Studies

Below are summaries of a few clinical studies on SEPRAFILM® use in open abdominal and pelvic surgery.

SEPRAFILM and Adhesion Prevention

In a study of patients receiving SEPRAFILM during two-stage colorectal surgery, SEPRAFILM reduced the incidence of dense adhesions by 75% compared to untreated patients. SEPRAFILM patients were about half as likely to develop adhesions to the application site as patients who did not receive an adhesion barrier.¹

SEPRAFILM and C-Section

In a study of women receiving SEPRAFILM at their first C-section, SEPRAFILM significantly reduced adhesions, resulting in decreased procedure and delivery times at repeat C-section.²

SEPRAFILM and Gynecologic Surgery

In a study of patients undergoing radical pelvic surgery (removal of the ovaries, fallopian tubes, and uterus), patients who received SEPRAFILM had 69% fewer pelvic floor adhesions than patients who did not receive an adhesion barrier.³

In a study of patients receiving SEPRAFILM at open myomectomy, SEPRAFILM reduced the incidence, severity, and extent of uterine adhesions.⁴

SEPRAFILM and the Prevention of Adhesive Small Bowel Obstruction

In a study of patients receiving SEPRAFILM during open abdominal surgery, SEPRAFILM was shown to reduce the number of reoperations required for adhesive small bowel obstruction by 47% relative to patients who did not receive an adhesion barrier.⁵

SEPRAFILM and Reduced Reoperative Complexity

In a series of clinical studies where SEPRAFILM was placed at the initial procedure, SEPRAFILM was shown to reduce adhesions seen at re-operation, resulting in fewer unintended surgical injuries⁶, less operative time^2,7, and reduced blood loss.⁷

Fallopian Tube Either of the pair of tubes that carry the eggs from the ovary to the uterus—also called the uterine tubes Full glossary

Pelvic Floor The network of muscles that supports the bladder, bowel, and in women, the vagina. Full glossary

Ovaries Female reproductive organs that produce eggs and female sex hormones. Full glossary

Adhesions Internal scars that may form after surgery on or between internal organs and/or body tissue. Adhesions between tissues can twist and pull organs out of their normal places. Full glossary

Uterus A female reproductive organ for containing and providing nourishment to a fetus during development prior to birth (often referred to as the womb). Full glossary

Myomectomy The surgical removal of a myoma. A myoma is a tumor consisting of muscle tissue. Full glossary

Cesarean Section A surgical procedure in which your OB/GYN makes an incision through your lower abdomen and then through your uterus in order to access and deliver your baby. An alternative to vaginal birth when indicated by an OB/GYN. Full glossary

1. 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;297-306.

 

2. Fushiki H, Ikoma T, Kobayashi H, Yoshimoto H. Efficacy of SEPRAFILM as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005;91(5):557-561.

 

2. Fushiki H, Ikoma T, Kobayashi H, Yoshimoto H. Efficacy of SEPRAFILM as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005;91(5):557-561.

 

3. Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005;99:301-308.

 

4. Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fert Steril 1996; 66(6);904-910.

 

5. 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;49:1-11.

 

6. 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. Dis Colon Rectum. 2003;46:1200-1207.

 

7. 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;35:940-945.

 

7. 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;35:940-945.