Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06921148

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Led by Indiana University · Updated on 2025-06-04

50

Participants Needed

1

Research Sites

58 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Indiana University Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

I

Ivan Hadad, MD

CONTACT

P

Parhom Towfighi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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