PMID- 23436764
OWN - NLM
STAT- MEDLINE
DCOM- 20151215
LR  - 20150330
IS  - 1932-7005 (Electronic)
IS  - 1932-6254 (Linking)
VI  - 9
IP  - 3
DP  - 2015 Mar
TI  - Safety and efficacy evaluation of a human acellular nerve graft as a digital 
      nerve scaffold: a prospective, multicentre controlled clinical trial.
PG  - 286-95
LID - 10.1002/term.1707 [doi]
AB  - This study developed a human acellular nerve graft (hANG) as an alternative to 
      autogenous nerve and reports on its safety and efficacy. There were two groups 
      comprised of 72 patients that received digital nerve repair with hANG (test) and 
      81 that received conventional direct tension-free suture repair of the nerve 
      defect (control). The efficacy of the treatment was evaluated by static 2-point 
      discrimination (s2PD) and Semmes-Weinstein monofilament testing. Safety was 
      evaluated by local wound response and laboratory testing. Mean age of patients in 
      the test group was 33.0 +/- 11.1 years (range 18-61 years) and in the control group 
      36.9 +/- 13.4 years (range 15-77 years) (p = 0.0470). Mean time from injury to 
      repair in the test group was 23.7 +/- 52 days (range 0-200 days) and in the control 
      group 1.5 +/- 10.4 days (range 0-91 days) (p = 0.0005). Mean length of nerve graft 
      was 1.80 +/- 0.82 cm (range 1-5 cm). All surgeries were performed successfully and 
      without complications. The excellent and good rate of s2PD in the test group was 
      65.28% and 95% CI was 51.98-78.93%. s2PD in the test group improved over time and 
      average distance was 12.81 +/- 5.99 mm at 6 months postoperatively. No serious 
      adverse or product-related events were reported. These results indicate that hANG 
      is a safe and effective for the repair of nerve defects of 1-5 cm in size.
CI  - (c) 2015 The Authors. Journal of Tissue Engineering and Regenerative Medicine 
      published by John Wiley & Sons, Ltd.
FAU - He, Bo
AU  - He B
AD  - Department of Orthopaedic and Microsurgery, The First Affiliated Hospital of Sun 
      Yat-sen University, No. 58 Zhongshan Road 2, Guangzhou, 510080, China.
FAU - Zhu, Qingtang
AU  - Zhu Q
FAU - Chai, Yimin
AU  - Chai Y
FAU - Ding, Xiaoheng
AU  - Ding X
FAU - Tang, Juyu
AU  - Tang J
FAU - Gu, Liqiang
AU  - Gu L
FAU - Xiang, Jianping
AU  - Xiang J
FAU - Yang, Yuexiong
AU  - Yang Y
FAU - Zhu, Jiakai
AU  - Zhu J
FAU - Liu, Xiaolin
AU  - Liu X
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130225
PL  - England
TA  - J Tissue Eng Regen Med
JT  - Journal of tissue engineering and regenerative medicine
JID - 101308490
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Middle Aged
MH  - Peripheral Nerve Injuries/pathology/*therapy
MH  - Safety
MH  - *Tissue Scaffolds
OTO - NOTNLM
OT  - allogenic nerve
OT  - digital nerve
OT  - extracellular matrix
OT  - nerve regeneration
OT  - nerve transplantation
OT  - tissue engineering
EDAT- 2013/02/26 06:00
MHDA- 2015/12/17 06:00
CRDT- 2013/02/26 06:00
PHST- 2012/05/17 00:00 [received]
PHST- 2012/11/25 00:00 [revised]
PHST- 2012/12/20 00:00 [accepted]
PHST- 2013/02/26 06:00 [entrez]
PHST- 2013/02/26 06:00 [pubmed]
PHST- 2015/12/17 06:00 [medline]
AID - 10.1002/term.1707 [doi]
PST - ppublish
SO  - J Tissue Eng Regen Med. 2015 Mar;9(3):286-95. doi: 10.1002/term.1707. Epub 2013 
      Feb 25.