ABSTRACT
Objective To evaluate the safety and efficacy of the human acellular nerve allograft (hANG)for nerve repair in the clinical setting,and report the early outcomes of bridging digital nerve defect with the hANG. Methods Four patients with 5 digital nerve injuries were included in this pilot study.The nerves defect ranged from 10-20 mm and were bridged with the hANG(manufactured by Zhongda Medical Equipment Co.,Ltd,Guangzhou,China).Four digital nerve acute injuries in 3 patients were repaired with hANG primarily,while the nerve in another patient was reconstructed secondarily.The procedure was performed under a 10-manifying operating microscope.The nerve stumps were debrided until the normal fascicles could be seen.hANG was inserted between the proximal and distal stumps and end-to-end neurorrhaphy was performed with 9-0 sutures.Postoperative cares included dressing change and administration of antibiotics.No immunosuppressants had been used.The follow-up time ranged from 1 to 3 months.The wound and blood sample were examined for the safety of hANG.The nerve function Wag evaluated according to the scoring system proposed by the Nerve Injuries Committee of the British Medical Research Council. Results All wounds healed primarily.The adverse effects,such as rejection,allergy,infection,and toxicity to the liver and kidney were absent.The results of blood biochemistry test were within the normal range.The injured nerve achieved good functional recovery.In 2 cages,the 2 point discrimination(2PD)was 8mm(S3~+,excellent). Conclusion Based on the short term follow-up,using hANG to repair digital nerve defect as long as 20mm was safe,and the nerve functional recovery is pretty good.