Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phalloplasty, a genitourinary surgery for transmasculine patients, reconstructs a neophallus using tissue transferred from other parts of the body to the groin. However, this technique fails to provide adequate sensation, causing regret and persistent dysphoria. Peripheral nerve regeneration is the greatest barrier to sensory recovery, given the slow rate of regrowth coupled with the negative effects of axonal degeneration. Topical application of polyethylene glycol (PEG) fuses severed axonal membranes, restoring the nerve's immediate ability to conduct electrical signals across the repair site. We hypothesize that utilizing PEG in phalloplasties will significantly improve neophallus sensation and postoperative quality of life.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• We will consider subjects over the age of 18 with a preoperative diagnosis of gender dysphoria and present for planned radial forearm free flap phalloplasty. Participants must be willing to comply with all aspects of treatment (post-operative visits) as well as the study evaluation schedule (follow-up visits up to 15 months postoperatively).

Exclusion Criteria:

• Patients will be excluded from enrollment if they have a known allergy to the study drug, a hematocrit of 54% or higher, or a history of venous thromboembolism (VTE), peripheral phlebitis, stroke, or myocardial infarction within the last 6 months.