Recruiting

Silk Bioprotein

Sponsor:

Indiana University

Code:

NCT06921148

Conditions

Wound Healing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sylk Wound Dressing

Dermabond/Prineo Dressing

Study Details

Brief 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.

Conditions

Wound Healing

Study ID

NCT06921148

Start date

Apr 30, 2025

Status verified date

May, 2026

Completion date

Jun 14, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sylk Wound Dressing

Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.

experimental: Dermabond/Prineo Dressing

Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.

Interventions

Sylk 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.

Dermabond/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.

Primary outcome measure

  • Medical Adhesive-Related Skin Injury (MARSI) [ Time Frame: 12 weeks postoperatively ]
  • Timeing of premature removal of postoperative dressing [ Time Frame: 12 weeks postoperatively ]
  • Postoperative wound infection and dehiscence [ Time Frame: Any time up until 12 weeks postoperatively ]

Central Contacts and Locations

Central contacts

Ivan Hadad, MD

(317) 944-5000ihadad@iu.edu

Parhom Towfighi, MD

(317) 944-5000ptowfigh@iu.edu

Locations

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Ivan Hadad, MD

(317) 944-5000ihadad@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Jun 9, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-09.