Efficacy and Safety of Sodium Hyaluronate with 1,4-Butanediol Diglycidyl Ether Compared to Sodium Carboxymethylcellulose in Preventing Adhesion Formation after Lumbar Discectomy
نویسندگان
چکیده
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.
منابع مشابه
Evaluation of MC3T3 Cells Proliferation and Drug Release Study from Sodium Hyaluronate-1,4-butanediol Diglycidyl Ether Patterned Gel
A pattern gel has been fabricated using sodium hyaluronate (HA) and 1,4-butanediol diglycidyl ether (BDDGE) through the micro-molding technique. The cellular behavior of osteoblast cells (MC3T3) in the presence and absence of dimethyloxalylglycine (DMOG) and sodium borate (NaB) in the pattern gel (HA-BDDGE) has been evaluated for its potential application in bone regeneration. The Fourier trans...
متن کاملSafety and Efficacy of Sodium Hyaluronate Gel and Chitosan in Preventing Postoperative Peristomal Adhesions After Defunctioning Enterostomy
Peristomal adhesions complicate closure of defunctioning enterostomy. The efficacy and safety of sodium hyaluronate gel and chitosan in preventing postoperative adhesion have not been extensively studied. This study aims to evaluate the safety and efficacy of sodium hyaluronate gel and chitosan in the prevention of postoperative peristomal adhesions.This was a prospective randomized controlled ...
متن کاملMeta-Analysis of the Effects of Adhesion Barriers on Adhesion Formation in the Horse.
OBJECTIVE To determine the efficacy of adhesion barriers in horses using quantitative statistical analysis. STUDY DESIGN Meta-analytical review. METHODS A search using PubMed/MEDLINE and Google Scholar was performed, followed by secondary searches of veterinary trade journals, bibliographies of relevant articles, manufacturer websites, and technical reference guides. Randomized experimental...
متن کاملComparison of hyaluronate/carboxymethylcellulose membrane and melatonin for prevention of adhesion formation in a rat model.
BACKGROUND To investigate the effectiveness of melatonin in preventing post-operative adhesion formation and to compare it with the efficacy of hyaluronate/carboxymethylcellulose membrane in a rat model. MATERIALS AND METHODS Following pilot studies, 35 rats were operated on in the full study. In 15 animals (group one), 10 standard lesions were inflicted in each uterine horn (total 30 horns) ...
متن کاملClinical Effect of a Mixed Solution of Sodium Hyaluronate and Sodium Carboxymethylcellulose During the Transconjunctival Approach for Orbital Wall Reconstruction
This study aimed to evaluate the anti-adhesive effect of a mixed solution of sodium hyaluronate and sodium carboxymethylcellulose (HACMC, Guardix-sol®) during the transconjunctival approach to orbital wall reconstruction. Eighty-seven patients who underwent orbital wall reconstruction by the transconjunctival approach were enrolled in this prospective study. We applied HACMC between the orbicul...
متن کامل