title: Efficacy and Safety of Sodium Hyaluronate with 1,4-Butanediol Diglycidyl Ether Compared to Sodium Carboxymethylcellulose in Preventing Adhesion Formation after Lumbar Discectomy.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea. ; Department of Neurosurgery, Guro Teun Teun Hospital, Seoul, Korea.
authors.forename: Gyu Yeul
authors.initials: GY
authors.lastname: Ji
authors.affiliation: Department of Neurosurgery, Guro Teun Teun Hospital, Seoul, Korea.
authors.forename: Chang Hyun
authors.initials: CH
authors.lastname: Oh
authors.affiliation: Department of Neurosurgery, Eulji Hospital, Eulji University College of Medicine, Seoul, Korea.
authors.forename: Byung Gwan
authors.initials: BG
authors.lastname: Moon
authors.affiliation: Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Seong
authors.initials: S
authors.lastname: Yi
authors.affiliation: Department of Neurosurgery, Bundang CHA Medical Center, CHA University College of Medicine, Sungnam, Korea.
authors.forename: In Bo
authors.initials: IB
authors.lastname: Han
authors.affiliation: Department of Neurosurgery, The Leon Wiltse Memorial Hospital, Suwon, Korea.
authors.forename: Dong Hwa
authors.initials: DH
authors.lastname: Heo
authors.affiliation: Department of Orthopedic Surgery, Kyung Hee University College of Medicine, Seoul, Korea.
authors.forename: Ki-Tack
authors.initials: KT
authors.lastname: Kim
authors.affiliation: Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Dong Ah
authors.initials: DA
authors.lastname: Shin
authors.affiliation: Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Keung Nyun
authors.initials: KN
authors.lastname: Kim
keywords: 1,4-butanediol diglycidyl ether (BDDE); Anti-adhesion; Lumbar discectomy; Scar formation; Sodium carboxymethylcellulose (CMC); Sodium hyaluronate