Dataset Information

Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings.

ABSTRACT: Background:Several acellular dermal matrices (ADMs) can be used to provide soft-tissue support for post- and prepectoral prosthetic breast reconstructions. Yet, several recent meta-analysis suggest that due to a lack of rigorous evaluation in the setting of head-to-head prospective randomized control trials, few reliable conclusions regarding performance outcomes can be drawn. We compare Cortiva 1?mm to AlloDerm RTU in the setting of submuscular reconstruction in one study, and prepectoral in the second. Moreover, we present the findings from the interim analysis in our submuscular study. Methods:Using a single-blinded prospective randomized control trial design, we compare outcomes in 180 patients undergoing submuscular breast reconstruction with 16?×?8?cm ADM support (either Cortiva 1?mm or AlloDerm RTU). A parallel study evaluates 16?×?20?cm sheets of these ADMs in 180 patients undergoing prepectoral reconstructions. Time to drain removal, complications, fill volumes, patient-reported outcomes, and narcotic consumption are prospectively evaluated. Results:Interim analysis of 59 breasts in the submuscular study arm (Cortiva n = 31; AlloDerm n = 28) revealed no statistically significant differences with respect to outcome. At the time of interim analysis, the AlloDerm RTU group contained a higher proportion of never-smokers (P = 0.009), while patients implanted with Cortiva 1?mm received a larger tissue expander (P = 0.02). Conclusion:We present a protocol for a robust randomized control trial to evaluate outcomes in both submuscular and prepectoral prosthetic breast reconstruction assisted by 2 distinct types of ADM. Our interim analysis reveals no evidence of inferiority of outcomes in a comparison of AlloDerm to Cortiva.

SUBMITTER: Parikh RP

PROVIDER: S-EPMC6414118 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings.

Parikh Rajiv P RP Tenenbaum Marissa M MM Yan Yan Y Myckatyn Terence M TM

Plastic and reconstructive surgery. Global open 20181113 11

<h4>Background</h4>Several acellular dermal matrices (ADMs) can be used to provide soft-tissue support for post- and prepectoral prosthetic breast reconstructions. Yet, several recent meta-analysis suggest that due to a lack of rigorous evaluation in the setting of head-to-head prospective randomized control trials, few reliable conclusions regarding performance outcomes can be drawn. We compare Cortiva 1 mm to AlloDerm RTU in the setting of submuscular reconstruction in one study, and prepector ...[more]

PMID: 30881804

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Project description:Background and objectiveWith the incorporation of autologous fat grafting, acellular dermal matrix (ADM) products, and nipple-sparing mastectomy, prepectoral device placement has become more popular in selected patients when compared to partial submuscular (dual plane) or complete submuscular device placement. In this article, we aimed to present a review of the current state-of-the-art for implant-based breast reconstruction (IBBR) using expanders. Additionally, we present a case series of our experience with IBBR evaluating perioperative outcomes, complications, and patient-reported outcomes (PRO).MethodsFor our series, we retrospectively evaluated adult female patients undergoing 2-stage immediate IBBR after total mastectomy between 2011 and 2021. We performed a systematic search across PubMed MEDLINE for articles evaluating outcomes of prepectoral versus subpectoral two-stage IBBR with expanders published from database inception through February 28th, 2023.Key content and findingsBoth prepectoral and subpectoral are safe alternatives for two-stage IBBR. Due to current advancements in the field of breast reconstruction, prepectoral IBBR has gained popularity and has a comparable rate of complications compared to a subpectoral approach in selected patients according to high-quality articles. In patients with several comorbidities, current tobacco use, history of preoperative radiation, and limited perfusion of the mastectomy flaps, subpectoral device placement should be given special consideration as a layer of vascularized tissue can decrease the risk of major complications or unplanned procedures. As prepectoral device placement does not require dissection of the pectoral muscles, faster recovery, better implant position, decreased pain, and a shorter time to complete expansion is expected. The plane of reconstruction does not seem to significantly affect the time for expander-to-implant exchange or PRO for quality-of-life (QOL) according to most studies.ConclusionsPrepectoral and subpectoral IBBR demonstrated a comparable rate of complications in selected patients. Nonetheless, perioperative outcomes seem to be improved using a prepectoral approach in terms of reduced pain, reduced time to conclude outpatient expansions, and less animation deformity.

Project description:BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Dataset Information

Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings.

Publications

Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings.

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