AlloDerm® versus Cortiva® in implant-based breast reconstruction: framework for a systematic review and meta-analysis of clinical and economic outcomes.

BACKGROUND: Acellular dermal matrices (ADMs) such as human-derived AlloDerm and Cortiva are widely used in implant-based breast reconstruction (IBBR) to provide soft-tissue support. AlloDerm is considered a standard ADM, while Cortiva (and its thinner variant, Cortiva Silhouette) is a newer alternative that may offer cost advantages. Individual studies including a recent randomized trial suggest Cortiva is non-inferior to AlloDerm in terms of clinical outcomes, with some evidence of lower seroma rates, and reduced material cost with Cortiva. To date, no comprehensive synthesis has focused specifically on comparing AlloDerm versus Cortiva in breast reconstruction. This protocol describes a systematic review and meta-analysis to evaluate differences in surgical complications, patient-reported outcomes, and cost between AlloDerm and Cortiva. METHODS: We will search MEDLINE (PubMed), Embase, Scopus, Web of Science, and the Cochrane Library for studies comparing AlloDerm to Cortiva in implant-based breast reconstruction. Both randomized controlled trials and observational studies (cohort or case-control designs) will be included. Two reviewers will independently screen titles/abstracts and full texts against predefined inclusion criteria, and extract data using a standardized form. Outcomes of interest include complication rates (seroma, infection, capsular contracture, implant malposition); patient-reported outcomes (BREAST-Q scores); revision or explantation surgeries; and cost measures. Study quality will be appraised using the Cochrane risk-of-bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. We will perform meta-analysis using random-effects models if ≥ 2 studies report comparable outcomes. Risk ratios or odds ratios will be pooled for dichotomous outcomes, and mean differences for continuous outcomes, with 95% confidence intervals. Heterogeneity will be assessed with the I2 statistic and Cochran Q test. Subgroup analyses will be performed to minimize confounding, and sensitivity analyses (e.g., excluding high risk-of-bias studies) are planned to assess robustness of findings. DISCUSSION: This review will synthesize the available evidence comparing AlloDerm and Cortiva ADMs in breast reconstruction. Given that a high-level RCT found no significant differences in overall failure or complications and multiple cohort studies indicate equivalent safety profiles, our meta-analysis will clarify if any true differences exist in complication rates or patient outcomes. We will also quantify any advantages of Cortiva in lowering costs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2025 CRD420251078451. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251078451.