Document Detail


Clinical assessment of a novel antiadhesion barrier gel: prospective, randomized, multicenter, clinical trial of ADCON-L to inhibit postoperative peridural fibrosis and related symptoms after lumbar discectomy.
MedLine Citation:
PMID:  9506196     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A prospective, multicenter, randomized, double-blind, controlled study of ADCON-L Anti-Adhesion Barrier Gel (a medical device by Gliatech Inc, Cleveland, OH) was conducted in 298 patients undergoing first-time lumbar discectomy to evaluate the safety and effectiveness of ADCON-L in preventing postoperative peridural fibrosis and in improving patient clinical outcome. After lumbar discectomy, patients were randomized to receive either ADCON-L gel or nothing (control group) at the conclusion of the surgical procedure. Six months after surgery, peridural scar was evaluated by magnetic resonance imaging, and postoperative pain and straight-leg-raise angle were assessed. No statistically significant differences between the ADCON-L and control groups were observed in terms of adverse events or wound healing characteristics. ADCON-L gel was shown to be safe and to significantly inhibit peridural scar compared with the control group (P = 0.002). That peridural scarring was reduced with ADCON-L gel was further supported by direct visualization of scar tissue at reoperation in both groups. ADCON-L-treated patients had better clinical outcomes than did control patients. The incidence of activity-related pain was significantly reduced (P = 0.013), straight-leg-raise examination scores were significantly improved (P = 0.024 on the operative side and P = 0.015 on the nonoperative side), and ADCON-L reduced low back pain when it was most severe (P = 0.047) and at the end of the day (P = 0.044).
Authors:
N de Tribolet; F Porchet; T W Lutz; O Gratzl; J Brotchi; H A van Alphen; R E van Acker; A Benini; K N Strommer; R L Bernays; J Goffin; E A Beuls; J S Ross
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of orthopedics (Belle Mead, N.J.)     Volume:  27     ISSN:  1078-4519     ISO Abbreviation:  Am J. Orthop.     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-05-05     Completed Date:  1998-05-05     Revised Date:  2010-01-05    
Medline Journal Info:
Nlm Unique ID:  9502918     Medline TA:  Am J Orthop (Belle Mead NJ)     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  111-20     Citation Subset:  IM    
Affiliation:
Department of Neurosurgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
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MeSH Terms
Descriptor/Qualifier:
Adult
Cicatrix / diagnosis,  etiology,  prevention & control*
Double-Blind Method
Dura Mater / drug effects,  pathology*
Epidural Space / drug effects,  pathology
Female
Fibrosis
Gels / administration & dosage*,  adverse effects
Humans
Intervertebral Disk Displacement / diagnosis,  surgery*
Laminectomy / adverse effects*
Lumbar Vertebrae / surgery*
Magnetic Resonance Imaging
Male
Middle Aged
Organic Chemicals
Pain, Postoperative / etiology,  physiopathology
Postoperative Complications / prevention & control
Prospective Studies
Tissue Adhesions / prevention & control
Treatment Outcome
Wound Healing
Chemical
Reg. No./Substance:
0/ADCON-L; 0/Gels; 0/Organic Chemicals

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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