Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

NCT06921148 | Recruiting FDA Device

• 1 other identifier: 25905
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Medical Adhesive-Related Skin Injury (MARSI)

  This outcome will assess the incidence and time point postoperatively of MARSIs in both dressing types (Silk and Dermabond/Prineo) used on the chest walls of patients enrolled in this study. This will be determined via physical examination and photo documentation of patient surgical incisions.

  12 weeks postoperatively

• Timeing of premature removal of postoperative dressing

  This objective will the post-operative time at which dressings are removed due to adverse events and/or intrinsic properties of the dressing falling off prior to what was instructed by the operating surgeon. This will be determined by physical exam or via patient-reported outcomes

  12 weeks postoperatively

• Postoperative wound infection and dehiscence

  This objective will assess the incidence and time postoperatively of wound dehiscence or infection on the postoperative incisions of patients. This will be determined by clinical examination and documented photographs of patient's incisions.

  Any time up until 12 weeks postoperatively

Secondary Outcomes (2)

• Subjective wound healing outcome by patient

  Patients will have their subjective opinions evaluated 1, 2, 4, and 8-12 weeks post-operatively via phone survey

• Subjective wound healing outcome of scar by blinded plastic surgeons

  12 weeks postoperative

Study Arms (2)

Sylk Wound Dressing

EXPERIMENTAL

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.

Device: Sylk Wound Dressing

Dermabond/Prineo Dressing

EXPERIMENTAL

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.

Device: Dermabond/Prineo Dressing

Interventions

Sylk Wound Dressing DEVICE

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.

Sylk Wound Dressing

Dermabond/Prineo Dressing DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Study Officials

• Ivan Hadad, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Hadad, MD

CONTACT

(317) 944-5000; ihadad@iu.edu

Parhom Towfighi, MD

CONTACT

(317) 944-5000; ptowfigh@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Model Details: All patients who undergo the intervention will act as their own controls. Patients undergo these surgeries bilaterally, meaning one side of their chest will have the interventional dressing applied, and the other side of their chest will have the control dressing applied.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 10, 2025
• Study Start: April 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)