title: 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.affiliation: Department of Neurosurgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: de Tribolet
authors.forename: F
authors.initials: F
authors.lastname: Porchet
authors.forename: T W
authors.initials: TW
authors.lastname: Lutz
authors.forename: O
authors.initials: O
authors.lastname: Gratzl
authors.forename: J
authors.initials: J
authors.lastname: Brotchi
authors.forename: H A
authors.initials: HA
authors.lastname: van Alphen
authors.forename: R E
authors.initials: RE
authors.lastname: van Acker
authors.forename: A
authors.initials: A
authors.lastname: Benini
authors.forename: K N
authors.initials: KN
authors.lastname: Strommer
authors.forename: R L
authors.initials: RL
authors.lastname: Bernays
authors.forename: J
authors.initials: J
authors.lastname: Goffin
authors.forename: E A
authors.initials: EA
authors.lastname: Beuls
authors.forename: J S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D000328:Adult; D002921:Cicatrix / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004388:Dura Mater / Q000187:drug effects / Q000473:pathology*; D004824:Epidural Space / Q000187:drug effects / Q000473:pathology; D005260:Female; D005355:Fibrosis; D005782:Gels / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000175:diagnosis / Q000601:surgery*; D007796:Laminectomy / Q000009:adverse effects*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009930:Organic Chemicals; D010149:Postoperative Pain / Q000209:etiology / Q000503:physiopathology; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D000267:Tissue Adhesions / Q000517:prevention & control; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: C104199:ADCON-L; D005782:Gels; D009930:Organic Chemicals