Acellular Dermal Matrix without Basement membrane in Immediate Prepectoral Breast Reconstruction: A Prospective, Randomized Controlled Trial

Abstract

Background: The acellular dermal matrix (ADM) has become popular in various reconstructive surgeries of different regions. There are different needs depending on the clinical applications including breast, abdominal wall, and any other soft tissue reconstruction. Removal of the basement membrane (BM), which consists of collagen fibers, may help achieve natural and soft breast reconstruction that require highly elastic ADMs. Given the lack of knowledge of the effectiveness of the ADM without the BM, we compared the clinical outcomes of ADMs with and without BM in breast reconstruction. Methods: We conducted a prospective, single-blinded, randomized controlled trial to evaluate differences in clinical outcomes. The patients were randomized into ADM with BM and without BM groups. Both groups underwent immediate prepectoral direct-to-implant breast reconstruction. Demographics, surgical outcome, and breast shape change using nipple position were compared between the two groups. Results: A total of 56 patients were divided into two groups: ADM with BM (n=30, 53.6%) and ADM without BM (n=26, 46.4%). Clinical and surgical demographics were similar between the two groups. The authors detected no statistically significant differences in the overall rate of complications and breast shape change between the two groups. However, the rate of seromas was higher in the ADM with BM group than that in the ADM without BM group (10% vs. 0%, P=0.09). Conclusion: The two groups showed similar surgical outcomes. The use of ADM without BM in implant-based breast reconstruction was safe with its mechanical properties of lower tensile strength and higher elasticity.