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Reducing Wound Complications in Breast Surgery Using hACM
Sponsor: Rutgers, The State University of New Jersey
Summary
The purpose of this study is to evaluate whether intraoperative application of human amnion chorion membrane (hACM) improves wound healing and scar outcomes in breast surgery. Despite advancements in surgical technique, incisional complications such as dehiscence, infection, and hypertrophic scarring remain common in both reconstructive and reduction breast procedures. These complications can delay recovery, impair aesthetics, and necessitate revision procedures.
Official title: Reducing Wound Complications in Breast Surgery Using Human Amnion-Chorion Membrane (hACM): A Randomized Paired-Design Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-11-01
Completion Date
2028-06-30
Last Updated
2026-10-20
Healthy Volunteers
Yes
Conditions
Interventions
Dehydrated Human Amnion Chorion Membrane
Salera Mini Membrane (MTF Biologics) is a dehydrated human amnion-chorion membrane allograft evaluated as an intraoperative adjunct to standard surgical wound closure. The membrane will be placed in the subcutaneous tissue at the randomly assigned treatment site before final multilayer skin closure. In bilateral breast reduction, one breast will receive the membrane, while the contralateral breast receives standard closure. In breast reconstruction, either the medial or lateral half of the inframammary fold incision will receive the membrane, with the opposite half serving as the control. The allograft will be applied once during surgery and will remain in place following closure.