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.

Abstract

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
• Journal: American journal of orthopedics (Belle Mead, N.J.) (Am J Orthop (Belle Mead NJ)) Vol. 27 Issue 2 Pg. 111-20 (Feb 1998) ISSN: 1078-4519 [Print] United States
• PMID: 9506196 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• ADCON-L
• Gels
• Organic Chemicals

Topics

• 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 Disc 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