A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery (NCT06142526) | Clinical Trial Compass
UnknownNot Applicable
A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery
Taiwan60 participantsStarted 2023-12-12
Plain-language summary
Abdominal adhesions frequently occur after surgery and may be one of the main reasons to cause discomfort, pain and related bowel movement symptoms. The goal of this clinical trial is to evaluate the safety of DividPro film and its potential effectiveness for reducing the incidence of abdominal adhesion. Treatment group will have DividPro film implantation right before the closure of surgical incision wound. Control group will have standard care without any anti-adhesion related products. In addition to adverse event assessment and safety lab tests, participants will accept abdominal ultrasound and quality of life questionnaire at each visit for effectiveness evaluation.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent before any study specific procedure is performed.
. Ages of 20-70 years old on the day of consent.
. Subject who is diagnosed with a liver, gallbladder, pancreas and upper/lower gastrointestinal disorder.
. Subject who is scheduled to accept an open abdominal operation involving liver, gallbladder, pancreas, stomach, spleen, intestine or female pelvic organ.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events and serious adverse events and the incidence of both respectively
Timeframe: from baseline to day 7, and 1, 3, 6 and 12 month
2
Incidence of adhesion by using visceral sliding test
Timeframe: from baseline to 3 month
Trial details
NCT IDNCT06142526
SponsorIndustrial Technology Research Institute, Taiwan
. Subject who is hypersensitive to the ingredient of DividPro film \[Poly (DL-lactide)\]
. Subject who is concurrently participating in another clinical trial with a drug or a device.
. Subject who has taken Immunosuppressive drugs/agents long-term or taken NSAIDs within 7 days before trial's operation.
. Subject who has participated in a clinical trial with a drug or a device within 30 days prior to this study.
. 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.
. Subject who has had hernia mesh placed under the abdominal wall.
. Subject with peritonitis.
. Subject with hematological, neurological or immune critical illness.