Anti-Adhesive Film for Tissue Adhesions

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?There has been an increase in the need for repeat hepatic surgery, especially for patients with colorectal liver metastasis and hepatocellular carcinoma. Adhesions at the time of repeat surgery can lead to increased operative times, higher blood loss and even increased perioperative morbidity. Not much data exists regarding use of anti-adhesion barriers at the time of index hepatectomy and their effect on adhesions at repeat hepatectomy. This randomized controlled trial aims to evaluate the effectiveness of the use of a hyaluronan and cellulose based antiadhesive topical film at index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.

Eligibility Criteria

This trial is for adults over 18 who are having part of their liver removed and might need another surgery later, like those with colorectal liver metastasis or hepatocellular carcinoma. It's not for patients whose disease can't be operated on, those who can't agree to the study themselves, or people allergic to Seprafilm or its ingredients.

Inclusion Criteria

I am 18 years old or older.

I am likely to need another liver surgery due to my liver cancer or metastasis.

Exclusion Criteria

My cancer cannot be removed with surgery due to its spread.

I am unable to understand and give consent for treatment.

You are allergic to Seprafilm or any of its ingredients.

Participant Groups

The study tests a hyaluronan-cellulose film applied during initial liver surgery to see if it helps reduce tissue sticking together at follow-up surgeries. Participants will be randomly assigned to receive this anti-adhesive barrier or not.

2Treatment groups

Experimental Treatment

Active Control

Group I: SeprafilmExperimental Treatment1 Intervention

Antiadhesion barrier applied

Group II: No seprafilmActive Control1 Intervention

No barrier applied