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.
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).
de Tribolet
N
N
Department of Neurosurgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Porchet
F
F
Lutz
T W
TW
Gratzl
O
O
Brotchi
J
J
van Alphen
H A
HA
van Acker
R E
RE
Benini
A
A
Strommer
K N
KN
Bernays
R L
RL
Goffin
J
J
Beuls
E A
EA
Ross
J S
JS
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
C104199:ADCON-L; D005782:Gels; D009930:Organic Chemicals