A Sutureless Approach to Nerve Repair: Results From a Clinical Study in Digital Nerves

Purpose: Traditional microsurgical suture neurorrhaphy presents challenges such as fascicular trauma, scar formation, and variability in repair quality. This clinical study evaluates the safety and efficacy of a bioresorbable poly(glycerol sebacate) acrylate (PGSA) polymer-assisted device in digital nerve repair without sutures. Methods: A single-arm clinical trial enrolled 12 patients with digital nerve injuries at two centers. The repair involved securing severed nerve ends within a 3-dimensional printed PGSA coaptation chamber using a light-activated PGSA polymer. Patients were prospectively followed for 12 months with assessments including pain (visual analog scale pain score), sensory recovery (Semmes-Weinstein Monofilament and two-point discrimination), patient-reported outcomes (Impact of Hand Nerve Disorders Questionnaire v2.0), and high-resolution ultrasound imaging. Results: At 12 months, 10 patients who completed the study had a Semmes-Weinstein Monofilament score of 0.4 ("diminished light touch") or better, with 100% achieving "Good" (S3+) or "Excellent" (S4) two-point discrimination scores. No patient reported pain at 12 months, and no device-related complications were recorded. Ultrasound confirmed intact repairs with no neuroma formation. All patients returned to work at a median time of 41.5 days. Conclusions: Results from this study support the concept of sutureless repair of severed digital nerves using the PGSA polymer-assisted coaptation device by demonstrating that the PGSA polymer-assisted coaptation is safe, effective, and may be considered as an option for nerve approximation. Clinical relevance: These findings support the potential for broader clinical applications of polymer-assisted sutureless nerve repair.