Efficacy
More than one million patients have received SEPRAFILM® since its introduction in 1996. More than 4,000 patients have been evaluated in 20 published SEPRAFILM trials.1 Studies have shown that SEPRAFILM reduces the incidence, severity, and extent of adhesions in both abdominal laparotomy3 and pelvic laparotomy5, and that SEPRAFILM reduces adhesion-related morbidities.4,6,7
Efficacy of SEPRAFILM in Abdominal Laparotomy
A randomized, double-blinded, multicenter clinical study involving 183 patients was conducted to evaluate the safety and effectiveness of SEPRAFILM in ulcerative colitis and familial polyposis patients undergoing creation of an ileal pouch with diverting ileostomy.3 Prior to closure, SEPRAFILM was applied directly on the omentum and bowel to separate tissues from the overlying abdominal wall and midline incision. During the ileostomy reversal several months later, the incidence, extent, and severity of adhesions to the midline incision were evaluated (175 patients were evaluable).
In this study, the majority of SEPRAFILM patients were free of adhesions. SEPRAFILM-treated patients in whom adhesions did form were reported to have significantly less extensive and less severe adhesions as compared to untreated control patients. Comparative analysis of the severity of adhesions demonstrated a 75% reduction in the presence of dense adhesions in SEPRAFILM-treated patients as compared to untreated control.
Figure 1
51% of SEPRAFILM patients in the study were free of adhesions at the site of application, compared to 6% of control patients (Figure 1). Application of SEPRAFILM reduced the extent of adhesions (percentage of the incision length involved) by 48% relative to control.
Efficacy of SEPRAFILM in Pelvic Laparotomy
A randomized, double-blinded, multicenter clinical study involving 127 women was conducted to evaluate the safety and effectiveness of SEPRAFILM in patients undergoing myomectomy.5 SEPRAFILM was applied to the anterior and posterior surfaces of the uterus at the primary procedure. Postoperative adhesion formation was evaluated during a second-look laparoscopy performed an average of 23 days after the initial procedure.
In this study, SEPRAFILM reduced the incidence, severity, and extent of adhesions at the site of barrier application. The incidence of adhesions to the uterus was measured at 13 pelvic sites. SEPRAFILM patients demonstrated a significant reduction in incidence of adhesions to the anterior and posterior uterine surfaces, with a mean of 4.98 sites with adhesions to the uterus in SEPRAFILM patients compared to a mean of 7.88 sites in untreated control patients. Seprafilm patients showed a significant reduction in uterine surface area with adhesions (13.25 cm2 ) when compared to untreated control (18.72 cm2 ). In addition, 48% of SEPRAFILM-treated patients were free of adhesions to at least one adnexum.