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Efficacy and Safety of Sodium Hyaluronate with 1,4-Butanediol Diglycidyl Ether Compared to Sodium Carboxymethylcellulose in Preventing Adhesion Formation after Lumbar Discectomy

 Gyu Yeul Ji  ;  Chang Hyun Oh  ;  Byung Gwan Moon  ;  Seong Yi  ;  In Bo Han  ;  Dong Hwa Heo  ;  Ki-Tack Kim  ;  Dong Ah Shin  ;  Keung Nyun Kim 
 Korean Journal of Spine, Vol.12(2) : 41-47, 2015 
Journal Title
 Korean Journal of Spine 
Issue Date
Anti-adhesion ; Scar formation ; Lumbar discectomy ; Sodium hyaluronate ; 1,4-butanediol diglycidyl ether (BDDE) ; Sodium carboxymethylcellulose (CMC)
OBJECTIVE: Epidural injection of hyaluronic acid may prevent adhesion formation after spine surgery, but the compounds used to stabilize hyaluronidase could interfere with its anti-adhesion effects. The present study was conducted as a clinical trial to evaluate the efficacy and safety of an experimental medical gel in preventing adhesion formation. METHODS: This study was designed as a multicenter, randomized, double-blind, and comparative controlled clinical trial with an observation period of 6 weeks. Subjects were randomly assigned into two groups: group A with sodium hyaluronate + 1,4-butanediol diglycidyl ether (BDDE) and group B with sodium hyaluronate + sodium carboxymethylcellulose (CMC). Visual analogue scale (VAS) of back and leg pain and the Oswestry disability index (ODI) and scar score ratings were assessed after surgery. RESULTS: Mean scar grade was 2.37±1.13 in group A and 2.75±0.97 in group B, a statistically significant difference (p=0.012). VAS of back and leg pain and ODI scores decreased significantly from baseline to 3 and 6 weeks postoperatively in both groups (p<0.001). However, VAS and ODI scores were not statistically different between groups A and B at baseline or at 3 and 6 weeks after operation (p>0.3). The number of adverse reactions related to the anti-adhesion gels was not statistically different (p=0.569), but subsequent analysis of nervous adverse reactions showed group B was superior with a statistically difference (p=0.027). CONCLUSION: Sodium hyaluronate with BDDE demonstrated similar anti-adhesion properties to sodium hyaluronate with CMC. But, care should be used to nervous adverse reactions by using sodium hyaluronate with BDDE.
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1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Keung Nyun(김긍년)
Shin, Dong Ah(신동아) ORCID logo https://orcid.org/0000-0002-5225-4083
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