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Seprafilm® Adhesion Barrier and Cesarean Delivery

NCT00565643 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 753

Last updated 2024-05-14

Study results available
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Summary

A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).

Conditions

  • Adhesions
  • Cesarean Section
  • Delivery, Obstetric

Interventions

DEVICE

modified sodium hyaluronic acid and carboxymethylcellulose

Adhesion barrier applied at the time of initial cesarean delivery

DEVICE

Placebo

Routine abdominal closure without placement of adhesion barrier

Sponsors & Collaborators

  • Stony Brook University

    collaborator OTHER

  • Lehigh Valley Hospital

    collaborator OTHER

  • Winthrop University Hospital

    lead OTHER

Principal Investigators

  • Daniel G Kiefer, M.D. · Lehigh Valley Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00565643 on ClinicalTrials.gov