RECRUITING

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

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Conditions

Wound Healing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-30
Study Completion:2026-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06921148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.
  2. * Physicians will be plastic surgeons in the IU Health system
  1. * Patients with a history of breast cancer.
  2. * Patients with prior history of breast surgery.
  3. * Patients with a prior history of radiation to the chest wall/breast.
  4. * Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).
  5. * 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.
  6. * 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.
  7. * Physicians not in the IU Health system will not be included.

Contacts and Locations

Study Contact

Ivan Hadad, MD
CONTACT
(317) 944-5000
ihadad@iu.edu
Parhom Towfighi, MD
CONTACT
(317) 944-5000
ptowfigh@iu.edu

Principal Investigator

Ivan Hadad, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University Health
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Ivan Hadad, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2026-06-14

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2026-06-14

Terms related to this study

Additional Relevant MeSH Terms

  • Wound Healing