drugset / Trial / NCT05897086

Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

NCT05897086

Phase 2/3 Enrolling by invitation 30 enrolled Vanderbilt University Medical Center
RandomizedParallel-groupDouble-blindTreatment

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. The investigators hypothesize that utilizing PEG in phalloplasties will significantly improve neophallus sensation and postoperative quality of life.

Timeline

Start
2023-08-01
Primary completion
2028-12-30
Completion
2029-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject polyethylene glycol Other / unclassified 2 ml Topical
Subject polyethylene glycol Other / unclassified 50 % Topical

Indications

No indication recorded.