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Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
Recruiting
The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Sylk Wound Dressing (device)
- Dermabond/Prineo Dressing (device)
Sponsor: Indiana University · Participants: 50 · Started: Apr 30, 2025
Contact the study team
- Ivan Hadad, MD · Phone: (317) 944-5000
- Parhom Towfighi, MD · Phone: (317) 944-5000
Official record on ClinicalTrials.gov — NCT06921148
Locations in the U.S.
| Indiana | Indiana University Health, Indianapolis |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.