The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy

I
Ivan Hadad

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
50 participants needed
3 Locations

Brief description of study

What is the purpose of this study?

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be those who are already under the care of the principal investigator. All patients who present to the PI in the outpatient clinic who plan to undergo double-incision mastectomy will be approached for enrollment. The setting of enrollment will be in the outpatient clinic, where these patients will already be for pre-operative discussion and work-up. Patients may also be approached in the pre-operative waiting area the day of their surgery. All initial contact with patients will be in-person. The setting of this study will occur in the outpatient clinic of the principal investigator, as well as in the operating rooms at Eskenazi Hospital and IU Health facilities.  Additionally, recruitment of IU plastic surgeons will be conducted in-person as well.

Detailed description of study

What will happen during the study?

The patients to be enrolled are those who plan to undergo the index operation regardless of study enrollment. 

The treatment arm and control arm dressings are already utilized in clinical practice by the principal investigator. Because all patients will be undergoing a bilateral procedure, they will serve as their own controls and will receive both the treatment dressing on one side of their chest, and the control dressing on the contralateral side. The side that receives either dressing will be randomized.

The treatment and control dressings are already utilized by the principal investigator in this patient population, as well as other patient populations not studied in this protocol; the key difference beyond standard of clinical care that this study will investigate is that individual patients will be receiving both the treatment dressing and control dressing after surgery (one type on each side of chest), which is not done in clinical practice, where only one dressing type is utilized for both sides. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast reduction, Breast removal, Wound
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
•    Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator

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, immune deficiency, morbid obesity)

Updated on 15 May 2025. Study ID: SURG-IIR-25905, 25905
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