Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT05897086
PHASE2/PHASE3

Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Official title: Nerve Repair Using Hydrophilic Polymers to Improve Tactile and Erogenous Neophallus Sensation

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-08-01

Completion Date

2029-12-01

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

DRUG

Polyethylene Glycol 3350

Topical irrigation with approximately 2 ccs of a 190 mM solution of 50% PEG 3.35 kD in sterile water

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States