Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Launched by INDIANA UNIVERSITY · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a special material called Silk bioprotein can be as a dressing for wounds after a double-incision mastectomy, which is a type of surgery some transgender men may choose for gender affirmation. Silk bioprotein is already approved for use and is available for patients after surgery. The goal is to see if this dressing can help improve healing for patients undergoing this specific surgery.

To participate in the study, you need to be over 18 years old and having a double-incision mastectomy with plastic surgeons from the IU Health system. However, there are some people who cannot join, such as those with a history of breast cancer or certain medical conditions that might affect healing. If you qualify and decide to take part, you’ll receive care from experienced surgeons and have the opportunity to help researchers learn more about wound healing in this context.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.