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Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer

NCT01095367 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-26

No results posted yet for this study

Summary

The purpose of this research is to determine if a film to prevent adhesions will improve the area of distribution of a contrast dye (representative of chemotherapy) in the abdominal cavity (belly) of women who have undergone surgery for ovarian cancer as compared with patients who have not had adhesion barrier sheets placed in the belly. It is believed that this film, Seprafilm™, reduces adhesions (scar tissue between tissues and organs) in the abdominal cavity following surgery. Adhesions can limit the distribution of the chemotherapy agent placed in the abdomen to treat the ovarian cancer. Thirty subjects will receive adhesion barrier sheets and thirty will not. To determine if the sheets prevent adhesions, all subjects will have a dye inserted into the abdomen and then have X-rays of the abdomen to look at the distribution of the dye between the two groups.

Hypothesis:

Null hypothesis: There is no difference in area of distribution of the intraperitoneal dye in the Seprafilm ™ vs. no Seprafilm™ groups.

Alternative hypothesis: Seprafilm™ reduces adhesion formation and there is a larger area of distribution of intraperitoneal dye in the Seprafilm™ group.

Conditions

  • Epithelial Ovarian Cancer

Interventions

PROCEDURE

Seprafilm™

Seprafilm™ Adhesion Barrier is an approved temporary, bioresorbable adhesion barrier to reduce the incidence, extent, and severity of adhesions in patients undergoing abdominal or pelvic laparotomy. Seprafilm sheets are size 5" x 6" individually-wrapped, sterile membranes. Three or more Seprafilm™ sheets will be placed in the randomized cohort.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Dr. Dianne Miller · British Columbia Cancer Agency

  • Mark S Carey, MD · University of British Columbia

  • Thomas G Ehlen, MD · University of British Columbia

  • Sarah Finlayson, MD · University of British Columbia

  • Janice Kwon, MD · University of British Columbia

  • Gavin CE Stuart, MD · University of British Columbia

  • Anna Tinker, MD · British Columbia Cancer Agency

  • Mark Heywood, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-10-31
Completion
2014-01-31

Countries

  • United States
  • Canada

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 NCT01095367 on ClinicalTrials.gov