Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
Recruiting now · Not applicable
Conditions studied: Wound Healing
In brief
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.
Key facts
- Study ID
- NCT06921148
- Run by
- Indiana University
- People needed
- 50
- Starts
- 2025-04-30
- Expected to finish
- 2028-06-14
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Indiana University Health — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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