Anti-Adhesive Film for Tissue Adhesions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Hypersensitivity to Seprafilm, Unresectable disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During initial surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special film that might reduce tissue adhesions (scar-like tissue that sticks organs together) during repeat liver surgeries. It targets individuals with conditions like colorectal liver metastasis or liver cancer who may require additional surgeries. The study will compare two groups: one will receive the anti-adhesion film (adhesion barrier) during their initial surgery, while the other will not. Ideal candidates for this trial have already undergone liver surgery and are likely to need another. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this anti-adhesive film is safe for reducing tissue adhesions?

Research has shown that Seprafilm, the barrier studied to prevent tissues from sticking together, is safe. Studies have found that it significantly reduces the risk and severity of tissue adhesion after surgeries in the abdominal and pelvic areas. In a large study involving over 2,000 participants, Seprafilm demonstrated safety, with no increased risk of complications such as infections or blood clots in the lungs. Evidence so far supports that Seprafilm is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the anti-adhesive film Seprafilm because it offers a unique approach to preventing tissue adhesions. Unlike traditional treatments, which often involve manual separation or surgical techniques to address adhesions after they form, Seprafilm is an adhesion barrier applied during surgery to prevent their formation in the first place. This proactive approach minimizes postoperative complications and may reduce the need for additional surgeries. By preventing adhesions rather than treating them after they occur, Seprafilm has the potential to improve recovery times and overall surgical outcomes.

What evidence suggests that this anti-adhesive film is effective for reducing tissue adhesions?

Studies have shown that Seprafilm, one of the treatments in this trial, reduces adhesion formation after abdominal and pelvic surgeries. In open surgeries like laparotomy, Seprafilm significantly decreases the frequency and severity of these adhesions. Adhesions are sticky bands of tissue that can form after surgery, complicating future operations. Using Seprafilm lowers the chance of adhesion development, leading to smoother and safer repeat surgeries. Overall, Seprafilm has proven effective in keeping the surgical area clearer and improving outcomes in future operations. Participants in this trial will receive either Seprafilm or no barrier to assess its effectiveness. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of antiadhesion barrier film during initial hepatectomy

During initial surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of peri-hepatic adhesions at repeat surgery

30 days after repeat surgery

Repeat Surgery

Evaluation of peri-hepatic adhesions and other outcomes during repeat hepatic surgery

0-4 years from initial surgery

What Are the Treatments Tested in This Trial?

Interventions

• Adhesion barrier

Trial Overview 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.

How Is the Trial Designed?

Group I: Seprafilm Experimental Treatment 1 Intervention

Antiadhesion barrier applied

Group II: No seprafilm Active Control 1 Intervention

No barrier applied

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3401301/

Seprafilm® adhesion barrier: (2) a review of the clinical ... The safety and efficacy of Seprafilm in reducing postoperative adhesions has been clearly demonstrated in abdominal and pelvic laparotomy. While reports have ...

2. advancedsurgery.baxter.com advancedsurgery.baxter.com/seprafilm

Seprafilm Adhesion Barrier SEPRAFILM is an adhesion barrier that significantly reduces the incidence, extent and severity of adhesions following abdominopelvic laparotomy surgery.

3. advancedsurgery.baxterhealthcare.co.uk advancedsurgery.baxterhealthcare.co.uk/seprafilm

SEPRAFILM Adhesions develop routinely following surgery, and have been reported at second-look surgery to occur in up to 93% of patients (n=210) following laparotomy2.

4. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02581-2

Seprafilm® and adhesive small bowel obstruction in colorectal ... These adhesions can cause chronic abdominal pain, female infertility, difficult re-operative surgery [4], and remain the leading cause of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666534425000108

Gynecologic postoperative anti-adhesion barriers Postoperative adhesions (POA) affect up to 90 % of women following pelvic or abdominal surgery, contributing to infertility, chronic pain, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14530667/

A prospective, randomized, multicenter, controlled study of ... This study confirmed the safety of Seprafilm adhesion barrier with respect to abdominal abscess, pelvic abscess, and pulmonary embolism.

7. corpmedical.cl corpmedical.cl/productos/seprafilm/

Acerca de Seprafilm For detailed Seprafilm efficacy and safety data, click here. ... The safety and effectiveness of Seprafilm Adhesion Barrier in combination with other adhesion ...