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

Wound Healing

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

Inclusion Criteria2

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 Criteria7

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.

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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