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

NCT06142526 | Unknown

• 1 other identifier: ITRIDP20220510
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adhesion barrier; abdominal surgery

Outcome Measures

Primary Outcomes (2)

• Adverse events and serious adverse events and the incidence of both respectively

  from baseline to day 7, and 1, 3, 6 and 12 month

• Incidence of adhesion by using visceral sliding test

  from baseline to 3 month

Secondary Outcomes (5)

• Safety profiles assessment by evaluating the changes in physical examination

  from baseline to day 7, and 1, 3, 6 and 12 month

• Safety profiles assessment by evaluating the changes in laboratory data

  from baseline to day 7, and 1, 3, 6 and 12 month

• Safety profiles assessment by evaluating the changes in vital signs

  from baseline to day 7, and 1, 3, 6 and 12 month

• Incidence of adhesion by using visceral sliding test

  from baseline to day 7, and 1, 6 and 12 month

• Changes in the score of Small Bowel Obstruction Questionnaire

  from baseline to day 7, and 1, 3, 6 and 12 month

Study Arms (2)

treatment group

EXPERIMENTAL

DividPro film implantation right before the closure of surgical incision wound

Device: DividPro film

control group

NO INTERVENTION

Only standard care without any anti-adhesion related products.

Interventions

DividPro film DEVICE

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.

treatment group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject who has malnutrition, uncontrolled diabetes or any other conditions that the investigator considers might not be suitable for enrollment to the study.
• Subject with other potential infections.
• Subject with BMI≧40.
• Female subject who is lactating or pregnant.

Sponsors & Collaborators

• Industrial Technology Research Institute, Taiwan: lead

Study Sites (1)

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

Study Officials

• Yao-Ming Wu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Lin Yu, Master

CONTACT

03-5912926; yuweilin@itri.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 21, 2023
• Study Start: December 12, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-11

Locations

TW (1)