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

Area of Science:

• Plastic Surgery
• Reconstructive Surgery
• Oncology

Background:

• Acellular dermal matrix (ADM) is widely used in two-stage prepectoral breast reconstruction.
• Concerns exist regarding ADM's impact on infection rates and overall benefits.
• This study investigates ADM's noninferiority compared to no ADM in prepectoral reconstruction.

Purpose of the Study:

• To evaluate if acellular dermal matrix (ADM) is noninferior to no ADM in two-stage prepectoral breast reconstruction.
• To compare major postoperative complications within 90 days between ADM and no ADM groups.
• To assess secondary outcomes including minor complications, patient-reported outcomes (BREAST-Q), and pain.

Main Methods:

• A single-center, cluster-randomized noninferiority trial involving 368 patients (623 breasts).
• Patients were assigned to either ADM or no ADM groups for two-stage prepectoral reconstruction.
• Primary endpoint: proportion of breasts with major complications (infection, reoperation, explantation) within 90 days. Noninferiority margin set at 7%.

Main Results:

• Major complication rates were similar: 13.2% with ADM versus 13.1% without ADM, confirming noninferiority (upper bound of 95% CI < 7%).
• Minor complications, such as seroma, showed no significant difference between groups (20% vs. 27.4%, p=0.056).
• BREAST-Q scores and postoperative pain were comparable across both groups at 30 and 90 days.

Conclusions:

• Two-stage prepectoral breast reconstruction with ADM is noninferior to reconstruction without ADM regarding major 90-day postoperative complications.
• ADM use demonstrated comparable minor complications, patient-reported outcomes, and pain levels.
• Findings support the routine use of ADM as a safe option, though long-term outcome data is still needed.