RecruitingNot ApplicableNCT06921148

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

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


Sponsor

Indiana University

Enrollment

50 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Dermabond/Prineo Dressing and a medical device called Sylk Wound Dressing for people with wound healing. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESylk 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.

DEVICEDermabond/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

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NCT06921148


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