NCT06921148 · Indiana University
Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Sylk Wound Dressing
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.
DEVICE
Dermabond/Prineo Dressing
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Indianapolis, Indiana
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations