Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.
Primary Outcome Measures:
- To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. [ Time Frame: at repeat cesarean ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine to what extent Seprafilm® decreases the incidence of adhesion formation. [ Time Frame: at repeat cesarean ] [ Designated as safety issue: No ]
- To determine the incidence of adhesion formation during repeat cesarean delivery. [ Time Frame: at repeat cesarean ] [ Designated as safety issue: No ]
- To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores [ Time Frame: at repeat cesarean ] [ Designated as safety issue: Yes ]
- To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months. [ Time Frame: ongoing during trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
1008 |
| Study Start Date: |
July 2008 |
| Estimated Primary Completion Date: |
June 2011 (Final data collection date for primary outcome measure) |
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A: Experimental
Seprafilm®
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Device: Seprafilm®
Seprafilm® placed at time of primary cesarean
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B: Sham Comparator
Control
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Other: Control
no Seprafilm® used at primary cesarean
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This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.
Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.
Purpose
