NCT06142526

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Industrial Technology Research Institute, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adhesion may occur due to the excessive production of fibrous tissue during the process of wound healing. Abdominal adhesion could play a role on intestine obstruction which will lead to lack of blood flow to the blocked part of the intestine or peritonitis. Improving surgical skills, cleaning wound before closure or using physical barrier between the incision site and abdominal wall can lower the incidence of abdominal adhesion. 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

• Open Abdominal Surgery
• Abdominal Adhesion

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-11-21
• Last updated: 2023-12-18

Locations

1 site across 1 country: Taiwan