Sepra* Adhesion Barrier Technology
Proven clinical results
Below are summaries of several studies published involving the Genzyme
Seprafilm* product. The Bard* Sepramesh* IP Composite hernia repair product
and the Genzyme Seprafilm* products are both based on the Sepra* Adhesion
Barrier Technology, which has 11 years of clinically demonstrated success
and is built upon two key components: sodium hyaluronate (HA) and
carboxymethylcellulose (CMC).
The Bard* Sepramesh* IP Composite is indicated for use in hernia repair, and
the Sepra* Adhesion Barrier Technology minimizes adhesions to the mesh.
The Genzyme Seprafilm* product is indicated for use in abdominal and pelvic
laparotomy as an adjunct intended to reduce the incidence, extent and
severity of postoperative adhesions between the abdominal wall and the
underlying viscera.
Prevention of Postoperative Abdominal Adhesions by a Sodium
Hyaluronate-Based Bioresorbable Membrane:
A Prospective, Randomized, Double-Blind Multicenter Study
Journal of the American College of Surgeons (1996) Vol. 183, No. 4: 297-306
James M. Becker, MD, FACS, et al 1
• Objective: Assess the incidence
closure eight to 12 weeks later, laparoscopy was used to evaluate
of adhesions that recurred
the incidence, extent, and severity of adhesion formation to the
after a standardized major
midline incision.
abdominal operation using
direct laparoscopic peritoneal
• Results: Data were analyzed for 175 assessable patients. While
imaging and to determine
only five (6 percent) of 90 control patients had no adhesions,
the safety and effectiveness of a sodium hyaluronate and
43 (51 percent) of 85 patients receiving HA membrane were
carboxymethylcellulose bioresorbable membrane (HA) in preventing
free of adhesions (p<0.00000000001). Dense adhesions were
postoperative adhesions.
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).
• Study Design: Eleven centers enrolled 183 patients with ulcerative
colitis or familial polyposis who were scheduled for colectomy and
• Conclusions: In this study, HA membrane was safe and significantly
ileal pouch-anal anastomosis with diverting-loop ileostomy. Before
reduced the incidence, extent, and severity of postoperative
abdominal closure, patients were randomly assigned to receive or not
abdominal adhesions.
receive HA membrane placed under the midline incision. At ileostomy
1
This study was supported in full by a grant from Genzyme Corporation, which manufactures Seprafilm*.
Reduction in Adhesive Small-Bowel Obstruction by
Seprafilm* Adhesion Barrier After Intestinal Resection
Diseases of the Colon & Rectum (2005) 49: 1-11
Victor W. Fazio, MB, MS, et al 2
• Objective: To determine whether
• Results: There was no difference between the treatment and control
the use of Seprafilm would
group in overall rate of bowel obstruction. The incidence of adhesive
reduce adhesive small bowel
small-bowel obstruction requiring reoperation was significantly
obstruction (ASBO).
lower for Seprafilm* patients compared with no-treatment
*
patients: 1.8 vs. 3.4 percent (p<0.05). This finding represents an
• Study Design: This was a
absolute reduction in adhesive small-bowel obstruction requiring
prospective, randomized, multicenter, multinational, single-blind,
reoperation of 1.6 percent and a relative reduction of 47
controlled study. This report focuses on those patients who
percent. In addition, a stepwise multivariate analysis indicated
underwent intestinal resection (n=1,701). Before closure of
that the use of Seprafilm* was the only predictive factor for
the abdomen, patients were randomized to receive Seprafilm
reducing adhesive small-bowel obstruction requiring reoperation.
®
or no treatment. Seprafilm* was applied to adhesiogenic
tissues throughout the abdomen. The incidence and type of
• Conclusions: The overall bowel obstruction rate was unchanged;
bowel obstruction was compared between the two groups.
however, adhesive small-bowel obstruction requiring reoperation
was significantly reduced by the use of Seprafilm*, which was the
2
only factor that predicted this outcome.
This study was supported by a grant from Genzyme Corporation, which manufactures Seprafilm*.
Fewer Intraperitoneal Adhesions with Use of Hyaluronic
Acid-Carboxymethylcellulose Membrane: A Randomized Clinical Trial
Annals of Surgery (2002) Vol. 235, No. 2: 193-199
Wietske W. Vrijland, MD, et al
• Objective:
the
• Results: A total of 71 patients were randomized; of these,
effectiveness of bioresorbable
To
assess
42 could be evaluated. The incidence of adhesions did not
Seprafilm membrane in preventing
differ significantly between the two groups, but the severity
abdominal
a
of adhesions was significantly reduced in the Seprafilm*
prospective clinical randomized
group both for the midline incision and for the pelvic area.
*
adhesions
in
multicenter trial.
• Conclusions: Seprafilm* antiadhesions membrane appears effective
• Methods: Between April 1996 and September 1998, all patients
in reducing the severity of postoperative adhesions after major
requiring a Hartmann procedure for sigmoid diverticulitis or
abdominal surgery, although the incidence of adhesions was
obstructed rectosigmoid were randomized to either intraperitoneal
not diminished. The authors recommend using Seprafilm* when
placement of the antiadhesions membrane under the midline
relaparotomy or second-look intervention is planned.
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.
* , Davol and Bard are trademarks and/or registered trademarks of C.R. Bard, Inc. or an affiliate.
Sepramesh, Seprafilm and Sepra are registered trademarks of Genzyme Corporation licensed to C.R. Bard, Inc. or an afflitiate.
Please consult product labels and inserts for indications, contraindications, warnings, precautions, and
instructions for use.
©Copyright 2008, C.R. Bard, Inc. All Rights Reserved.
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1.800.556.6275 • www.davol.com