Clinical trial NCT06921148: Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
Official title: The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Healing
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Medical Adhesive-Related Skin Injury (MARSI)
timeFrame: 12 weeks postoperatively
measure: Timeing of premature removal of postoperative dressing
timeFrame: 12 weeks postoperatively
measure: Postoperative wound infection and dehiscence
timeFrame: Any time up until 12 weeks postoperatively
Secondary outcomes:
measure: Subjective wound healing outcome by patient
timeFrame: Patients will have their subjective opinions evaluated 1, 2, 4, and 8-12 weeks post-operatively via phone survey
measure: Subjective wound healing outcome of scar by blinded plastic surgeons
timeFrame: 12 weeks postoperative
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Ivan Hadad, MD
role: PRINCIPAL_INVESTIGATOR
References: