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 range20 Years – 70 Years
SexALL
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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
✕. 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.
✕
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 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.