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Seprafilm® for Prevention of Adhesions at Repeat Cesarean

NCT00697606 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2015-12-30

No results posted yet for this study

Summary

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.

Conditions

  • Adhesion Formation After Primary Cesarean Delivery

Interventions

DEVICE

Seprafilm®

Seprafilm® placed at time of primary cesarean

OTHER

Control

no Seprafilm® used at primary cesarean

Sponsors & Collaborators

  • Abington Memorial Hospital

    lead OTHER

Principal Investigators

  • Amy Mackey, MD · Abington Memorial Hospital

  • Mark Shahin, MD · Abington Memorial Hospital

  • Richard Latta, MD · Abington Memorial Hospital

  • David Peleg, MD · Abington Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697606 on ClinicalTrials.gov