A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery

Launched by INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE, TAIWAN · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a product called DividPro film, which is being tested for its safety and effectiveness in reducing abdominal adhesions that can occur after open abdominal surgery. Abdominal adhesions are bands of scar tissue that can form and cause discomfort, pain, and problems with bowel movements. In this trial, one group of participants will receive the DividPro film during their surgery, while another group will receive standard care without any special products to prevent adhesions.

To be eligible for this trial, participants need to be between 20 and 70 years old and scheduled for an open abdominal surgery that involves organs like the liver, gallbladder, or intestines. Before participating, they will need to give written consent. Throughout the trial, participants will have regular check-ups, including abdominal ultrasounds and questionnaires about their quality of life, to help assess how well the DividPro film works. It's important to note that individuals with certain medical conditions or those taking specific medications may not qualify for this study.

Gender

ALL

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.