Patrick Fransen1. 1. Brussels Neurosurgery Center, Clinique du Parc Léopold, 1040 Brussels, Belgium. fransenp@yahoo.fr
Abstract
BACKGROUND CONTEXT: An excessive amount of scar tissue after lumbar microdiscectomy may increase postoperative pain. Several fibrosis inhibitors have been used in the past in an endeavor for better functional outcome. PURPOSE: The goal of this study was to evaluate DuraSeal Xact Adhesion Barrier and Sealant System (DSX), a polyethylene glycol-based synthetic fibrosis inhibitor, for its ability to reduce postoperative painafter lumbar microdiscectomy. STUDY DESIGN: This is a prospective randomized controlled study. PATIENT SAMPLE: Twenty patients between 19 and 71 years of age about to undergo elective lumbar single-level discectomy were randomized into two groups of 10. OUTCOME MEASURES: Assessments included the visual analog scale (VAS) pain score, the short form (SF)-36 questionnaire, and the Oswestry low back pain scale, preoperatively and at discharge, and 30, 90, and 180 days after surgery. METHODS: One group was treated with DSX, and the control group received the local standard of care. DSX was applied as a thin layer on the nerve root and surrounding area after microdiscectomy. RESULTS: The VAS pain scale was lower at all time points in the DSX treatment group than in the control group. The reductions at 30, 90, and 180 days for DSX and control groups, respectively, were 43.9% versus 35.6%, 64.3% versus 44.8%, and 75.4% versus 59.6%. The SF-36 scores in the DSX treatment group showed more improvement than in the control group as soon as 30 days for physical functioning, general health, vitality, social functioning, mental health, and emotional patterns, and by 90 days for bodily pain and general health. The Oswestry pain score was lower at all time points in the DSX treatment group than in the control group. The reductions at 30, 90, and 180 days for DSX and control groups, respectively, were 41.5% versus 34.3%, 68.2% versus 42.4%, and 73.3% versus 55.4%. Wound healing was normal in the DSX treatment group, there were no complications related to DSX use, and no patient in either group required reoperation. CONCLUSIONS: Although this study is too small to have conclusions of efficacy and will need confirmation by larger trials, treatment of a microdiscectomy site with DSX for fibrosis prevention shows promising results in terms of safety, reduction of postoperative pain and functional results when compared to control with the additional advantage of being suitable for use in the presence of a dural tear. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
BACKGROUND CONTEXT: An excessive amount of scar tissue after lumbar microdiscectomy may increase postoperative pain. Several fibrosis inhibitors have been used in the past in an endeavor for better functional outcome. PURPOSE: The goal of this study was to evaluate DuraSeal Xact Adhesion Barrier and Sealant System (DSX), a polyethylene glycol-based synthetic fibrosis inhibitor, for its ability to reduce postoperative pain after lumbar microdiscectomy. STUDY DESIGN: This is a prospective randomized controlled study. PATIENT SAMPLE: Twenty patients between 19 and 71 years of age about to undergo elective lumbar single-level discectomy were randomized into two groups of 10. OUTCOME MEASURES: Assessments included the visual analog scale (VAS) pain score, the short form (SF)-36 questionnaire, and the Oswestry low back pain scale, preoperatively and at discharge, and 30, 90, and 180 days after surgery. METHODS: One group was treated with DSX, and the control group received the local standard of care. DSX was applied as a thin layer on the nerve root and surrounding area after microdiscectomy. RESULTS: The VAS pain scale was lower at all time points in the DSX treatment group than in the control group. The reductions at 30, 90, and 180 days for DSX and control groups, respectively, were 43.9% versus 35.6%, 64.3% versus 44.8%, and 75.4% versus 59.6%. The SF-36 scores in the DSX treatment group showed more improvement than in the control group as soon as 30 days for physical functioning, general health, vitality, social functioning, mental health, and emotional patterns, and by 90 days for bodily pain and general health. The Oswestry pain score was lower at all time points in the DSX treatment group than in the control group. The reductions at 30, 90, and 180 days for DSX and control groups, respectively, were 41.5% versus 34.3%, 68.2% versus 42.4%, and 73.3% versus 55.4%. Wound healing was normal in the DSX treatment group, there were no complications related to DSX use, and no patient in either group required reoperation. CONCLUSIONS: Although this study is too small to have conclusions of efficacy and will need confirmation by larger trials, treatment of a microdiscectomy site with DSX for fibrosis prevention shows promising results in terms of safety, reduction of postoperative pain and functional results when compared to control with the additional advantage of being suitable for use in the presence of a dural tear. Copyright 2010 Elsevier Inc. All rights reserved.
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