In one study, Seprafilm was shown to be safe in the presence of peritonitis.1

In a prospective, clinical, randomized, controlled trial of patients requiring a Hartmann procedure for sigmoid diverticulitis or obstructed rectosigmoid, 42 patients could be evaluated: 21 were treated with Seprafilm and 21 patients were in the control group. Of those 42 patients, 76% were shown to have peritonitis. Seprafilm was shown to be safe in these patients with peritonitis.1

Seprafilm is shown to be safe in the presence of a bowel anastomosis; however, it shouldn’t be wrapped around an anastamosis.2 See important safety information 13

In the treatment of inflammatory bowel diseases—including colitis and Crohn’s disease, as well as diverticulitis—there is high potential for reoperation. [General medical knowledge] Adhesions can complicate future surgeries and may lead to substantial morbidities such as small bowel obstructions, chronic pelvic pain, and infertility.3-9

Seprafilm has been proven to reduce adhesions which has been shown to lead to

  • Reduced reoperation required for adhesive small bowel obstruction6 
  • Reduced reoperative complexity10,11 
  • Easier ileostomy reversal10 
  • A 74% reduction in the incidence of dense postoperative adhesions12

Seprafilm is proven safe (up to 10 sheets) in the presence of a bowel anastomosis, and did not increase the complication rate when used as directed.2,10

Seprafilm should not be wrapped around a fresh anastomotic suture line because it may increase the potential for anastamotic leaks. See Important Safety Information below.

Click here for relevant clinical studies

Seprafilm application sites following small bowel resection13 :

  • Traumatized bowel
  • Mesentery
  • Incision site
  • Female reproductive organs

Seprafilm application sites following colectomy13:

  • Traumatized colon and small bowel
  • Paracolic sidewall
  • Mesentery
  • Sidewall
  • Incision site
  • Omentum
  • Female reproductive organs
  • Ostomy site

Indication
Seprafilm® Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or pelvic laparotomy.

Important Safety Information
Seprafilm should not be wrapped around an intestinal anastomosis as such usage may result in increased anastomotic leak related events, such as abscess or peritonitis. The safety and effectiveness of Seprafilm has not been established in combination with other adhesion prevention products and/or in surgical procedures not within the abdominopelvic cavity. The safety and effectiveness of Seprafilm has also not been evaluated in cases of pregnancy, malignancy, or frank infection. The type and frequency of adverse events reported are consistent with events typically seen following abdominopelvic surgery when used as directed.

Please see full prescribing information.

References

  1. Vrijland, W.W., et al., Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trial. Annals of surgery, 2002. 235(2): p. 193-9,
  2. Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; for Adhesion Study Group Steering Committee. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm® Adhesion Barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum. 2003;46(10):1310-1319.
  3. Peterson (1970) Laparoscopy of the infertile patient obstet gynecol. 6. Phillippov (1998) Estimation of the prevalence & causes of infertility bull world health organ.
  4. Mishell DR, Davajan V. Evalutation of the infertile couple. In: Mishell DR, Davajan V, Lobo RA, eds. Infertility, Contraception & Reproductive Endocrinology. 3rd ed. Boston, MA: Blackwell Scientific Publications; 1991:557-570.
  5. Growri (2001) Chronic Pelvic Pain Saudi Med J.pdf
  6. Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm Adhesion Barrier after intestinal resection. Dis Colon Rectum. 2005;49(1):1-11
  7. Morales KJ, Gordon MC, Bates GW Jr. Postcesarean delivery adhesions associated with delayed delivery of infant. Am J Obstet Gynecol. 2007;196(5):461.e1-461.e6.
  8. Tulandi T, Agdi M, Zarei A, Miner L, Sikirica V. Adhesion development and morbidity after repeat cesarean delivery. Am J Obstet Gynecol. 2009;201(1):56.e1-56.e6.
  9. Ellis H, Moran BJ, Thompson JN, et al. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999;353(9163):1476-1480.
  10. Tang C-L, Seow-Choen F, Fook-Chong S, Eu K-W. Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision: a prospective randomized trial. Dis Colon Rectum. 2003;46(9):1200-1207.
  11. Kusunoki M, Ikeuchi H, Yanagi H, et al. Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today. 2005;35(11):940-945.
  12. Becker JM, Dayton MT, Fazio VW, et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996;183(4):297-306.
  13. Seprafilm Adhesion Barrier [package insert]. Cambridge, MA: Genzyme Biosurgery; 2008.

Seprafilm placement video

Watch a demonstration of the taco technique being used during a laparotomy closure.

Watch video

Seprafilm may be applied to many sites during ostomy creation13

Seprafilm has been shown to reduce the severity and extent of adhesions to the peristomal incision.11

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