Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized...

Acellular dermal matrix (ADM) is frequently used in two-stage prepectoral breast reconstruction; however, concerns persist regarding increased infection rates with its use and overall benefits. This randomized controlled trial evaluated whether ADM in prepectoral reconstruction is noninferior to the alternative of no ADM with regard to major postoperative complications.

In this single-center, cluster-randomized noninferiority trial, 368 patients (623 breasts) undergoing two-stage prepectoral reconstruction were assigned to ADM or no ADM groups. The primary endpoint was the proportion of breasts with at least one major complication (infection, reoperation, or explantation) within 90 days. Noninferiority was defined as the upper bound of the one-sided 95% confidence interval (CI) for the difference in complication rates (with ADM minus no ADM) being less than the pre-specified margin of 7%. Secondary outcomes included minor complications, BREAST-Q scores, and pain.

Major complications were similar between groups (ADM: 13.2% vs. no ADM: 13.1%; one-sided 95% CI upper bound below 7%), confirming noninferiority. Minor complications, including seroma (ADM: 20%, no ADM: 27.4%; p=0.056) showed no significant difference. BREAST-Q scores were comparable at 30 (ADM: 60, no ADM: 55; p=0.2) and 90 days (76 in both groups; p=0.3). Postoperative pain was similar between groups.

Two-stage prepectoral breast reconstruction with ADM was noninferior to reconstruction without ADM regarding major 90-day postoperative complications, with comparable minor complications, patient-reported outcomes, and pain. These findings support the routine use of ADM as a safe option. Long-term follow-up comparing relevant clinical outcomes is needed to clarify the benefits of ADM.Trial Registration: Clinicaltrials.gov NCT05316324.