The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Indiana
Indiana University Health
RECRUITING
Indianapolis
Contact Information
Primary
Ivan Hadad, MD
ihadad@iu.edu
(317) 944-5000
Backup
Parhom Towfighi, MD
ptowfigh@iu.edu
(317) 944-5000
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2026-06-14
Participants
Target number of participants: 50
Treatments
Experimental: Sylk Wound Dressing
Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.
Experimental: Dermabond/Prineo Dressing
Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.
Related Therapeutic Areas
Sponsors
Leads: Indiana University