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

NCT06142526 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

  • Open Abdominal Surgery
  • Abdominal Adhesion

Interventions

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.

Sponsors & Collaborators

  • Industrial Technology Research Institute, Taiwan

    lead OTHER

Principal Investigators

  • Yao-Ming Wu, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06142526 on ClinicalTrials.gov