Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 19, 2019

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2028

Conditions
Peripheral Nerve Injury
Interventions
DRUG

Polyethylene glycol (PEG)

For the control groups, epineural repair or interposition grafting 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, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon.

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER