using the Down's and Black checklist. Results: A total of 27 studies met inclusion criteria. 18/27 were retrospective case series and 9/27 were cohort studies with a non-ADM control group. There were no randomised controlled trials. There were 2 studies on bovine ADM use and 6 on porcine ADM use, with the remainder reporting on human ADMs. Significant risk of bias was demonstrated in the cohort studies, mainly as a result of allocation bias and a lack of information related to the distribution of potential confounders. Conclusions: There remains very little high quality evidence for the outcomes of breast reconstruction using an ADM, particularly for non-human ADMs. High risk of bias means individual study results cannot reliably be combined in the form of a meta-analysis.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/384/CN-01139384/frame.html

Record #8 of 37
ID: CN-00864468
AU: McCarthy CM
AU: Lee CN
AU: Halvorson EG
AU: Riedel E
AU: Pusic AL
AU: Mehrara BJ
AU: Disa JJ
TI: The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial
SO: Plastic and reconstructive surgery
YR: 2012
VL: 130
NO: 5 Suppl 2
PG: 57S-66S
PM: PUBMED 23096987
PT: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Acellular Dermis;Analgesia, Patient-Controlled;Antineoplastic Agents [administration & dosage] [therapeutic use];Breast Implantation [methods];Breast Neoplasms [drug therapy] [surgery];Chemotherapy, Adjuvant;Collagen [therapeutic use];Combined Modality Therapy;Esthetics;Implant Capsular Contracture [epidemiology];Mammaplasty [methods] [psychology];Mastectomy;Narcotics [administration & dosage] [therapeutic use];Pain Measurement;Pain, Postoperative [drug therapy] [epidemiology] [prevention & control];Patient Satisfaction;Quality of Life;Single-Blind Method;Time Factors;Tissue Expansion Devices;Treatment Outcome;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0b013e31825f05b4
AB: METHODS: The randomized controlled trial was conducted at two U.S. centers from 2008 to 2011. Immediately following mastectomy, all patients were randomized to one of two treatment arms: (1) acellular dermal matrix-assisted, tissue expander/implant reconstruction; and (2) submuscular tissue expander/implant placement. All patients were blinded to their treatment arm.RESULTS: One hundred eight consented to participate; 38 were excluded prior to randomization. In total, 70 patients were randomized. There were no differences seen in immediate postoperative pain (p = 0.19) or pain during the expansion phase (p = 0.65) between treatment arms. There was similarly no difference in postoperative narcotic use (p = 0.38). The rate of postoperative expansion did not differ between groups (p = 0.83).CONCLUSIONS: The results suggest that the use of acellular dermal matrix in the setting of tissue expander/implant reconstruction neither reduces postoperative pain nor accelerates the rate of postoperative expansion. An examination of its efficacy in improving long-term outcomes following tissue expander/implant reconstruction is warranted.BACKGROUND: Current efficacy data supporting the routine use of acellular dermal matrices in postmastectomy tissue expander/implant reconstruction are limited. A multicenter, blinded, randomized controlled study was designed to evaluate the effectiveness of acellular dermal matrix in the setting of tissue expander/implant reconstruction. The primary objective of the study was to determine whether the use of matrix would decrease patient-reported postoperative pain. The secondary objective was to determine whether its use would accelerate the rate of postoperative expansion.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/468/CN-00864468/frame.html

Record #9 of 37
ID: CN-01153920
AU: Gschwantler-Kaulich D
AU: Schrenk P
AU: Bjelic-Radisic V
AU: Unterrieder K
AU: Leser C
AU: Fink-Retter A
AU: Salama M
AU: Singer C
TI: Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial
SO: European journal of surgical oncology
YR: 2016
VL: 42
NO: 5
PG: 665-671
PM: PUBMED 26947961
XR: EMBASE 20160186255
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Acellular Dermis [utilization];Austria;Breast Implants;Esthetics;Mammaplasty [instrumentation] [methods];Patient Satisfaction;Pilot Projects;Postoperative Complications;Prospective Studies;Quality of Life;Surgical Mesh;Surveys and Questionnaires;Female[checkword];Humans[checkword];Middle Aged[checkword];*acellular dermal matrix; adult; article; breast cancer/su [Surgery]; *breast reconstruction; clinical article; female; hematoma/co [Complication]; human; *implant based breast reconstruction; infection/co [Complication]; intermethod comparison; mastectomy; multicenter study; patient satisfaction; pilot study; priority journal; prospective study; quality of life; randomized controlled trial; seroma/co [Complication]; *surgical mesh; *titanized mesh; wound healing/co [Complication]
DOI: 10.1016/j.ejso.2016.02.007
AB: Background Comparative studies on the use of meshes and acellular dermal matrices (ADM) in implant-based breast reconstruction (IBBR) have not yet been performed. Methods This prospective, randomized, controlled, multicenter pilot study was performed at four Austrian breast cancer centers. Fifty patients with oncologic or prophylactic indication for mastectomy and IBBR were randomized to immediate IBBR with either an ADM (Protexa) or a titanized mesh (TiLOOP Bra). Complications, failed reconstruction, cosmetic outcome, patients' quality of life and the thickness of the overlying tissue were recorded immediately postoperatively and 3 and 6 months after surgery. Results 48 patients participated in the study (Protexa group: 23; TiLOOP Bra group: 25 patients). The overall complication rate was 31.25% with similar rates in both groups (Protexa group: 9 versus TiLOOP Bra group: 6; p = 0.188). There was a higher incidence of severe complications leading to failed reconstructions with implant loss in the Protexa group than in the TiLOOP Bra group (7 versus 2; p < 0.0001). An inverted T-incision technique led to significantly more complications and reconstructive failure with Protexa (p = 0.037, p = 0.012, respectively). There were no significant differences in patients' satisfaction with cosmetic results (p = 0.632), but surgeons and external specialists graded significantly better outcomes with TiLOOP Bra (p = 0.034, p = 0.032). Conclusion This pilot study showed use of TiLOOP Bra or Protexa in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. To validate the higher failure rates in the Protexa group, data from a larger trial are required. NCT02562170
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/920/CN-01153920/frame.html

Record #10 of 37
ID: CN-00770927
AU: Basu CB
AU: Leong M
AU: Hicks MJ
TI: Acellular cadaveric dermis decreases the inflammatory response in capsule formation in reconstructive breast surgery
SO: Plastic and reconstructive surgery
YR: 2010
VL: 126
NO: 6
PG: 1842-1847
PM: PUBMED 21124125
PT: Controlled Clinical Trial; Journal Article
KY: Biopsy;Breast [pathology];Breast Implantation [methods];Breast Neoplasms [surgery];Case-Control Studies;Collagen;Fibrosis [pathology] [prevention & control];Foreign-Body Reaction [pathology] [prevention & control];Postoperative Complications [pathology] [prevention & control];Reoperation [methods];Tissue Expansion [methods];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0b013e3181f44674
AB: METHODSTwenty patients underwent tissue expander reconstruction using the "dual-plane" acellular cadaveric dermis technique (AlloDerm). During implant exchange, intraoperative biopsy specimens were obtained of (1) biointegrated acellular cadaveric dermis and (2) native subpectoral capsule (internal control). Histopathologic analysis was performed. Masked biopsy specimens were scored semiquantitatively by an experienced histopathologist to reflect observed granulation tissue formation, vessel proliferation, chronic inflammatory changes, capsule fibrosis, fibroblast cellularity, and foreign body giant cell inflammatory reaction. Scores were analyzed statistically using the Wilcoxon signed rank test.RESULTSAcellular cadaveric dermis (AlloDerm) had statistically diminished levels for all parameters compared with corresponding native breast capsules (p<0.001).CONCLUSIONSThis represents the first detailed histopathologic comparative analysis between biointegrated acellular cadaveric dermis and native capsules in implant-based breast reconstruction. These histopathologic findings suggest that certain properties intrinsic to acellular cadaveric dermis may limit capsule formation by diminishing inflammatory changes that initiate capsule formation. Further investigation is needed to determine whether acellular cadaveric dermis reduces the incidence of breast capsular contracture.BACKGROUNDAcellular cadaveric dermis in implant-based breast reconstruction provides an alternative to total submuscular placement. To date, there has been no detailed in vivo human analysis of the histopathologic sequelae of acellular cadaveric dermis in implant-based breast reconstruction. Based on clinical observations, we hypothesize that acellular cadaveric dermis decreases the inflammatory response and foreign body reaction normally seen around breast implants.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/927/CN-00770927/frame.html

Record #11 of 37
ID: CN-01368224
AU: Hinchcliff KM
AU: Orbay H
AU: Busse BK
AU: Charvet H
AU: Kaur M
AU: Sahar DE
TI: Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: a prospective randomized trial
SO: Journal of plastic, reconstructive & aesthetic surgery
YR: 2017
VL: 70
NO: 5
PG: 568-576
PM: PUBMED 28341592
PT: Comparative Study; Journal Article; Randomized Controlled Trial
KY: Acellular Dermis;Breast Implants;Collagen [economics] [therapeutic use];Cost-Benefit Analysis;Mammaplasty [adverse effects] [economics] [methods];Patient Satisfaction;Postoperative Complications [etiology];Prospective Studies;Tissue Expansion [adverse effects] [education] [instrumentation];Tissue Expansion Devices [adverse effects] [economics];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1016/j.bjps.2017.02.024
AB: AlloDerm RTU
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/224/CN-01368224/frame.html

Record #12 of 37
ID: CN-00876300
AU: Dieterich M
AU: Paepke S
AU: Zwiefel K
AU: Dieterich H
AU: Blohmer J
AU: Faridi A
AU: Klein E
AU: Gerber B
AU: Nestle-Kraemling C
TI: Implant-based breast reconstruction using a titanium-coated polypropylene mesh (TiLOOP Bra): a multicenter study of 231 cases
SO: Plastic and reconstructive surgery
YR: 2013
VL: 132
NO: 1
PG: 8e-19e
PM: PUBMED 23806958
PT: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Breast Implants;Breast Neoplasms [surgery];Coated Materials, Biocompatible;Follow-Up Studies;Germany [epidemiology];Incidence;Mammaplasty [methods];Mastectomy;Patient Satisfaction;Polypropylenes;Postoperative Complications [epidemiology];Prognosis;Retrospective Studies;Risk Factors;Surgical Mesh;Time Factors;Titanium;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
DOI: 10.1097/PRS.0b013e318290f8a0
AB: METHODSTwo hundred seven patients (231 breasts) with skin-sparing/nipple-sparing or modified radical mastectomy and immediate or delayed implant-based breast reconstruction using titanium-coated polypropylene mesh were evaluated retrospectively. The primary endpoints were identification of patient-related and surgical factors that were predictive for an adverse outcome and the development of recommendations for patients eligible for implant-based breast reconstruction using the mesh. Complications were divided into major (need for additional surgery), minor (conservative treatment), and implant loss. Univariate and multivariate logistic regression analyses were performed to determine the influence of the patient- and procedure-related characteristics on postoperative complications and implant loss.RESULTSNo risk factors were observed for patient-associated complications. Major complications occurred in 13.4 percent, minor complications in 15.6 percent, and implant loss in 8.7 percent of patients. Univariate analysis revealed procedure-related risk factors for postoperative complications with a bilateral procedure (p = 0.013) or skin expansion before implant surgery (p = 0.043). Multivariate analysis confirmed these risk factors and revealed an increased risk for implant loss in patients with skin necrosis (p < 0.001) and capsule fibrosis (p < 0.001).CONCLUSIONSThis titanium-coated polypropylene mesh shows acceptable complication rates and can be a helpful device in implant-based breast reconstruction. The mesh should only be used in primary cases and, when adhering to the proposed indications, is a safe and convenient option in implant-based breast reconstruction.CLINICAL QUESTION/LEVEL OF EVIDENCERisk, III.BACKGROUNDAn alternative to implant-based breast reconstruction using acellular dermal matrix is the use of a titanium-coated polypropylene mesh. The mesh was approved for implant-based breast reconstruction in Europe in 2008, but only limited clinical data are available.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/300/CN-00876300/frame.html

Record #13 of 37
ID: CN-00910455
AU: Wu C
AU: Cipriano J
AU: Osgood Jr G
AU: Tepper D
AU: Siddiqui A
TI: Human acellular dermal matrix (AlloDerm) dimensional changes and stretching in tissue expander/implant breast reconstruction
SO: Journal of plastic, reconstructive and aesthetic surgery
YR: 2013
VL: 66
NO: 10
PG: 1376-1381
PM: PUBMED 23790562
XR: EMBASE 52640565
PT: Journal: Article
KY: *acellular dermal matrix; adult; antibiotic therapy; article; aspiration; blood vessel clip; *breast implant; Breast Q questionnaire; *breast reconstruction; *breast tissue expander; case study; cellulitis/co [Complication]; cellulitis/dt [Drug Therapy]; cohort analysis; controlled clinical trial; controlled study; debridement; echography; endoleak/co [Complication]; erythema/co [Complication]; female; follow up; human; *human acellular dermal matrix; major clinical study; mastectomy; *muscle stretching; open study; patient satisfaction; perimeter; postoperative complication/co [Complication]; priority journal; red breast syndrome/dt [Drug Therapy]; seroma/co [Complication]; seroma/th [Therapy]; skin disease/dt [Drug Therapy]; skin necrosis/co [Complication]; skin necrosis/su [Surgery]; structured questionnaire; surgical patient; urinary tract infection/co [Complication]; urinary tract infection/dt [Drug Therapy]; wound healing impairment/co [Complication]; antibiotic agent/dt [Drug Therapy]; cefalexin/cb [Drug Combination]; cefalexin/dt [Drug Therapy]; cefalexin/po [Oral Drug Administration]; ciprofloxacin/dt [Drug Therapy]; ciprofloxacin/po [Oral Drug Administration]; prednisone/cb [Drug Combination]; prednisone/dt [Drug Therapy]; prednisone/po [Oral Drug Administration]; breast; cellulitis; explant; *human; patient; procedures; questionnaire; satisfaction; seroma; skin necrosis; *stretching; *tissue expansion; *tissues; ultrasound; urinary tract infection; wound healing impairment
DOI: 10.1016/j.bjps.2013.05.018
AB: Background Human acellular dermal matrix (HADM) is widely used for post-mastectomy tissue expander/implant breast reconstruction. Since HADM has been shown to stretch following placement in other surgical settings, we hypothesised that stretching would occur in breast reconstruction as well. The goal of the study was to quantify the in situ stretch properties of HADM over time in patients undergoing this procedure. Methods This was an open-label, prospective case series in adult women who underwent post-mastectomy tissue expander/implant breast reconstruction using HADM. HADM construct size was determined at postoperative day 1 and month 3 via ultrasound tracking of metallic 3-mm vessel clips embedded in the graft. Dimensional changes were further examined in four equally sized segments (medial, lateral and two central) of the matrix. Patient satisfaction was evaluated at month 3 (a modified version of the Breast QTM patient questionnaire) and compared with satisfaction reported by a non-HADM reconstruction cohort. Results A total of 31 patients underwent breast reconstruction with HADM. Mean (standard deviation) perimeter increased from 38 (6) cm on postoperative day 1-42 (7) cm at month 3 (+11%; P = 0.002). Surface area increased from 73 (22) to 88 (28) cm2 (+21%; range, 4-35%; P = 0.002). The greatest expansion occurred in the HADM medial and lateral segments (range, 18-30% across the four segments). Patient satisfaction was comparable with that of non-HADM patients. Complications in the HADM group included late seroma, red breast syndrome and urinary tract infection. Complications in the non-HADM cohort included cellulitis, expander explantation, delayed wound healing and skin necrosis. Conclusions During short-term follow-up, HADM exhibited a modest degree of stretching during tissue expander/implant breast reconstruction and was associated with few complications and a high level of patient satisfaction. © 2013 Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Surgeon.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/455/CN-00910455/frame.html

Record #14 of 37
ID: CN-00915067
AU: Zhong T
AU: Temple-Oberle C
AU: Hofer S
AU: Beber B
AU: Semple J
AU: Brown M
AU: Macadam S
AU: Lennox P
AU: Panzarella T
AU: McCarthy C
AU: Baxter N
AU: Butler C
AU: Causarano N
AU: Choi J
AU: Webb C
TI: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction
SO: Trials
YR: 2013
VL: 14
NO: 1
PM: PUBMED 24165392
XR: EMBASE 52841851
PT: Journal: Article
KY: *acellular dermal matrix; adult; antibiotic therapy; article; *breast cancer/su [Surgery]; *breast implant; BREAST Q; *breast reconstruction; *breast tissue expander; Canada; cancer patient; clinical protocol; cohort analysis; controlled study; cost effectiveness analysis; disease severity; female; human; long term care; major clinical study; multicenter study; *nipple sparing mastectomy; outcome assessment; *partial mastectomy; patient satisfaction; patient selection; photography; postoperative complication; postoperative infection/co [Complication]; postoperative infection/dt [Drug Therapy]; quality of life; randomized controlled trial; rating scale; *silicone breast implant; single blind procedure; *skin sparing mastectomy; surgical technique; treatment planning; antibiotic agent/dt [Drug Therapy]; arm; breast; case study; gold standard; *human; *implant; mastectomy; nipple; North America; patient; planning; population; procedures; randomization; *randomized controlled trial; registration; skin; surgeon; *tissue expander; tissues
DOI: 10.1186/1745-6215-14-356
AB: Background: The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.Methods/designs: The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.Discussion: There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.Trial registration: ClinicalTrials.gov: NCT00956384. © 2013 Zhong et al.; licensee BioMed Central Ltd.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/067/CN-00915067/frame.html

Record #15 of 37
ID: CN-01139314
AU: Dikmans R
AU: Negenborn V
AU: Bouman MB
AU: Hay W
AU: Twisk J
AU: Ruhe Q
AU: Mureau M
AU: Smit JM
AU: Tuinder S
AU: Eltahir Y
AU: Posch N
AU: Meesters-Caberg M
AU: Ritt M
AU: Mullender M
TI: Two-stage implant-based breast reconstruction is safer than immediate one-stage implant-based breast reconstruction augmented with an a cellular dermal matrix: a multicentre randomized controlled trial
SO: European journal of cancer.
YR: 2016
VL: 57
PG: S3
XR: EMBASE 72220505
PT: Journal: Conference Abstract
KY: *breast reconstruction; *implant; *human; *breast cancer; *randomized controlled trial; *European; patient; procedures; Netherlands; breast; register; explant; statistical model; logistic regression analysis; hospital; adverse outcome; safety; quality of life; tissue reaction; postoperative complication; mastectomy; skin; surgical mesh; acellular dermal matrix
AB: Background: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. The aim of this prospective randomized trial was to compare the outcomes of direct IBBR augmented with an ADM (StratticeTM, LifeCell Cooperation) with those of two-stage IBBR. We report on the first results on the safety outcomes of the two procedures. Material and Methods: A non-blinded randomized controlled trial was conducted at eight hospitals in the Netherlands. Patients who intended to undergo skin-sparing mastectomy and immediate IBBR were randomized to one of two procedures for IBBR: one-stage ADM-assisted IBBR or two-stage IBBR. The primary endpoint was quality of life. In the present article, we assessed the effect of the procedure on the occurrence of adverse outcomes. Analyses were performed with logistic regression and the general linear model. The trial is registered in the Dutch National Trial Register (NTR TC 5446) and the public CCMO register in the Netherlands (NL41125.029.12). The inclusion of patients is completed. Results: Between April 14, 2013, and May 29, 2015, 140 patients were enrolled in the study. Eventually, 59 patients (91 breasts) in the one stage IBBR group and 59 (87 breasts) in the two-stage IBBR group were included for analysis. The overall medical complication rates (38.5% vs 10.3%, OR = 6.28, p = 0.001), the medical re-operation rates (32.6% vs 9.6%, OR = 3.96, p = 0.009) and the implant explantation rates (27.0% vs 2.4%, OR = 15.17, p = 0.001) were significantly higher in the one-stage group. This remained the case after controlling for multiple confounding factors (p < 0.001). Conclusions: Immediate one-stage ADM-assisted IBBR was associated with a significantly higher rate of post-operative complications compared with two-stage IBBR. There was no evidence of adverse tissue reactions to the ADM itself. These results indicate that immediate one-stage ADM-assisted IBBR should be considered very carefully.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/314/CN-01139314/frame.html

Record #16 of 37
ID: CN-01342780
AU: Baldelli I
AU: Cardoni G
AU: Franchelli S
AU: Fregatti P
AU: Friedman D
AU: Pesce M
AU: Ponte E
AU: Santori G
AU: Santi P
TI: Implant-Based Breast Reconstruction Using a Polyester Mesh (Surgimesh-PET): a Retrospective Single-Center Study
SO: Plastic and reconstructive surgery
YR: 2016
VL: 137
NO: 6
PG: 931e-9e
PM: PUBMED 27219260
PT: Comparative Study; Controlled Clinical Trial; Journal Article
KY: Breast Implants;Case-Control Studies;Mammaplasty [methods];Neoadjuvant Therapy;Polyesters;Postoperative Complications [etiology] [surgery];Radiotherapy, Adjuvant;Reoperation;Retrospective Studies;Risk Factors;Surgical Mesh;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0000000000002180
AB: METHODS: A single-center, retrospective, case-control study was performed from January 1, 2012, to December 31, 2013, by enrolling 206 breast reconstructions performed in 196 patients after oncologic (n = 200) or prophylactic (n = 6) mastectomy. Group A included 63 patients who underwent 70 immediate Surgimesh-PET-assisted breast reconstructions, and group B included 133 patients who underwent 136 standard breast reconstructions.RESULTS: No significant differences between groups occurred for early postoperative complications (p = 0.610), major complications that required surgical revision (p = 0.887), volume (p = 0.498) or width of the prosthesis (p = 0.201), skin-sparing mastectomy (p = 0.315), or axillary surgery (p = 0.265). Multivariate logistic regression showed that prior radiotherapy was the only significant variable for early postoperative complications in both whole series (p = 0.011) and group B (p = 0.046), whereas body mass index greater than 25 was an independent predictor in group A (p = 0.041). Prior radiotherapy was the only variable that reached statistical significance in the multivariate model for major complications in the whole series (p = 0.005).CONCLUSIONS: Short-term outcomes of Surgimesh-PET-based alloplastic breast reconstruction are promising. Further studies are needed to evaluate the long-term results of this surgical approach.CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.BACKGROUND: Although the introduction of acellular dermal matrices is considered one of the most important advancements in alloplastic breast reconstruction, costs and local policy limit their use in Italy. The purpose of this study was to assess short-term outcomes following Surgimesh-PET-based breast reconstruction.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/780/CN-01342780/frame.html

Record #17 of 37
ID: CN-01172549
AU: Barber M
TI: Comparison of three acellular collagen matrix materials to assist implant-based breast reconstruction
SO: European journal of surgical oncology.
YR: 2015
VL: 41
NO: 6
PG: S35
XR: EMBASE 72214298
PT: Journal: Conference Abstract
KY: *implant; *breast reconstruction; *breast surgery; surgical mesh; human; surgeon; surgery; breast; weight; erythema; preservation; patient; follow up; incision; chemotherapy; nipple; smoking; mastectomy; procedures; *collagen; pralidoxime mesilate
DOI: 10.1016/j.ejso.2015.03.065
AB: Introduction: The Edinburgh Breast Unit performed 419 implantbased breast reconstructions assisted by the use of acellular collagen matrix (ACM) between July 2008 and July 2014. Three types of matrix have been used for 402 of these procedures. The present study aimed to compare the use and outcome of Permacol, Strattice and Veritas to assist implantbased breast reconstruction. Methods: Cases of implant-based breast reconstruction using Permacol, Strattice and Veritas ACMs performed in Edinburgh were analysed with 6 months follow up. Results: Permacol (P), Strattice (S) and Veritas (V) were used in 72, 220 and 110 breast reconstructions respectively. Patient and breast weight, indications for mastectomy and proportion of bilateral cases did not differ between groups. Smoking, use of chemotherapy, incision used, associated axillary surgery, nipple preservation and use of fixed volume implant or expander did vary between groups apparently reflecting changes in practice over time. Rates of postoperative erythema varied significantly between groups (P 15.3%, S 7.7%, V 0.9%, chi = 13.6, p = 0.0011). Surgeons ranked materials V 1, S 2 and P 3 (chi-35.3, p < 0.0001). There was no difference in rates of unplanned surgery at 6 months (P 25%, S 27.7%, V 31.8%, chi = 1.1, p = 0.58) or implant loss at 6 months between groups (P 12.4%, S 11.4% and V 12.5% , chi = 0.1, p = 0.95). Conclusions: While differences exist in the characteristics of ACMs available to assist implant-based breast reconstruction and surgeons have clear preferences, there were no differences in outcome in terms of failure rate or unplanned reoperations in the present study.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/549/CN-01172549/frame.html

Record #18 of 37
ID: CN-01337124
AU: Hinchcliff KM
AU: Orbay H
AU: Busse BK
AU: Charvet H
AU: Kaur M
AU: Sahar DE
TI: Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: a prospective randomized trial
SO: Journal of plastic, reconstructive and aesthetic surgery. (no pagination), 2017
YR: 2017
VL: Date of Publication: September 04
XR: EMBASE 614947197
PT: Journal: Article In Press
KY: *acellular dermal matrix; biopsy; *breast reconstruction; cell growth; cell infiltration; clinical article; complication; controlled clinical trial; controlled study; cost benefit analysis; fibroblast culture; human; human tissue; inflammatory cell; patient satisfaction; questionnaire; randomized controlled trial; reimbursement; surgery; *surgical mesh
DOI: 10.1016/j.bjps.2017.02.024
AB: AlloDerm RTU and AlloMaxTM are two acellular dermal matrices (ADMs) used in implant-based breast reconstruction. In this study, we examined whether different processing methods for the ADMs lead to a disparity in histologic, clinical, and financial outcomes after breast reconstruction. Thirty patients undergoing implant-based breast reconstruction were randomized into AlloMax or AlloDerm arms (n = 15, each). ADM was placed at the time of immediate reconstruction. Patients were evaluated for complications on postoperative days 7, 14, and 30. During implant exchange, ADM biopsies were taken and compared histologically for vascular and cellular infiltration. Patient satisfaction was evaluated using the BRECON-31 questionnaire 1 year after implant exchange. A cost analysis was performed comparing the two ADMs. Patient demographics and complication rates were similar between the two groups (p > 0.05). Histologically, vessel density and fibroblast/inflammatory cell infiltrate were greater on the dermal side than on the implant side (p < 0.01) in both ADMs, suggesting greater vascular and cellular in-growth from the dermal side. Vessel density in the middle portion of the Allomax biopsies was significantly higher than the same site in the Alloderm biopsies (p < 0.05). The extent of fibroblast/inflammatory cell infiltration was similar in both arms (p > 0.05). The BRECON-31 satisfaction questionnaire yielded similar responses across all metrics between the two study arms. The negotiated price was slightly different when comparing the two ADMs, with no significant difference in ADM reimbursement. In this study, AlloDerm RTU and AlloMax were successfully used for implant-based breast reconstruction with comparable outcomes. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/124/CN-01337124/frame.html

Record #19 of 37
ID: CN-01402144
AU: Phillips BT
AU: Fourman MS
AU: Bishawi M
AU: Zegers M
AU: O'Hea BJ
AU: Ganz JC
AU: Huston TL
AU: Dagum AB
AU: Khan SU
AU: Bui DT
TI: Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial
SO: Journal of the american college of surgeons
YR: 2016
VL: 222
NO: 6
PG: 1116-1124
PM: PUBMED 27106640
PT: Comparative Study; Journal Article; Randomized Controlled Trial
KY: Administration, Oral;Adolescent;Anti-Bacterial Agents [administration & dosage] [therapeutic use];Antibiotic Prophylaxis [methods];Cefazolin [administration & dosage] [therapeutic use];Clindamycin [administration & dosage] [therapeutic use];Drug Administration Schedule;Infusions, Intravenous;Mammaplasty [methods];Mastectomy;Postoperative Care [methods];Prospective Studies;Surgical Wound Infection [diagnosis] [epidemiology] [prevention & control];Treatment Outcome;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
DOI: 10.1016/j.jamcollsurg.2016.02.018
AB: STUDY DESIGN: A noninferiority randomized controlled trial was designed in which TE-IBR patients received antibiotics either 24 hours postoperatively or until drain removal. The primary outcome was SSI, as defined by CDC criteria. Operative and postoperative protocols were standardized. Secondary endpoints included clinical outcomes up to 1 year and all implant loss, or reoperation.RESULTS: There were 112 TE-IBR patients (180 breasts) using ADM who were randomized into 2 study arms, with 62 patients in the 24-hour group and 50 in the extended group. Surgical site infection was diagnosed in 12 patients in the 24-hour group and 11 in the extended group (19.4% vs 22.0%, p = 0.82). The extended group had 7 patients who required IV antibiotics and an overall implant loss in 7 patients (14.0%). The 24-hour group had 4 patients who required IV antibiotics, with 3 requiring removal (4.8%). Patients with diabetes, postoperative seroma, or wound dehiscence were all more likely to develop SSI (p < 0.02).CONCLUSIONS: In a randomized controlled noninferiority trial, 24 hours of antibiotics is equivalent to extended oral antibiotics for SSI in TE-IBR patients. Additional multicenter trials will further assess this important aspect of TE-IBR postoperative care.BACKGROUND: Closed-suction drains, implants, and acellular dermal matrix (ADM) are routinely used in tissue expander-based immediate breast reconstruction (TE-IBR). Each of these factors is thought to increase the potential for surgical site infection (SSI). Although CDC guidelines recommend only 24 hours of antibiotic prophylaxis after TE-IBR, current clinical practices vary significantly. This study evaluated the difference in SSI between 2 different prophylactic antibiotic durations.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/144/CN-01402144/frame.html

Record #20 of 37
ID: CN-01300523
AU: Buonomo OC
AU: Varvaras D
AU: Montuori M
AU: Vanni G
AU: Venditti D
AU: Elia S
AU: Santurro L
AU: Granai AV
AU: Petrella G
AU: Rossi P
TI: One-stage immediate implant-based breast reconstruction, using biological matrices after conservative mastectomies: preliminary experience of the University Hospital of Tor Vergata, Rome
SO: Chirurgia (turin)
YR: 2015
VL: 28
NO: 6
PG: 221-226
XR: EMBASE 614003633
PT: Journal: Article
KY: *acellular dermal matrix; adult; article; blood analysis; body mass; *breast cancer/di [Diagnosis]; *breast cancer/su [Surgery]; *breast implant; *breast reconstruction; clinical article; controlled study; electrocardiography; female; hematoma/co [Complication]; histopathology; human; human tissue; Italy; necrosis; postoperative complication/co [Complication]; quality of life; randomized controlled trial; *simple mastectomy; thorax radiography; treatment outcome; wound dehiscence/co [Complication]; amiloride plus hydrochlorothiazide; antidiuretic agent; cortisone; *breast cancer; complication; controlled clinical trial; diabetes mellitus; exposure; hematoma; *implant; informed consent; middle aged; radiotherapy; randomization; reconstructive surgery; *university hospital; wound dehiscence; young adult
AB: Aim. Aim of our study was to achieve one-stage immediate implant based breast reconstruction, using biological matrices after conservative mastectomies, evaluate patients outcome and complications, in patients suffering from stage Tis-T1-T2 (<3 cm) breast cancer who underwent conservative mastectomy and reconstructive surgery. Methods. The inclusion criteria were: aged 20-65 years; nonsmokers; no diabetes or systemic connective disease; BMI<30; Patients should not be subjected to post-mastectomy radiotherapy; informed consent. During our study, through a randomization system, we used two different types of acellular dermal matrices (ADM): SurgiMend and Tutomesh. Results. From February 2012 to March 2014, 22 patients were enrolled, for a total of 38 reconstructions (average age 49 years). Ten patients did not have any mesh-related complications. Four patients showed a dehiscence with bilateral implant exposure, which required removal of the implants; minor wound dehiscence (healing within a month) was observed in 4 patients; 2 patients presented an asymmetry of the inframammary folds and a hematoma was found in two patients. Conclusion. The introduction of the ADM has helped to overcome several reconstructive limitations, allowing an immediate prosthetic reconstruction, after a conservative mastectomy. Complications have been drastically reduced due to an accurate selection of patients. In conclusion, one-stage breast reconstruction with acellular biological matrices, in selected patients, may be a new and realistic frontier in breast surgery, with the real possibility of providing women with breast cancer, a better quality of life compared to the traditional two-stage reconstruction.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/523/CN-01300523/frame.html

Record #21 of 37
ID: CN-01172531
AU: Humphries A
AU: Williams S
AU: Vidya R
AU: Cawthorn S
TI: Evaluation of the early post-operative effectiveness of a novel muscle-sparing breast reconstruction technique - Using Braxon (acellular dermal matrix)
SO: European journal of surgical oncology.
YR: 2015
VL: 41
NO: 6
PG: S71-S72
XR: EMBASE 72214431
PT: Journal: Conference Abstract
KY: *breast reconstruction; *acellular dermal matrix; *breast surgery; *muscle; implant; patient; human; breast; infection; seroma; wound; mastectomy; feasibility study; dancing; pain; cosmetic; sodium chloride
DOI: 10.1016/j.ejso.2015.03.200
AB: Introduction: We report initial results of a novel muscle-sparing subcutaneous implant breast reconstruction technique using a new Braxon ADM Methods: All patients who underwent muscle-sparing breast reconstruction in 2 Breast Units in 2014 were included in the study. The Braxon mesh which comes pre-shaped completely wraps the implant which is placed on the muscle, without detaching the pectoralis major. It is rehydrated in saline in 10 minutes. Results: A total of 22-patients underwent mastectomy and Braxon ADM plus implant reconstruction, 5 bilateral and 17 unilateral; a total of 27 reconstructions. The rate of implant loss was 3.7% (n = 1 due to wound breakdown), seroma 14% (n = 4) and infection 0%. Excellent cosmetic outcomes so far were obtained with a low complication rate. None of the patients reported experiencing pain or the "dancing breast syndrome" at 1 month Conclusions: The initial experience appears highly satisfactory. A feasibility study for a randomized trial comparing Braxon with submuscular /ADM implant reconstruction is planned.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/531/CN-01172531/frame.html

Record #22 of 37
ID: CN-01298157
AU: Dikmans REG
AU: Negenborn VL
AU: Bouman M-B
AU: Winters HAH
AU: Twisk JWR
AU: Ruhe PQ
AU: Mureau MAM
AU: Smit JM
AU: Tuinder S
AU: Eltahir Y
AU: Posch NA
AU: Steveninck-Barends JM
AU: Meesters-Caberg MA
AU: Hulst RRWJ
AU: Ritt MJPF
AU: Mullender MG
TI: Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial
SO: Lancet oncology
YR: 2016
VL: (no pagination)
XR: EMBASE 614221770
PT: Journal: Article In Press
KY: *acellular dermal matrix; adult; adverse drug reaction; adverse outcome; breast cancer; breast carcinoma; *breast reconstruction; clinical trial; controlled clinical trial; controlled study; doctor patient relation; female; funding; gene mutation; human; logistic regression analysis; major clinical study; mastectomy; multicenter study; Netherlands; nut; odds ratio; peroperative complication; phase 4 clinical trial; quality of life; randomization; randomized controlled trial; reoperation; risk factor; safety; side effect; surgery; *surgical mesh; young adult
DOI: 10.1016/S1470-2045%2816%2930668-4
AB: Background: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. Methods: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. Findings: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3.81, 95% CI 2.67-5.43, p<0.001), reoperation (3.38, 2.10-5.45, p<0.001), and removal of implant, ADM, or both (8.80, 8.24-9.40, p<0.001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. Interpretation: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. Funding: Pink Ribbon, Nuts-Ohra, and LifeCell. Copyright © 2016 Elsevier Ltd.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/157/CN-01298157/frame.html

Record #23 of 37
ID: CN-01047268
AU: Showalter BM
AU: Crantford JC
AU: Russell GB
AU: Marks MW
AU: DeFranzo AJ
AU: Thompson JT
AU: Pestana IA
AU: David LR
TI: The effect of reusable versus disposable draping material on infection rates in implant-based breast reconstruction: a prospective randomized trial
SO: Annals of plastic surgery
YR: 2014
VL: 72
NO: 6
PG: S165-9
PM: PUBMED 24374400
XR: EMBASE 24374400
PT: Comparative Study; Journal Article; Randomized Controlled Trial
KY: Breast Implantation;Breast Neoplasms [surgery];Disposable Equipment;Equipment Reuse;Prospective Studies;Surgical Drapes [microbiology];Surgical Wound Infection [prevention & control];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];adult; *breast augmentation; comparative study; controlled study; disposable equipment; female; human; microbiology; middle aged; prospective study; randomized controlled trial; recycling; *surgical drape
CC: SR-WOUNDS
DOI: 10.1097/SAP.0000000000000086
AB: OBJECTIVEThe aim of this study is to determine if a disposable draping system is superior to reusable draping materials in the prevention of implant-based breast reconstruction infection.METHODSThis single-institution, prospective, randomized, single-blinded, IRB-approved study enrolled women with breast cancer who were eligible for implant-based breast reconstruction. The primary endpoint was clinical infection by postoperative day 30. Secondary endpoints included all other complications encountered throughout the follow-up period and culture data. Demographic data recorded included patient age, body mass index, diabetes, smoking, chemotherapy, radiation, and follow-up. Procedural data recorded included procedure type, procedure length, estimated blood loss, use of acellular dermal matrix, use of muscle flap, and inpatient versus outpatient setting.RESULTSFrom March 2010 through January 2012, 107 women were randomized and 102 completed the study. Five patients were determined not to be candidates for reconstruction after randomization. There were 43 patients in the Reusable Group and 59 patients in the Disposable Group. There were no significant differences in patient demographic data, procedural data, or the type of procedure performed between groups. In the Reusable Group, there were 5 infections (12%) within 30 days compared to 0 (0%) infections in the Disposable Group (P = 0.012). There was no significant difference in secondary complications. There was a trend for positive wound cultures (11% vs. 3%, P = 0.10) and positive drape cultures (17% vs.4%, P = 0.08) in patients with clinical infection. There were no differences in the number of colony-forming units or positive cultures between groups.CONCLUSIONSDisposable draping material is superior to a reusable draping system in the prevention of clinical infection within the immediate postoperative period. This study did not demonstrate a clear link between intraoperative culture data and the development of clinical infection. A completely disposable gown and draping system is recommended during implant-based breast reconstruction.BACKGROUNDClinical infection remains a significant problem in implant-based breast reconstruction and is a physical and emotional strain to the breast reconstruction patient. Bacterial strikethrough of draping and gown material is a likely source of infection. Strategies to reduce infection in implant-based breast reconstruction are essential to improve patient outcomes.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/268/CN-01047268/frame.html

Record #24 of 37
ID: CN-01374313
AU: Vidya R
AU: Masia J
AU: Cawthorn S
AU: Berna G
AU: Bozza F
AU: Gardetto A
AU: Kolacinska A
AU: Dell'Antonia F
AU: Tiengo C
AU: Bassetto F
AU: Caputo GG
AU: Governa M
TI: Evaluation of the effectiveness of the prepectoral breast reconstruction with Braxon dermal matrix: first multicenter European report on 100 cases
SO: Breast journal
YR: 2017
VL: (no pagination)
XR: EMBASE 616036405
PT: Article In Press
KY: *acellular dermal matrix; breast implant; *breast reconstruction; clinical trial; *comparative effectiveness; controlled clinical trial; *controlled study; Europe; female; follow up; graft failure; hardness; human; joint; major clinical study; male; multicenter study; necrosis; nipple; pain; patient selection; *pectoralis major muscle; practice guideline; prospective study; rotation; surgeon; surgical technique; touch; wound
DOI: 10.1111/tbj.12810
AB: We report the outcomes of the European prospective study on prepectoral breast reconstruction using preshaped acellular dermal matrix for complete breast implant coverage. Seventy-nine patients were enrolled between April 2014 and August 2015 all over Europe using a single protocol for patient selection and surgical procedure, according to the Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons joint guidelines for the use of acellular dermal matrix in breast surgery. The preshaped matrix completely wraps the breast implant, which is placed above the pectoralis major, without detaching the muscle. A total of 100 prepectoral breast reconstructions with complete implant coverage were performed. This series, with mean follow-up of 17.9 months, had two cases of implant loss (2.0%) including one necrosis of the nipple and one wound breakdown (1.0% respectively). No implant rotations were observed. Good cosmetic outcomes were obtained with natural movement of the breasts and softness to the touch; none of the patients reported experiencing pain or reduction in the movements of the pectoralis major muscle postoperatively. The use of preshaped acellular dermal matrix for a complete breast implant coverage in selected patients is safe and gives satisfactory results, both from the aesthetic view point and the low postoperative complication rates. Further studies reporting long-term outcomes are planned. Copyright © 2017 Wiley Periodicals, Inc.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/313/CN-01374313/frame.html

Record #25 of 37
ID: CN-00640532
AU: Nipshagen MD
AU: Hage JJ
AU: Beekman WH
TI: Use of 2-octyl-cyanoacrylate skin adhesive (Dermabond) for wound closure following reduction mammaplasty: a prospective, randomized intervention study
SO: Plastic and reconstructive surgery
YR: 2008
VL: 122
NO: 1
PG: 10-18
PM: PUBMED 18594354
XR: EMBASE 355000523
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Administration, Topical;Cyanoacrylates [administration & dosage];Mammaplasty;Prospective Studies;Tissue Adhesives [administration & dosage];Wounds and Injuries [etiology] [therapy];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];adult; aged; article; *breast reduction; clinical article; clinical trial; controlled clinical trial; controlled study; female; follow up; human; intermethod comparison; outcome assessment; patient satisfaction; priority journal; randomized controlled trial; rating scale; scar formation; single blind procedure; surgical patient; surgical wound; suturing method; therapy effect; visual analog scale; wound assessment; *wound closure; *2 octyl cyanoacrylate; *tissue adhesive; unclassified drug
CC: SR-WOUNDS
DOI: 10.1097/PRS.0b013e318171524b
AB: METHODSThe authors conducted a prospective, randomized, controlled clinical intervention study in which the scar characteristics after use of skin adhesive were compared with those after suture closure. Bilateral reduction mammaplasty was performed in 50 patients. The method of closure (sutures versus skin adhesive) applied to each breast was determined randomly, using each patient as her own control. Scars were assessed by the patient and by a blinded panel, at 1 week, 6 weeks, and 6 months after surgery, using a visual analogue scale, the modified Hollander Wound Evaluation Scale, and the Patient and Observer Scar Assessment Scale.RESULTSBoth patients and panelists expressed an overall preference for the adhesive side as of 1 week after surgery. Patients' visual analogue scale scores for scar comfort and scar appearance and panelists' visual analogue scale scores for aesthetic outcome were significantly better for the adhesive side after 6 weeks and 6 months (p < 0.05), as was the total Hollander Wound Evaluation Scale score of the panelists after 6 weeks (p < 0.02). The total Patient and Observer Scar Assessment Scale score after 6 months was significantly better for the adhesive side according to the patients (p < 0.01), but not according to the panelists (p = 0.11).CONCLUSIONThe authors conclude that 2-octyl-cyanoacrylate is a sound alternative for wound closure.BACKGROUND2-Octyl-cyanoacrylate skin adhesive may be used for surgical wound closure. However, its use in plastic surgery has not been properly assessed.
US: http://cochranelibrary-wiley.com/o/cochrane/clcentral/articles/532/CN-00640532/frame.html

Record #26 of 37
ID: CN-01194496
TI: Further evidence that human acellular dermal matrix decreases inflammatory markers of capsule formation in implant-based breast reconstruction
SO: Aesthetic surgery journal
YR: 2015
VL: 35
NO: 1
PG: 40-47
PM: PUBMED 25568233
XR: EMBASE 607724535
PT: Journal: Article
KY: *acellular dermal matrix; adult; article; B lymphocyte; blood vessel; *breast; *breast capsule; *breast implant; *breast reconstruction; clinical article; controlled study; endothelium cell; human; *human acellular dermal matrix; human tissue; immunohistochemistry; macrophage; myofibroblast; priority journal; quantitative study; T lymphocyte; tissue expander; tissue implant; alpha smooth muscle actin/ec [Endogenous Compound]; CD20 antigen/ec [Endogenous Compound]; CD3 antigen/ec [Endogenous Compound]; CD31 antigen/ec [Endogenous Compound]; CD68 antigen/ec [Endogenous Compound]; collagen type 1/ec [Endogenous Compound]; collagen type 3/ec [Endogenous Compound]; biopsy; clinical trial; contracture; controlled clinical trial; *implant; inflammatory cell; longevity; rank sum test; single blind procedure; thickness; CD20 antigen; CD3 antigen; CD31 antigen; CD68 antigen; collagen type 1; smooth muscle actin
DOI: 10.1093/asj/sju014
AB: Background: Human acellular dermal matrix (HADM; previously termed "acellular cadaveric dermis") may limit inflammatory changes believed to play a role in capsular contracture, a common complication of implant-based breast reconstruction. Objectives: Differences between HADM and native breast capsule specimens were evaluated by immunohistochemical analysis of key inflammatory markers involved in capsule formation. Methods: Twenty consecutive patients underwent immediate, 2-stage, implant-based breast reconstruction with dual-plane HADM. During tissue expander-implant exchange, full-thickness biopsies of biointegrated HADM and native breast capsule (internal control) from the tissue-expander envelope were obtained. Immunohistochemical analysis was performed for endothelial cells (CD31), B cells (CD20), T cells (CD3), macrophages (CD68), collagen I and III, and myofibroblasts (a-smooth muscle actin). Observed levels of marker labeling were semiquantitatively scored from 0 (none) to 3 (severe) by a blinded histopathologist and were statistically analyzed with the Wilcoxon rank sum test. Results: A bilateral sample was obtained from 1 patient; all other samples were unilateral. Compared with capsule samples from native breast tissue, HADM samples had significantly lower levels of all inflammatory markers (P

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