Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy
ConditionWound Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Sylk Wound Dressing
- Dermabond/Prineo Dressing
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov