Surgical Wound HealingPhase 4NCT07881939
Reducing Wound Complications in Breast Surgery Using hACM
A Phase 4 study testing Dehydrated Human Amnion Chorion Membrane in people with Surgical Wound Healing and Scar Tissue, run by Rutgers, The State University of New Jersey.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Healing, Scar Tissue
- What is being tested?
- Dehydrated Human Amnion Chorion Membrane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Wound Complications in Breast Surgery Using Human Amnion-Chorion Membrane (hACM): A Randomized Paired-Design Clinical Trial
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.
- Conditions
- Surgical Wound Healing, Scar Tissue
- Being tested
- Dehydrated Human Amnion Chorion Membrane
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated Human Amnion Chorion MembraneBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Reduction | Experimental | 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. Receives: Biological: Dehydrated Human Amnion Chorion Membrane |
| Breast Reconstruction | Experimental | 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. Receives: Biological: Dehydrated Human Amnion Chorion Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 24 weeks postoperatively, with assessments at 1 week, 3-4 weeks, 12 weeks, and 24 weeks.
Secondary outcomes (3)
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.
Measured: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
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.
Measured: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
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.
Measured: 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Lee, MD, Rutgers, The State University of New Jersey
- Investigators
- Christian Kim, BS, Study director, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881939
- Sponsor's protocol ID
- Pro2025002216
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.