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Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

Primary Purpose

Gender Dysphoria

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol 3350
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gender Dysphoria focused on measuring Phalloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

No Intervention

Experimental

Arm Label

Control (No Intervention)

Experimental

Arm Description

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).

Outcomes

Primary Outcome Measures

Medical Research Council Classification (MRCC)
measures sensory recovery

Secondary Outcome Measures

Vanderbilt Mini-PROM for Gender-Affirming Surgery(VMP-G)
This questionnaire measures psychosocial well-being and resolution of gender-dysphoria
Sexual Functioning and Sensation Questionnaire
measures sexual function and subjective/erogenous sensation

Full Information

First Posted
June 1, 2023
Last Updated
September 7, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05897086
Brief Title
Polyethylene-glycol Assisted Nerve Repair in Phalloplasty
Official Title
Nerve Repair Using Hydrophilic Polymers to Improve Tactile and Erogenous Neophallus Sensation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
With more than 1.6 million transgender and nonbinary (TGNB) individuals in the United States, the investigators have witnessed an exponential increase in the number of gender-affirming surgeries performed in the last 2 decades. Of the affirming surgical spectrum, "bottom" genitourinary surgeries remain the most challenging. Specifically, phalloplasty is a masculinizing surgery for neophallus creation using free tissue transfer from other parts of the body and microvascular techniques for nerve and vessel reattachment. In radial forearm free flap (RFFF) phalloplasty, nerves from the forearm are harvested with the flap and sutured to nerves in the groin to provide postoperative sensation in the neophallus. Despite transmasculine patients ranking sensation as one of their top priorities, standard nerve coaptations performed in phalloplasty fail to provide consistent sensation with scarce dedicated research aimed at enhancing neophallus sensory outcomes. Without scientific advances, phalloplasty will remain far from perfect, negatively affecting patients' sexual health, causing dissatisfaction, and increasing the risk of surgical regret and persistent dysphoria. Peripheral nerve regeneration remains the limiting factor for ideal sensory recovery due to the slow and inconsistent rates of regeneration, and the negative effects of axonal degeneration that occurs post-injury. The investigators advocate for using polyethylene glycol as a "fusogen" to achieve nerve fusion in peripheral nerve coaptations. Polyethylene glycol (PEG) is a hydrophilic compound that enhances the fusion of the lipid bilayer membrane of severed axons, restoring the nerve's immediate ability to conduct electrical signals across the repair site. The investigators have conducted extensive mammalian and preliminary human studies using our novel PEG-fusion protocol for nerve coaptations. In both ex-vivo and in-vivo studies in rats with severed sciatic nerves, PEG-assisted nerve coaptation restored morphological continuity and led to a remarkable early improvement in functional outcomes. In the first human PEG fusion of injured digital nerves performed by our team, the investigators saw rapid nerve recovery and early functional outcomes as early as one week. Based on the investigator's experience with PEG fusion, the investigators will be conducting a randomized clinical trial to test the efficacy of PEG-assisted nerve coaptation in achieving superior neophallus sensory function following phalloplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria
Keywords
Phalloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (No Intervention)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol 3350
Intervention Description
Topical irrigation with approximately 2 ccs of a 190 mM solution of 50% PEG 3.35 kD in sterile water
Primary Outcome Measure Information:
Title
Medical Research Council Classification (MRCC)
Description
measures sensory recovery
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Vanderbilt Mini-PROM for Gender-Affirming Surgery(VMP-G)
Description
This questionnaire measures psychosocial well-being and resolution of gender-dysphoria
Time Frame
15 months
Title
Sexual Functioning and Sensation Questionnaire
Description
measures sexual function and subjective/erogenous sensation
Time Frame
15 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Transmasculine
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Thayer, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

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