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

Stopped early · Not applicable

Conditions studied: Epithelial Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT01095367

Run by

University of British Columbia

People needed

15

Starts

2010-04-01

Expected to finish

2014-01-01

Last updated by the study team

2014-09-26

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Epithelial ovarian cancer
• Stage III or IV (advanced)
• Planned intraperitoneal chemotherapy
• Optimally debulked to less than 1 cm residual tumor in any area within the peritoneal cavity (after consent prior to randomization)

Where it is running

• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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