Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Mar 8, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion," is investigating a new approach to help patients recover from certain types of arm and hand nerve injuries. Specifically, the study is looking at whether a substance called polyethylene glycol (PEG) can safely assist in repairing damaged nerves when used during surgery. While PEG has been used safely in other medical procedures, this trial aims to find out if it can effectively promote nerve healing in humans, especially for patients who have experienced complete nerve injuries in the upper arm or hand.

To participate in this study, individuals must be between 18 and 80 years old and have sustained a complete peripheral nerve injury from an accident within 48 hours. The injury should affect one of the major nerves in the arm, such as the axillary or median nerve, and involve both sensory (feeling) and motor (movement) functions. Participants will receive treatment involving PEG fusion, and their recovery will be monitored to assess improvements in feeling and movement. This trial is currently recruiting, and results will help determine if further studies are needed to explore PEG's effectiveness in nerve repair.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-80
• • 2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
• • 3. Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist
• • 4. Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).
• Exclusion Criteria:
• • 1. Patients beginning surgery within hours after injury.
• • 2. Injury to the brachial plexus nerves
• • 3. Injury to the nerves distal to the distal flexion crease of the wrist
• • 4. Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).
• • 5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
• • 6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
• • 7. Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
• • 8. Not expected to survive the next 30 days due to their injuries/health condition.
• • 9. The subject has a known allergy to polyethylene glycol (PEG).
• • 10. If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \> 10 mm on the CL side during baseline period, the subject is a screen failure.
• • 11. The subject is pregnant and/or is breastfeeding.
• • 12. The subject has a significant medical comorbidity precluding immediate repair.
• • 13. The subject is not able to strictly adhere to the rules of the current clinical protocol.