Nerve Repair with Polyethylene Glycol for Gender Dysphoria

Overseen By Patrick Assi, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Allergy to study drug, VTE, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Phalloplasty with Polyethylene Glycol for Gender Dysphoria?

Research shows that polyethylene glycol (PEG) can help repair nerves by fusing severed nerve endings, which has been effective in animal models for restoring nerve function after injury. This suggests that PEG might improve nerve repair outcomes in surgeries like phalloplasty. ^{1 2 3 4 5}

Is polyethylene glycol safe for nerve repair in humans?

Polyethylene glycol (PEG) has been studied in animal models for nerve repair, showing it can help reconnect damaged nerves. However, some studies suggest that high concentrations of PEG might affect nerve function, but these concentrations are higher than those typically used in clinical settings. ^{2 4 6 7 8}

How is the treatment with Polyethylene Glycol for nerve repair in gender dysphoria unique?

This treatment is unique because it uses Polyethylene Glycol (PEG) to potentially fuse nerve endings quickly, which could enhance nerve repair compared to traditional methods that rely on slow nerve regeneration. PEG acts as a 'nerve glue' to immediately seal and reconnect nerve membranes, offering a novel approach to nerve repair. ^{1 4 5 9 10}

Research Team

Wesley Thayer, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

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.

Inclusion Criteria

I am diagnosed with gender dysphoria and planning to undergo forearm flap surgery for phalloplasty.

I am over 18 years old.

I am willing to follow all treatment and study check-up plans.

Exclusion Criteria

Patients with a hematocrit of 54% or higher

Patients with a known allergy to the study drug

I have had a blood clot, stroke, or heart attack in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo phalloplasty with nerve repair using either standard or PEG-assisted techniques

1-2 weeks

Inpatient stay for surgery and initial recovery

Follow-up

Participants are monitored for sensory recovery and quality of life improvements

15 months

Regular follow-up visits for assessments

Treatment Details

Interventions

• Phalloplasty
• Polyethylene Glycol 3350
• Polyethylene-glycol Assisted Nerve Repair
• Postoperative Quality of Life

Trial Overview 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.

Participant Groups

Group I: Experimental Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

In a study involving 29 rats with sciatic nerve repairs, PEG hydrogel showed a significant reduction in scar tissue formation compared to fibrin glue, suggesting it may promote better healing conditions.

Both PEG hydrogel and fibrin glue resulted in similar muscle strength recovery after 10 weeks, indicating that PEG hydrogel is as effective as fibrin glue for nerve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary investigation of a polyethylene glycol hydrogel "nerve glue". Isaacs, J., Klumb, I., McDaniel, C.[2021]

In a study involving male Lewis rats with transected median nerves, polyethylene glycol (PEG) fusion significantly improved functional recovery compared to standard suture repair, with grip strength recovery reaching 77.2% by postoperative day 98 in the PEG group.

Both PEG and PEG combined with methylene blue (PEG+MB) led to a quicker return of nerve function, with grip strength recovery observed as early as postoperative day 3.8, while the standard repair group showed minimal recovery until day 21.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Fusion Restores Axonal Continuity and Improves Return of Function in a Rat Median Nerve Denervation Model. Frost, C., Salous, A., Ketheeswaran, S., et al.[2023]

In a rat model of sciatic nerve injury, polyethylene glycol (PEG) was found to rapidly restore axonal continuity within minutes, showing significant improvements in nerve function over 12 weeks compared to traditional repair methods.

PEG treatment led to a notable increase in motor axon counts and restored behavioral functions by up to 50%, suggesting it could greatly enhance the management of traumatic peripheral nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Enhancement of Nerve Function Using a Novel Axonal Fusion Device After Neurotmesis. Riley, DC., Boyer, RB., Deister, CA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary investigation of a polyethylene glycol hydrogel "nerve glue". [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Fusion Restores Axonal Continuity and Improves Return of Function in a Rat Median Nerve Denervation Model. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Hydrophilic polymers enhance early functional outcomes after nerve autografting. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Nerve Fusion Technique With Polyethylene Glycol in a Delayed Setting After Nerve Injury. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Cellular engineering: molecular repair of membranes to rescue cells of the damaged nervous system. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Polyethylene glycol rapidly restores physiological functions in damaged sciatic nerves of guinea pigs. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Polyethylene glycol restores axonal conduction after corpus callosum transection. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of polyethylene glycol on mammalian nerve impulses. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Immediate Enhancement of Nerve Function Using a Novel Axonal Fusion Device After Neurotmesis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Polyethylene glycol protects injured neuronal mitochondria. [2018]