Open Abdominal SurgeryNCT06142526
A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery
A study testing DividPro film in people with Open Abdominal Surgery and Abdominal Adhesion, run by Industrial Technology Research Institute, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Open Abdominal Surgery, Abdominal Adhesion
- What is being tested?
- DividPro film
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Yao-Ming Wu, MD
Po-Da Chen, MD
About this study
Official title: A Randomized and Single-blinded Pilot Study to Evaluate the Safety and Effectiveness of DividPro Film in Open Abdominal Surgery
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.
Read the 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
- Being tested
- DividPro film
- Keywords
- adhesion barrier, abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DividPro filmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | DividPro film implantation right before the closure of surgical incision wound Receives: Device: DividPro film |
| control group | No intervention | Only standard care without any anti-adhesion related products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events and the incidence of both respectively
Measured: from baseline to day 7, and 1, 3, 6 and 12 month
Incidence of adhesion by using visceral sliding test
Measured: from baseline to 3 month
Secondary outcomes (5)
Safety profiles assessment by evaluating the changes in physical examination
Measured: from baseline to day 7, and 1, 3, 6 and 12 month
Safety profiles assessment by evaluating the changes in laboratory data
Measured: from baseline to day 7, and 1, 3, 6 and 12 month
Safety profiles assessment by evaluating the changes in vital signs
Measured: from baseline to day 7, and 1, 3, 6 and 12 month
Incidence of adhesion by using visceral sliding test
Measured: from baseline to day 7, and 1, 6 and 12 month
Changes in the score of Small Bowel Obstruction Questionnaire
The questionnaire includes measurements for the impact of small bowel obstruction on the patients' quality of life in respect to diet, pain, gastrointestinal symptoms and daily life.
Measured: from baseline to day 7, and 1, 3, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start12 Dec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Industrial Technology Research Institute, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Ming Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142526
- Sponsor's protocol ID
- ITRIDP20220510
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Single-blinded Pilot Study to Evaluate the Safety and Effectiveness of DividPro Film in Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06142526
- Acronym / sponsor ID
- ITRIDP20220510
- Conditions
- Open Abdominal Surgery, Abdominal Adhesion
- Keywords
- adhesion barrier, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Industrial Technology Research Institute, TaiwanUniversity, hospital or other
- Study start
- 12 Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: DividPro filmDividPro film implantation right before the closure of surgical incision wound |
| control group | No intervention | –Only standard care without any anti-adhesion related products. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DividPro filmDividPro 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. | Device | treatment group |
Primary outcome
Adverse events and serious adverse events and the incidence of both respectively
Time frame: from baseline to day 7, and 1, 3, 6 and 12 month
Incidence of adhesion by using visceral sliding test
Time frame: from baseline to 3 month
5 secondary outcomes
Safety profiles assessment by evaluating the changes in physical examination
Time frame: from baseline to day 7, and 1, 3, 6 and 12 month
Safety profiles assessment by evaluating the changes in laboratory data
Time frame: from baseline to day 7, and 1, 3, 6 and 12 month
Safety profiles assessment by evaluating the changes in vital signs
Time frame: from baseline to day 7, and 1, 3, 6 and 12 month
Incidence of adhesion by using visceral sliding test
Time frame: from baseline to day 7, and 1, 6 and 12 month
Changes in the score of Small Bowel Obstruction Questionnaire
Time frame: from baseline to day 7, and 1, 3, 6 and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao-Ming Wu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DividPro film in people with Open Abdominal Surgery and Abdominal Adhesion, run by Industrial Technology Research Institute, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Lin Yu, Master (03-5912926, yuweilin@itri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events and the incidence of both respectively (time frame: from baseline to day 7, and 1, 3, 6 and 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.