Reducing Wound Complications in Breast Surgery Using hACM

Participants undergoing bilateral breast reduction will receive intraoperative application of human amnion-chorion membrane (hACM) to one randomly selected breast, while the contralateral breast will undergo standard surgical wound closure without hACM. Each participant will serve as their own control. Postoperative wound complications, tissue edema, pain, and scar quality will be compared between treated and untreated breasts.

Biological: Dehydrated Human Amnion Chorion Membrane

Participants undergoing breast reconstruction will receive intraoperative application of human amnion-chorion membrane (hACM) to one randomly selected half of the inframammary fold incision (medial or lateral), while the opposite half will undergo standard surgical wound closure without hACM. Each participant will serve as their own control. Postoperative wound complications, tissue edema, pain, and scar quality will be compared between treated and untreated incision segments.

Biological: 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.

Plazo: Through 24 weeks postoperatively, with assessments at 1 week, 3-4 weeks, 12 weeks, and 24 weeks.

Types of incisional wound complications include: wound dehiscence, surgical site infection, seroma, hematoma, delayed incisional healing, unplanned return to the OR.

Plazo: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.

Tissue dielectric constant (TDC) will be measured using the LymphScanner (Delfin Technologies) to objectively quantify localized tissue water content. Measurements will be obtained at three standardized locations along the surgical incision, including the midpoint of the full incision and the midpoints of the medial and lateral segments (or corresponding anatomical segments). Measurements from hACM-treated and untreated sites will be compared. The measurements range from 0-100%, with the higher number representing greater water content/edema.

Plazo: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.

Patient-reported postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at each postoperative visit and compared between hACM-treated and untreated sites.

Plazo: 3-4 weeks, 12 weeks, and 24 weeks postoperatively.

Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), incorporating both patient-reported and blinded observer assessments. Each item is rated from 1 to 10, producing a total score ranging from 6 to 60, with lower scores indicating better scar quality. Scores from hACM-treated and untreated sites will be compared to determine differences in postoperative scar quality.

Reducing Wound Complications in Breast Surgery Using Human Amnion-Chorion Membrane (hACM): A Randomized Paired-Design Clinical Trial