Polyethylene-glycol Assisted Nerve Repair in Phalloplasty
Gender Dysphoria
About this trial
This is an interventional treatment trial for Gender Dysphoria focused on measuring Phalloplasty
Eligibility Criteria
Inclusion Criteria: over the age of 18 preoperative diagnosis of gender dysphoria and present for planned radial forearm free flap phalloplasty willing to comply with all aspects of treatment as well as the study evaluation schedule Exclusion Criteria: a known allergy to the study drug a hematocrit of 54% or higher a history of venous thromboembolism (VTE), peripheral phlebitis, stroke, or myocardial infarction within the last 6 months.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control (No Intervention)
Experimental
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.
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).