Status:
RECRUITING
Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
Lead Sponsor:
Indiana University
Conditions:
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
NA
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 fem...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06921148
Start Date
April 30 2025
End Date
June 14 2026
Last Update
June 4 2025
Active Locations (1)
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1
Indiana University Health
Indianapolis, Indiana, United States, 46202