A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery
NCT ID: NCT06142526
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-12
2025-12-31
Brief Summary
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Detailed Description
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In this study, participant who meets the eligibility criteria will be enrolled and randomized to either the treatment or control group. During the surgery period, subject will have the DividPro film implantation or only the standard care procedure right before the closure of the surgical wound. Participants will be instructed to return for visits on day 7, month 1, 3, 6 and 12. Adverse event, clinical laboratory test, vital sign and physical examination will be tested and recorded during the course of the study as the items of safety assessment. In addition, symptom related to tissue adhesion, visceral sliding test and quality of life questionnaire will also be assessed as the parameters of efficacy at the predetermined time points throughout the study .
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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treatment group
DividPro film implantation right before the closure of surgical incision wound
DividPro film
DividPro Film is a sterile biodegradable translucent film that served as a physical barrier for preventing the adhesion between two adjacent layers of tissue in wound healing process.
control group
Only standard care without any anti-adhesion related products.
No interventions assigned to this group
Interventions
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DividPro film
DividPro Film is a sterile biodegradable translucent film that served as a physical barrier for preventing the adhesion between two adjacent layers of tissue in wound healing process.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
70 Years
ALL
No
Sponsors
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Industrial Technology Research Institute, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Yao-Ming Wu, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Cancer Center
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yao-Ming Wu, MD
Role: primary
Other Identifiers
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ITRIDP20220510
Identifier Type: -
Identifier Source: org_study_id