Use of Interceed(TC7) absorbable adhesion barrier to reduce postoperative adhesion reformation in infertility and endometriosis surgery. The Obstetrics and Gynecology Adhesion Prevention Committee. Reduction of adhesion reformation after laparoscopic endometriosis surgery: a randomized trial with an oxidized regenerated cellulose absorbable barrier. Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trial. Prevention of de-novo adhesion formation after laparoscopic myomectomy: a randomized trial to evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier. Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. Initial feasibility study of a sprayable hydrogel adhesion barrier system in patients undergoing laparoscopic ovarian surgery. Reduction of postoperative adhesion formation after laparoscopic ovarian cystectomy.
Interceed(TC7) is a fabric composed of oxidized, regenerated cellulose that was designed to reduce the formation of postsurgical adhesions. We evaluated Interceed(TC7) in a randomized, multicenter clinical study. Sixty-three infertility patients had bilateral pelvic sidewall adhesions removed at laparotomy. One pelvic sidewall was covered by Interceed(TC7) and the other was left uncovered. The deperitonealized areas (N = 205) of all sidewalls were divided into three groups: less than 100 mm2, N = 72; 100-1000 mm2, N = 95; and more than 1000 mm2, N = 38. The effectiveness of Interceed(TC7) was evaluated at laparoscopy 10-98 days after laparotomy. Significantly more adhesions were observed at laparoscopy on the control pelvic sidewalls (48 of 63, 76%) than on the treated sides (26 of 63, 41%) (P less than .0001). The Interceed(TC7)-treated sidewalls also had significantly less area involved with adhesions at laparoscopy (P less than .05, P less than .001, and P less than .001 in the three groups, respectively). Twenty-eight women with severe endometriosis also had significantly more adhesions on the control side (23 of 28, 82%) than on the treated side (14 of 28, 50%) (P less than .05). We conclude that Interceed(TC7) effectively reduced the incidence and extent of postoperative adhesions, even in patients with severe endometriosis. To evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier (Interceed [TC7] Absorbable Adhesion Barrier) in the reduction of adhesion reformation after laparoscopic surgery for endometriosis.
                Thirty-two premenopausal nonpregnant women who had severe endometriosis and complete posterior cul-de-sac obliteration and were undergoing laparoscopic surgery were randomly assigned to either surgery alone or surgery and Interceed. None of the subjects received any other treatment for adhesion prevention. Second-look laparoscopy was performed 12-14 weeks after laparoscopic surgery by an investigator blinded to the treatment, and the incidence of adhesion-free subjects was assessed.
                Twelve of 16 (75%) women treated with the oxidized regenerated cellulose barrier were free of adhesions, compared with two of 16 (12.5%) controls, a statistically significant difference (P < .05).
                The oxidized regenerated cellulose absorbable barrier significantly reduces adhesion reformation after laparoscopic surgery for endometriosis. To assess the effectiveness of bioresorbable Seprafilm membrane in preventing abdominal adhesions in a prospective clinical randomized multicenter trial.
                Adhesions occur frequently after abdominal operations and are a common cause of bowel obstruction, chronic abdominal pain, and infertility. To reduce the formation of adhesions, a mechanical barrier composed of hyaluronic acid and carboxymethylcellulose was developed, preventing adherence of tissues after abdominal surgery.
                Between April 1996 and September 1998, all patients requiring a Hartmann procedure for sigmoid diverticulitis or obstructed rectosigmoid were randomized to either intraperitoneal placement of the antiadhesions membrane under the midline during laparotomy and in the pelvis, or as a control. Direct visual evaluation of the incidence and severity of adhesions was performed laparoscopically at second-stage surgery for restoration of the continuity of the colon.
                A total of 71 patients were randomized; of these, 42 could be evaluated. The incidence of adhesions did not differ significantly between the two groups, but the severity of adhesions was significantly reduced in the Seprafilm group both for the midline incision and for the pelvic area. Complications occurred in similar numbers in both groups.
                Seprafilm antiadhesions membrane appears effective in reducing the severity of postoperative adhesions after major abdominal surgery, although the incidence of adhesions was not diminished. The authors recommend using Seprafilm when relaparotomy or second-look intervention is planned. Long-term studies are needed to assess the cost-effectiveness and value of Seprafilm in preventing bowel obstruction, chronic abdominal pain, and infertility. To evaluate the effectiveness of the oxidized regenerated cellulose absorbable barrier (Interceed, TC7) in the prevention of de-novo adhesion formation after laparoscopic myomectomy, a prospective and randomized study was performed at the Department of Obstetrics and Gynaecology of the University of Cagliari, Cagliari, Italy. A total of 50 pre-menopausal non-pregnant women, aged 23-42 years, who submitted to laparoscopic myomectomy from January 1993 to June 1994, were randomized to surgery alone (control group, n = 25) or surgery and oxidized regenerated cellulose barrier (Interceed group, n = 25). Neither group received any other treatment for adhesion prevention. A second-look laparoscopy was performed 12-14 weeks after laparoscopic myomectomy. The incidence of adhesion-free patients was assessed at second-look laparoscopy by an investigator not informed of the treatment. The numbers of adhesion-free patients were three out of 25 (12%) in the control group and 15 out of 25 (60%) in the treatment group (P < 0.05). In conclusion, the oxidized regenerated cellulose absorbable barrier significantly reduced de-novo adhesion formation after laparoscopic myomectomy. To compare the impact of expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane; W. L. Gore & Associates, Inc., Flagstaff, AZ) and oxidized regenerated cellulose (Interceed TC7, Johnson & Johnson Medical, Inc., Arlington, TX) on the development of postsurgical adhesions.
                A multicenter, nonblinded, randomized clinical trial.
                University medical centers.
                Each barrier was allocated randomly to the left or right sidewall of every patient.
                Thirty-two women with bilateral pelvic sidewall adhesions undergoing reconstructive surgery and second-look laparoscopy.
                Adhesion score (on a 0- to 11-point scale), the area of adhesion (cm2), and the likelihood of no adhesions.
                The use of both barriers was associated with a lower adhesion score and area of adhesion postoperatively. However, those sidewalls covered with PTFE had a significantly lower adhesion score (0.97 +/- 0.30 versus 4.76 +/- 0.61 points, mean +/- SEM) and area of adhesion (0.95 +/- 0.35 versus 3.25 +/- 0.62 cm2). Overall, more sidewalls covered with PTFE had no adhesions (21 versus 7) and, when adhesions were present on the contralateral sidewall, the number of sidewalls covered with PTFE without adhesions was greater than those covered with oxidized regenerated cellulose (16 versus 2).
                Expanded polytetrafluoroethylene was associated with fewer postsurgical adhesions to the pelvic sidewall than oxidized regenerated cellulose. Postoperative abdominal adhesions are associated with numerous complications, including small bowel obstruction, difficult and dangerous reoperations, and infertility. A sodium hyaluronate and carboxymethylcellulose bioresorbable membrane (HA membrane) was developed to reduce formation of postoperative adhesions. The objectives of our prospective study were to assess the incidence of adhesions that recurred after a standardized major abdominal operation using direct laparoscopic peritoneal imaging and to determine the safety and effectiveness of HA membrane in preventing postoperative adhesions.
                Eleven centers enrolled 183 patients with ulcerative colitis or familial polyposis who were scheduled for colectomy and ileal pouch-anal anastomosis with diverting-loop ileostomy. Before abdominal closure, patients were randomly assigned to receive or not receive HA membrane placed under the midline incision. At ileostomy closure eight to 12 weeks later, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision.
                Data were analyzed for 175 assessable patients. While only five (6 percent) of 90 control patients had no adhesions, 43 (51 percent) of 85 patients receiving HA membrane were free of adhesions (p < 0.00000000001). The mean percent of the incision length involved was 63 percent in the control group, significantly greater than the 23 percent observed in patients who received HA membrane (p < 0.001). Dense adhesions were observed in 52 (58 percent) of the 90 control patients, but in only 13 (15 percent) of the 85 receiving HA membrane (P < 0.0001). Comparison of the incidence of specific adverse events between the groups did not identify a difference (P > 0.05).
                This study represents the first controlled, prospective evaluation of postoperative abdominal adhesion formation and prevention after general abdominal surgery using standardized, direct peritoneal visualization. In this study, HA membrane was safe and significantly reduced the incidence, extent, and severity of postoperative abdominal adhesions. To assess the safety and effectiveness of SprayGel as a barrier to reduce the frequency of adhesion formation and reformation after ovarian surgery, and to determine the feasibility of the study design for a larger, multicenter pivotal trial.
                Prospective, randomized, internally controlled trial (Canadian Task Force classification I).
                Two metropolitan, academic-affiliated, nonprofit hospitals.
                Fourteen women.
                Bilateral adnexal surgery.
                On completion of surgery, one adnexa was randomized to receive optimal surgical treatment plus application of the adhesion barrier, and the contralateral one to receive optimal surgical treatment alone. Patients returned in 3 to 16 weeks for second-look laparoscopy. All initial and second-look procedures were videotaped and reviewed by a blinded surgeon reviewer, and assessed for frequency, extent, and severity of adhesions. The frequency and extent of adhesion formation at second-look laparoscopy were statistically reduced on treatment sides compared with control sides (71% reduction in frequency, p = 0.0488; 69% reduction in extent, p = 0.0494). Adhesion severity score was reduced by 43% on the treatment side. SprayGel was associated with no adverse effects and was applied successfully in all patients.
                This material shows great promise in preventing postoperative adhesion formation in a population of patients greatly in need of such an adjunct. These findings warrant a larger, pivotal, multicenter study to evaluate SprayGel further. The purpose of this randomized, open-label study was to assess the efficacy of the product Interceed absorbable adhesion barrier in the prevention of adhesion formation on the ovary after laparoscopic ovarian cystectomy. A total of 25 patients requiring laparoscopic bilateral ovarian cystectomy were enrolled into this study. After removal of ovarian cysts, peri-adnexal adhesions, and peritoneal irrigants, and the attainment of meticulous haemostasis, the random assignment of one ovary for wrapping with Interceed was revealed to the surgeon. The other ovary served as the untreated control. A follow-up laparoscopy was performed 8-30 weeks after the initial procedure in 17 patients. Significantly fewer adhesions formed at the Interceed treated ovaries compared with the control (untreated) ovaries (P < 0.05). In terms of adhesion-free outcome, 76% (13/17) of Interceed treated ovaries and 35% (6/17) of control ovaries were free of adhesions. A significant reduction was observed in the area of the sutured ovaries involved with adhesions when Interceed (6%) was used, compared with controls (20%). The reduction of adhesion formation was not related to the size of the cysts at the initial procedure. No adverse events were reported by any patient during the study. In conclusion, Interceed was found to be safe and effective in reducing the incidence of postoperative adhesion formation in patients undergoing laparoscopic ovarian cystectomy.
The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.