Evaluating DividPro film for preventing abdominal adhesions after surgery

A Randomized and Single-blinded Pilot Study to Evaluate the Safety and Effectiveness of DividPro Film in Open Abdominal Surgery

This study is testing if a new film called DividPro can help prevent painful scar tissue from forming after open abdominal surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Industrial Technology Research Institute, Taiwan (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06142526 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of DividPro film in reducing abdominal adhesions following open abdominal surgery. Participants will be randomly assigned to receive either the DividPro film implantation or standard care without any anti-adhesion products just before the closure of their surgical incision. Throughout the study, participants will undergo various assessments, including adverse event monitoring, laboratory tests, abdominal ultrasounds, and quality of life questionnaires to evaluate the film's efficacy. Follow-up visits will occur at specified intervals to gather comprehensive data on outcomes related to adhesion and overall patient well-being.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20-70 who are scheduled for open abdominal surgery involving organs such as the liver, gallbladder, pancreas, or intestines.

Not a fit: Patients who are hypersensitive to the ingredients in DividPro film or those currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of painful abdominal adhesions, improving recovery and quality of life for patients undergoing open abdominal surgery.

How similar studies have performed: While the use of adhesion barriers is common, the specific application of DividPro film in this context is relatively novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent before any study specific procedure is performed.
2. Ages of 20-70 years old on the day of consent.
3. Subject who is diagnosed with a liver, gallbladder, pancreas and upper/lower gastrointestinal disorder.
4. Subject who is scheduled to accept an open abdominal operation involving liver, gallbladder, pancreas, stomach, spleen, intestine or female pelvic organ.
5. The Investigational product can be implanted appropriately between the surgical wound and operated organ and is able to cover the entire wound area.

Exclusion Criteria:

1. Subject who is hypersensitive to the ingredient of DividPro film \[Poly (DL-lactide)\]
2. Subject who is concurrently participating in another clinical trial with a drug or a device.
3. Subject who has taken Immunosuppressive drugs/agents long-term or taken NSAIDs within 7 days before trial's operation.
4. Subject who has participated in a clinical trial with a drug or a device within 30 days prior to this study.
5. Subject who has received or is expected to receive any other product or technique belonging to the group of adhesion reduction devices or other products, meshes, or other types of implants in the abdominal cavity within 30 days prior to or during enrollment.
6. Subject who has had hernia mesh placed under the abdominal wall.
7. Subject with peritonitis.
8. Subject with hematological, neurological or immune critical illness.
9. Subject who has malnutrition, uncontrolled diabetes or any other conditions that the investigator considers might not be suitable for enrollment to the study.
10. Subject with other potential infections.
11. Subject with BMI≧40.
12. Female subject who is lactating or pregnant.

Where this trial is running

Taipei

• National Taiwan University Cancer Center — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Yao-Ming Wu, MD — National Taiwan University Hospital
• Study coordinator: Wei Lin Yu, Master

Conditions Open Abdominal Surgery; Abdominal Adhesion; adhesion barrier; abdominal surgery