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

Am J Orthop (Belle Mead NJ). 1998 Feb;27(2):111-20.

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).

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cicatrix / diagnosis
  • Cicatrix / etiology
  • Cicatrix / prevention & control*
  • Double-Blind Method
  • Dura Mater / drug effects
  • Dura Mater / pathology*
  • Epidural Space / drug effects
  • Epidural Space / pathology
  • Female
  • Fibrosis
  • Gels / administration & dosage*
  • Gels / adverse effects
  • Humans
  • Intervertebral Disc Displacement / diagnosis
  • Intervertebral Disc Displacement / surgery*
  • Laminectomy / adverse effects*
  • Lumbar Vertebrae / surgery*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Organic Chemicals
  • Pain, Postoperative / etiology
  • Pain, Postoperative / physiopathology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Tissue Adhesions / prevention & control
  • Treatment Outcome
  • Wound Healing

Substances

  • ADCON-L
  • Gels
  • Organic Chemicals