Reducing Wound Complications in Breast Surgery Using hACM

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• Cicatrix 317

Cicatrix

317 studies on the registry are indexed under Cicatrix; 54 are open to participants now.

This study's planned enrollment of 200 is above the median of 40 across 260 interventional studies indexed under Cicatrix.

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 504 studies on the registry; 131 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.

Study arms

• Experimental
  Breast Reduction

  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

• Experimental
  Breast Reconstruction

  Participants undergoing post-mastectomy 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

Interventions

• BiologicalDehydrated 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.

Primary outcomes

1. Incidence of Postoperative Incisional Wound Complications

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

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

Secondary outcomes

1. Postoperative Tissue Edema Assessed by Tissue Dielectric Constant

   Tissue dielectric constant (TDC) will be measured using the MoistureMeterD Compact (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.

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

2. Postoperative Pain Assessed by Numeric Rating Scale

   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.

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

3. Postoperative Scar Quality Assessed by Patient and Observer Scar Assessment Scale

   Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), incorporating both patient-reported and blinded observer assessments. The scale evaluates scar characteristics, including appearance, texture, and patient-reported symptoms. Scores from hACM-treated and untreated sites will be compared to determine differences in postoperative scar quality.

   Time frame: 3-4 weeks, 12 weeks, and 24 weeks postoperatively.

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) collected during the study will be made available to qualified researchers upon reasonable request. Shared data will include participant demographics, relevant medical history and comorbidities, surgical characteristics, treatment allocation, and postoperative outcomes. Specifically, data will include wound complications (dehiscence, infection, seroma, hematoma, delayed healing, skin flap necrosis, and unplanned reoperation), tissue dielectric constant measurements, Numeric Rating Scale pain scores, and Patient and Observer Scar Assessment Scale scores at all applicable follow-up time points.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: IPD and supporting documentation will be made available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

Access criteria: IPD and supporting documentation will be available to qualified researchers upon reasonable request for legitimate scientific purposes. Shared materials may include participant-level clinical data, treatment allocation, postoperative outcomes, study protocol, and statistical analysis plan. Researchers may request access by contacting the Principal Investigator, Dr. Edward Lee, at Rutgers New Jersey Medical School. Requests will be reviewed by the investigative team and, when applicable, the institution's research oversight committee. Approved researchers will receive access through a secure, institutionally approved data-sharing platform following execution of an appropriate data use agreement.

Data sharing details ↗ · n