Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142526
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-11-13
Brief Title:
A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery
Sponsor:
Industrial Technology Research Institute Taiwan
Organization:
Industrial Technology Research Institute Taiwan
Study Overview
Official Title:
A Randomized and Single-blinded Pilot Study to Evaluate the Safety and Effectiveness of DividPro Film in Open Abdominal Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None