Silk bioprotein wound dressing for double‑incision mastectomy
The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
This project will test whether a silk bioprotein dressing reduces adhesive‑related skin injuries and other wound problems compared with Dermabond/Prineo in adults having double‑incision mastectomy for gender‑affirming surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06921148 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) scheduled for double‑incision bilateral mastectomy for female‑to‑male gender‑affirmation at Indiana University Health who do not meet exclusion criteria.
Not a fit: Patients with prior breast surgery or chest radiation, active conditions that impair wound healing, or known allergies to the dressings are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, the silk dressing could reduce adhesive‑related skin injuries and other wound complications, improving healing, comfort, and cosmetic outcomes after double‑incision mastectomy.
How similar studies have performed: Silk bioprotein has supportive preclinical and clinical data in tissue engineering, and a small number of prior clinical reports have shown safety and potential usefulness as a surgical dressing, but its use for this procedure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.