Nerve Repair with Polyethylene Glycol for Gender Dysphoria
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Vanderbilt University Medical Center
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests whether using a special substance during surgery can improve sensation in the new penis for patients. The substance helps nerves heal quickly, aiming to enhance the quality of life by providing better sensory outcomes.
Eligibility Criteria
This trial is for adults over 18 with gender dysphoria who are undergoing phalloplasty using tissue from their forearm. They must be willing to follow treatment and study evaluations for up to 15 months post-surgery. It's not for those allergic to PEG, with high hematocrit levels, or a history of blood clots, vein inflammation, recent stroke or heart attack.Treatment Details
The trial tests if applying polyethylene glycol (PEG) during phalloplasty can improve sensation in the newly constructed neophallus. The goal is to see if PEG helps nerves heal better after surgery, potentially enhancing quality of life.
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
For the experimental group, after obtaining hemostasis, prior to neurorrhaphy, the operative field will be irrigated with calcium-free Plasmalyte A® (Baxter: Deerfield, IL) throughout the neurorrhaphy. At this point, the nerves will be repaired using standard suture neurorrhaphy techniques. Subsequently, approximately 1 or 2 drops of 5mg/ml (0.5%) methylene blue in sterile water solution are applied to the trimmed nerve endings. Then, approximately 2 ccs of a 190 mM solution of 50% PEG 3.35 kD in sterile water will be irrigated onto the neurorrhaphy site and the surgeon will wait one minute prior to continuing. Following this, the repaired nerve will be irrigated with calcium-containing Lactated Ringers (Hospira; Lake Forest, IL).
Group II: Control (No Intervention)Active Control1 Intervention
For the control groups, epineural repair will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
Loading ...
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor