Silk bioprotein wound dressing for double‑incision mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing double‑incision bilateral mastectomy for female‑to‑male gender‑affirming surgery at Indiana University Health will receive either a silk bioprotein dressing (Sylk) or the standard Dermabond/Prineo dressing applied to their surgical incisions. Clinical staff will monitor participants during routine postoperative visits for adhesive‑related skin injuries, wound dehiscence, surgical‑site infection, and healing outcomes, and record any adverse reactions. Key exclusion criteria include prior breast surgery or radiation, a history of breast cancer, significant comorbidities that impair healing, or known allergies to either dressing. The trial compares the incidence and severity of skin reactions and wound complications between the two dressing groups to determine whether silk offers a safer alternative.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Health
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Ivan Hadad, MD — Indiana University
• Study coordinator: Ivan Hadad, MD
• Email: ihadad@iu.edu
• Phone: (317) 944-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.