Wound HealingNCT06921148
Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
A study testing Sylk Wound Dressing and Dermabond/Prineo Dressing in people with Wound Healing, run by Indiana University at 1 site in United States.
Trial summary
This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Sylk Wound Dressing and Dermabond/Prineo Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 14 Jun 2028
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.
- Physicians will be plastic surgeons in the IU Health system
Who cannot join
- Patients with a history of breast cancer.
- Patients with prior history of breast surgery.
- Patients with a prior history of radiation to the chest wall/breast.
- Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).
- Patients with a history of documented allergic reaction to Dermabond/Prineo or Silk Bioprotein dressing, or any of the constituents that make up these dressings.
- Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
- Physicians not in the IU Health system will not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Ivan Hadad, MD, (317) 944-5000, ihadad@iu.edu
About this study
Official title: The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.
Read the detailed description
Medical adhesive-related skin injuries (MARSIs) affect approximately 1.5 million patients annually in the United States are one of the most overlooked complications of surgery. MARSI is a condition secondary to the use of surgical tapes, dressings, and tissue adhesives which can lead to a host of postoperative complications such as allergic contact dermatitis (ACD), wound dehiscence, surgical-site infections (SSIs), and in extreme cases sepsis. A commonly utilized surgical dressing is the Dermabond and Dermabond/Prineo system. Allergic dermatitis to these dressings is an increasingly reported adverse reaction in multiple surgical specialties; moreover, the FDA has found that approximately 75% of the adverse events reported with Dermabond/Prineo were related to ACD. These dressings are reported to produce mechanical skin tears and blisters, which can damage epidermal cells and compromise the protective skin layer, making patients susceptible to infection and other wound-related complications.
Silk bioprotein dressings have shown promise due to their biocompatibility and regenerative properties, potentially reducing MARSI compared to the Dermabond/Prineo system, which remains a standard choice for many surgical procedures. A plethora of preclinical and clinical studies have demonstrated the safety and efficacy of silk in tissue engineering, and recently only two studies have utilized this technology as a surgical site dressing demonstrating its safety and utility compared to other standard wound dressings such as Dermabond/Prineo. Despite these findings, these recent studies utilized a small cohort of patients and had a relatively diverse patient population in regard to type of surgery performed. Therefore, the comparative efficacy of Silk bioprotein dressing remains undetermined. Silk bioprotein dressings and Dermabond/Prineo are both currently used in the IU Health system as surgical wound dressings.
Double-incision mastectomy, a common procedure for female-to-male gender affirmation surgery, is a relatively standardized procedure in terms of wound dimensions, tissue dissection, and closure tension; additionally, all patients undergoing this procedure by definition will receive bilateral procedures. This uniformity allows for a unique study design where patients can serve as their own internal controls. Prior to the introduction of Silk bioprotein dressings to the IU Health/Eskenazi hospital systems, the majority of these surgical wounds were dressed with Dermabond/Prineo, whereas now it is mixed based on product availability. Our study aims to better elucidate the wound healing outcomes of Silk dressing using a patient population that are not only undergoing a fairly standardized surgical procedure, but could also serve as their own internal controls. Our decision would dress one incision with silk dressings, and the other with Dermabond/Prineo. This approach minimizes variability and imposes minimal risk, ensuring a robust comparison of outcomes between the two dressings, and will add data to the current literature on the utility of silk bioprotein dressings in surgical wound care.
- Conditions
- Wound Healing
- Being tested
- Sylk Wound Dressing, Dermabond/Prineo Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sylk Wound DressingDevice
Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.
Dermabond/Prineo DressingDevice
Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.
| Study group | Role | What they receive |
|---|---|---|
| Sylk Wound Dressing | Experimental | Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls. Receives: Device: Sylk Wound Dressing |
| Dermabond/Prineo Dressing | Experimental | Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls. Receives: Device: Dermabond/Prineo Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Adhesive-Related Skin Injury (MARSI)
This outcome will assess the incidence and time point postoperatively of MARSIs in both dressing types (Silk and Dermabond/Prineo) used on the chest walls of patients enrolled in this study. This will be determined via physical examination and photo documentation of patient surgical incisions.
Measured: 12 weeks postoperatively
Timeing of premature removal of postoperative dressing
This objective will the post-operative time at which dressings are removed due to adverse events and/or intrinsic properties of the dressing falling off prior to what was instructed by the operating surgeon. This will be determined by physical exam or via patient-reported outcomes
Measured: 12 weeks postoperatively
Postoperative wound infection and dehiscence
This objective will assess the incidence and time postoperatively of wound dehiscence or infection on the postoperative incisions of patients. This will be determined by clinical examination and documented photographs of patient's incisions.
Measured: Any time up until 12 weeks postoperatively
Secondary outcomes (2)
Subjective wound healing outcome by patient
Patients will have their subjective impression of how their scars heal via phone survey
Measured: Patients will have their subjective opinions evaluated 1, 2, 4, and 8-12 weeks post-operatively via phone survey
Subjective wound healing outcome of scar by blinded plastic surgeons
Plastic surgeons not involved in the study/direct patient care will receive blinded postoperative photos of patient surgical scars to determine which side of chest, if any, had better wound healing/scar outcomes
Measured: 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Sep 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion14 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All patients who undergo the intervention will act as their own controls. Patients undergo these surgeries bilaterally, meaning one side of their chest will have the interventional dressing applied, and the other side of their chest will have the control dressing applied.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Hadad, Indiana University
- Investigators
- Ivan Hadad, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921148
- Sponsor's protocol ID
- 25905
- Status last verified
- May 2026
- First submitted
- 28 Mar 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers due to concerns regarding patient confidentiality and institutional data use agreements
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
- ClinicalTrials.gov ID
- NCT06921148
- Acronym / sponsor ID
- 25905
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 14 Jun 2028 (estimated)
- First posted
- 10 Apr 2025 (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.
This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.
Detailed description
Medical adhesive-related skin injuries (MARSIs) affect approximately 1.5 million patients annually in the United States are one of the most overlooked complications of surgery. MARSI is a condition secondary to the use of surgical tapes, dressings, and tissue adhesives which can lead to a host of postoperative complications such as allergic contact dermatitis (ACD), wound dehiscence, surgical-site infections (SSIs), and in extreme cases sepsis. A commonly utilized surgical dressing is the Dermabond and Dermabond/Prineo system. Allergic dermatitis to these dressings is an increasingly reported adverse reaction in multiple surgical specialties; moreover, the FDA has found that approximately 75% of the adverse events reported with Dermabond/Prineo were related to ACD. These dressings are reported to produce mechanical skin tears and blisters, which can damage epidermal cells and compromise the protective skin layer, making patients susceptible to infection and other wound-related complications.
Silk bioprotein dressings have shown promise due to their biocompatibility and regenerative properties, potentially reducing MARSI compared to the Dermabond/Prineo system, which remains a standard choice for many surgical procedures. A plethora of preclinical and clinical studies have demonstrated the safety and efficacy of silk in tissue engineering, and recently only two studies have utilized this technology as a surgical site dressing demonstrating its safety and utility compared to other standard wound dressings such as Dermabond/Prineo. Despite these findings, these recent studies utilized a small cohort of patients and had a relatively diverse patient population in regard to type of surgery performed. Therefore, the comparative efficacy of Silk bioprotein dressing remains undetermined. Silk bioprotein dressings and Dermabond/Prineo are both currently used in the IU Health system as surgical wound dressings.
Double-incision mastectomy, a common procedure for female-to-male gender affirmation surgery, is a relatively standardized procedure in terms of wound dimensions, tissue dissection, and closure tension; additionally, all patients undergoing this procedure by definition will receive bilateral procedures. This uniformity allows for a unique study design where patients can serve as their own internal controls. Prior to the introduction of Silk bioprotein dressings to the IU Health/Eskenazi hospital systems, the majority of these surgical wounds were dressed with Dermabond/Prineo, whereas now it is mixed based on product availability. Our study aims to better elucidate the wound healing outcomes of Silk dressing using a patient population that are not only undergoing a fairly standardized surgical procedure, but could also serve as their own internal controls. Our decision would dress one incision with silk dressings, and the other with Dermabond/Prineo. This approach minimizes variability and imposes minimal risk, ensuring a robust comparison of outcomes between the two dressings, and will add data to the current literature on the utility of silk bioprotein dressings in surgical wound care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients who undergo the intervention will act as their own controls. Patients undergo these surgeries bilaterally, meaning one side of their chest will have the interventional dressing applied, and the other side of their chest will have the control dressing applied.
| Arm | Type | Receives |
|---|---|---|
| Sylk Wound Dressing | Experimental | Device: Sylk Wound DressingPatients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls. |
| Dermabond/Prineo Dressing | Experimental | Device: Dermabond/Prineo DressingPatients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.
- Physicians will be plastic surgeons in the IU Health system
Key exclusion criteria (7 listed)
- Patients with a history of breast cancer.
- Patients with prior history of breast surgery.
- Patients with a prior history of radiation to the chest wall/breast.
- Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).
- Patients with a history of documented allergic reaction to Dermabond/Prineo or Silk Bioprotein dressing, or any of the constituents that make up these dressings.
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 |
|---|---|---|
| Sylk Wound DressingPatients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing. | Device | Sylk Wound Dressing |
| Dermabond/Prineo DressingPatients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing. | Device | Dermabond/Prineo Dressing |
Primary outcome
Medical Adhesive-Related Skin Injury (MARSI)
Time frame: 12 weeks postoperatively
This outcome will assess the incidence and time point postoperatively of MARSIs in both dressing types (Silk and Dermabond/Prineo) used on the chest walls of patients enrolled in this study. This will be determined via physical examination and photo documentation of patient surgical incisions.
Timeing of premature removal of postoperative dressing
Time frame: 12 weeks postoperatively
This objective will the post-operative time at which dressings are removed due to adverse events and/or intrinsic properties of the dressing falling off prior to what was instructed by the operating surgeon. This will be determined by physical exam or via patient-reported outcomes
Postoperative wound infection and dehiscence
Time frame: Any time up until 12 weeks postoperatively
This objective will assess the incidence and time postoperatively of wound dehiscence or infection on the postoperative incisions of patients. This will be determined by clinical examination and documented photographs of patient's incisions.
2 secondary outcomes
Subjective wound healing outcome by patient
Time frame: Patients will have their subjective opinions evaluated 1, 2, 4, and 8-12 weeks post-operatively via phone survey
Subjective wound healing outcome of scar by blinded plastic surgeons
Time frame: 12 weeks postoperative
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers due to concerns regarding patient confidentiality and institutional data use agreements
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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.
Ivan Hadad, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sylk Wound Dressing and Dermabond/Prineo Dressing in people with Wound Healing, run by Indiana University at 1 site in United States.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Ivan Hadad, MD ((317) 944-5000, ihadad@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Adhesive-Related Skin Injury (MARSI) (time frame: 12 weeks postoperatively). The study lists 3 primary outcomes in all. 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 4 Nov 2026.