Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Not Applicable

Not yet recruiting

• Conditions: Wound Healing

• Registration Number: NCT06921148
• Lead Sponsor: Indiana University

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.

Detailed Description

Medical adhesive-related skin injuries (MARSIs) affect approximately 1.5 million patients annually in the United States are one of the most overlooked complications of surgery. MARSI is a condition secondary to the use of surgical tapes, dressings, and tissue adhesives which can lead to a host of postoperative complications such as allergic contact dermatitis (ACD), wound dehiscence, surgical-site infections (SSIs), and in extreme cases sepsis. A commonly utilized surgical dressing is the Dermabond and Dermabond/Prineo system. Allergic dermatitis to these dressings is an increasingly reported adverse reaction in multiple surgical specialties; moreover, the FDA has found that approximately 75% of the adverse events reported with Dermabond/Prineo were related to ACD. These dressings are reported to produce mechanical skin tears and blisters, which can damage epidermal cells and compromise the protective skin layer, making patients susceptible to infection and other wound-related complications.

Silk bioprotein dressings have shown promise due to their biocompatibility and regenerative properties, potentially reducing MARSI compared to the Dermabond/Prineo system, which remains a standard choice for many surgical procedures. A plethora of preclinical and clinical studies have demonstrated the safety and efficacy of silk in tissue engineering, and recently only two studies have utilized this technology as a surgical site dressing demonstrating its safety and utility compared to other standard wound dressings such as Dermabond/Prineo. Despite these findings, these recent studies utilized a small cohort of patients and had a relatively diverse patient population in regard to type of surgery performed. Therefore, the comparative efficacy of Silk bioprotein dressing remains undetermined. Silk bioprotein dressings and Dermabond/Prineo are both currently used in the IU Health system as surgical wound dressings.

Double-incision mastectomy, a common procedure for female-to-male gender affirmation surgery, is a relatively standardized procedure in terms of wound dimensions, tissue dissection, and closure tension; additionally, all patients undergoing this procedure by definition will receive bilateral procedures. This uniformity allows for a unique study design where patients can serve as their own internal controls. Prior to the introduction of Silk bioprotein dressings to the IU Health/Eskenazi hospital systems, the majority of these surgical wounds were dressed with Dermabond/Prineo, whereas now it is mixed based on product availability. Our study aims to better elucidate the wound healing outcomes of Silk dressing using a patient population that are not only undergoing a fairly standardized surgical procedure, but could also serve as their own internal controls. Our decision would dress one incision with silk dressings, and the other with Dermabond/Prineo. This approach minimizes variability and imposes minimal risk, ensuring a robust comparison of outcomes between the two dressings, and will add data to the current literature on the utility of silk bioprotein dressings in surgical wound care.

Study Timeline

• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Study Start: 2025-04-30
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wound Healing	1 year	The primary objective of this study is to examine the wound healing outcomes (MARSIs, post-operative time at which dressing was removed due to adverse events and/or intrinsic properties of the dressing falling off, wound dehiscence, infection, scar burden and outcome, patient-reported symptoms) reported by patients and providers comparing Silk bioprotein dressing to Dermabond/Prineo dressing on patients undergoing bilateral double incision mastectomies for female to male gender affirmation surgery. Wound healing will be determined using an investigator administered custom questionnaire, of which the parameters were created with the guidance of the Joint Task Force on Practice Parameters for Allergy and Immunology for Contact Dermatitis. This questionnaire will assess subjective outcomes of rash/ discomfort/ itchiness/wound healing from patients \[rated on scale of 1 to 5; 1 being no concerns, and 5 being high concerns\].