NCT06921148 Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
| NCT ID | NCT06921148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Wound Healing |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-30 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Ivan Hadad, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06921148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Healing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921148 currently recruiting?
Yes, NCT06921148 is actively recruiting participants. Contact the research team at ihadad@iu.edu for enrollment information.
Where is the NCT06921148 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06921148 clinical trial?
NCT06921148 is sponsored by Indiana University. The principal investigator is Ivan Hadad, MD at Indiana University. The trial plans to enroll 50 participants.