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RECRUITING
NCT06921148
NA

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Official title: The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-30

Completion Date

2026-06-14

Last Updated

2025-06-04

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Sylk Wound Dressing

Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.

DEVICE

Dermabond/Prineo Dressing

Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.

Locations (1)

Indiana University Health

Indianapolis, Indiana, United States