Reducing Wound Complications in Breast Surgery Using hACM
Surgical Wound Healing · Scar Tissue
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - Not specified
- Sex eligible
- Female
- Healthy volunteers
- Accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled to undergo bilateral breast reduction mammaplasty or immediate/delayed post-mastectomy breast reconstruction at Rutgers University Hospital or Robert Wood Johnson University Hospital
- Able to provide written informed consent in English or Spanish
- Able to attend postoperative follow-up visits at 1 week, 3/4 weeks, 12 weeks, and 24 weeks
Exclusion Criteria:
- Known sensitivity or allergy to human allograft tissue
- Not medically cleared for surgery
- Inability to provide written informed consent
- Inability or unwillingness to complete required follow-up visits
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- Single masked
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
Breast Reconstruction
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
Dehydrated Human Amnion Chorion Membrane BIOLOGICAL
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of Postoperative Incisional Wound Complications
Time frame: 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.
Secondary measures
Postoperative Tissue Edema Assessed by Tissue Dielectric Constant
Time frame: 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.
Postoperative Pain Assessed by Numeric Rating Scale
Time frame: 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.
Postoperative Scar Quality Assessed by Patient and Observer Scar Assessment Scale
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Rutgers, The State University of New Jersey
- Study start
- Nov 1, 2026 Estimated
- Primary completion
- Nov 10, 2026 Estimated
- Study completion
- Jun 30, 2028 Estimated
- First posted
- Oct 20, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
Official study title
Reducing Wound Complications in Breast Surgery Using Human Amnion-Chorion Membrane (hACM): A Randomized Paired-Design Clinical Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026