To order Seprafilm or for more information, call 1-800-261-1570 Instructions for Use (IFU)
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IMPORTANT SAFETY INFORMATION

Seprafilm Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of Seprafilm. Seprafilm Adhesion Barrier is contraindicated for use wrapped directly [...]
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For US Healthcare Professionals Only

Seprafilm Clinical Data & Studies

Seprafilm Clinical Efficacy

Seprafilm significantly reduces the incidence, extent, and severity of postsurgical adhesions.1,2

 SEPRAFILM EFFICACY IN ABDOMINAL SURGERY2

In a randomized, double-blinded, multicenter clinical study involving 183 patients (175 evaluable) with ulcerative colitis and familial polyposis undergoing abdominal surgery, more than half of patients treated with Seprafilm were adhesion-free at 12 weeks compared to six percent of untreated patients.

Reduces incidence of adhesions

Reduces severity of adhesions

The safety and efficacy of Seprafilm adhesion barrier has not been evaluated in clinical studies in the presence of malignancies in the abdominopelvic cavity.

 SEPRAFILM EFFICACY IN PELVIC SURGERY3

In a prospective, randomized, blinded, multicenter clinical study involving 127 patients undergoing gynecologic surgery, Seprafilm reduced the mean number of sites adherent to the uterine surface following myomectomy compared with untreated patients. Seprafilm also significantly reduced the extent and severity of adhesions in patients undergoing uterine myomectomy compared with untreated patients.

Reduces incidence of adhesions

Reduces Incidence 
and Extent of Adhesions

In patients undergoing surgery for ovarian, primary peritoneal or fallopian tube malignancies, Seprafilm use has been reported as having an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required.


Seprafilm Clinical Studies

Following are the prospective, randomized clinical Seprafilm studies submitted to the FDA for product approval, as well as the post-market follow-up study.

 ABDOMINAL SURGERY SEPRAFILM STUDIES

Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. [Pivotal Seprafilm Study]

Becker JM, Dayton MT, Fazio VW, et al. J Am Coll Surg. 1996;183(4):297-306.

View abstract

 

A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine.

Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; for Adhesion Study Group Steering Committee. Dis Colon Rectum. 2003;46(10):1310-1319.

View abstract

 

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

Fazio VW, Cohen Z, Fleshman JW, et al. Dis Colon Rectum. 2006;49(1):1-11.

View abstract

 

 PELVIC SURGERY SEPRAFILM STUDY

Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. [Pivotal Seprafilm Study]

Diamond MP; Seprafilm Adhesion Study Group. Fertil Steril. 1996;66(6):904-910.

View abstract

References

  1. Seprafilm® Adhesion Barrier Instructions for Use (IFU); Genzyme Corporation, Cambridge, MA; 2017.
  2. 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.
  3. Diamond MP. Seprafilm Adhesion Study Group. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil Steril. 1996;66(6):904-910.