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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Adhesion barrier in the clinical trial titled 'Anti-Adhesive Film for Tissue Adhesions'?

Research shows that using anti-adhesive barriers, like films or gels, can help reduce the formation of tissue adhesions (bands of scar tissue) after surgery. Studies in animals have demonstrated that these barriers, including those made from materials like hyaluronic acid and alginate, can effectively prevent adhesions by creating a physical separation between tissues. ^{1 2 3 4 5}

Is the anti-adhesive film safe for humans?

The anti-adhesive film, similar to Seprafilm, has been studied in animals and is generally considered safe for preventing tissue adhesions after surgery. Seprafilm is one of the FDA-approved methods for adhesion prevention, indicating its safety profile has been evaluated. ^{3 6 7 8 9}

How does the anti-adhesive film treatment differ from other treatments for tissue adhesions?

The anti-adhesive film treatment is unique because it uses a film made from modified hyaluronic acid and 5-aminosalicylic acid to prevent tissue adhesions after surgery. This film is designed to be applied directly to the affected area, reducing the formation of adhesions by acting as a physical barrier, which is different from other treatments that may use liquids or different materials. ^{1 3 10 11 12}

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 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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of a novel liquid (Adcon-P) and a sodium hyaluronate and carboxymethylcellulose membrane (Seprafilm) in postsurgical adhesion formation in a murine model. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Tissue response to five commercially available peritoneal adhesion barriers-A systematic histological evaluation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Experimental validation for the use of a film on the basis of modified hyaluronic acid for prevention of postoperative peritoneal adhesions. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the SprayGel adhesion barrier in the rat cecum abrasion and rabbit uterine horn adhesion models. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Prevention of postsurgical adhesions using an ultrapure alginate-based gel. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Human-Derived Amniotic Membrane Is Associated With Decreased Postoperative Intraperitoneal Adhesions in a Rat Model. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Preventing adhesions in obstetric and gynecologic surgical procedures. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Physical barriers in adhesion prevention. [2014]

9. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of the Effectiveness of Peritoneal Adhesion Prevention Devices in a Rat Model. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Modified novel technique for improving the success rate of applying seprafilm by using laparoscopy. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The usefulness of re-attachability of anti-adhesive cross-linked gelatin film and the required physical and biological properties. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

In vivo and in vitro feasibility studies of intraocular use of seprafilm to close retinal breaks in bovine and rabbit eyes. [2014]