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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Wound Complications in Breast Surgery Using Human Amnion-Chorion Membrane (hACM): A Randomized Paired-Design Clinical Trial
- ClinicalTrials.gov ID
- NCT07881939
- Acronym / sponsor ID
- Pro2025002216
- Conditions
- Surgical Wound Healing, Scar Tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Reduction | Experimental | Biological: Dehydrated Human Amnion Chorion MembraneParticipants 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. |
| Breast Reconstruction | Experimental | Biological: Dehydrated Human Amnion Chorion MembraneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydrated Human Amnion Chorion MembraneSalera 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. | Biological | Breast Reconstruction, Breast Reduction |
Primary outcome
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.
3 secondary outcomes
Postoperative Tissue Edema Assessed by Tissue Dielectric Constant
Time frame: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
Postoperative Pain Assessed by Numeric Rating Scale
Time frame: 1 week, 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
Postoperative Scar Quality Assessed by Patient and Observer Scar Assessment Scale
Time frame: 3-4 weeks, 12 weeks, and 24 weeks postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Kim, BS study director
Rutgers University
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (2018157778, cdk72@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.