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Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (694)	4/3/1999 12:14:00 PM
From: M. P. McNamara, Jr. M.D.	Respond to of 2001

Text of Adcon-L abstract to be presented at AANS annual meeting 24-29 April: A Clinical Study of ADCON(Registered)-L: A Bioresorbable Gel for the Prevention of Postoperative Peridural Fibrosis Stewart Dunsker, MD, William Tobler,MD(Cincinnati,OH),The U.S.ADCON-L Clinical Research Group Abstract: Objectives: ADCON(Registered)-L Adhesion Control in a Barrier Gel, shown to inhibit the development of peridural fibrosis in animals and in a previous clinical study, was evaluated in this clinical study for safety, effectiveness in preventing postoperative adhesions, and improving clinical outcome of patients undergoing lumbar discectomy. Methods: The study was designed as a controlled, randomized, double-blind clinical trial and was conducted at 16 U.S. centers. The studies included patients (N = 370) undergoing first-time, unilateral, single-level, discectomy at the L4/L5 or L5/Sl level. Patients received ADCON(Registered)-L gel or no treatment (Control). Fibrosis was quantified 6 months postoperatively by MRI, and evaluated visually in nine cases of reoperation. Clinical outcome was also assessed. A numerical clinical utility index was developed and calculated for each treatment group based upon decreased peridural scar and improvement in clinical outcome measures. A post-study surveillance was conducted on data from study patients who completed assessments at least 12 months postoperatively. Results: There were a total of 370 patients enrolled into the clinical study. An interim analysis of the data shows that patients receiving ADCON(Registered)-L had significantly less peridural scar as measured by MRI six months postoperatively (N = 141 evaluable patients, p = 0.03). When reoperation was required, the surgeons encountered less fibrosis in the ADCON(Registered)-L patients compared to control patients. ADCON(Registered)-L treatment provided a significant benefit in clinical outcome (p = 0.03). The twelve month data from the post-study surveillance are currently being analyzed and will be discussed. A meta-analysis was performed combining the interim data from this study with final data from a previous clinical study conducted at 9 European centers, and demonstrated further that ADCON(Registered)-L patients had significantly less scar than control patients (p = 0.001, N = 407 evaluable patients). In addition, significantly more ADCON(Registered)-L patients were classified as clinical successes using the clinical utility index in the previous study at 6 months (p = 0.002) and 12 months (p = 0.0 13) postoperatively, and for the interim data from this study (p = 0.002). There were no differences between the ADCON(Registered)-L and control groups in adverse events or wound healing characteristics. Summary: The group of patients who received ADCON(Registered)-L have less scar and a better clinical outcome after laminectomy compared to those patients who did not receive the treatment. ADCON(Registered)-L treatment was safe and effective in reducing postoperative peridural scar and its clinical sequelae. ----------------------------------------------------------------------