Intraperitoneal AdhesionsPhase 2NCT00512356
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
A Phase 2 study testing Anti-Adhesion Product in people with Intraperitoneal Adhesions, run by Baxter Healthcare Corporation at 7 sites in 3 countries.
Trial summary
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraperitoneal Adhesions
- What is being tested?
- Anti-Adhesion Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Dec 2000to Apr 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
- Male or female subjects > 18 years of age
- Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
- Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.
Who cannot join
- Pre operative:
- Pregnancy and lactation period
- Subjects concurrently participating in another clinical trial with a drug or a device
- Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
- Subjects who have had abdominal/pelvic surgery within six months prior to this study
- Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation
Show all 12Show fewer
- Intra operative:
- Subjects with peritonitis
- Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
- Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
- Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
- Subjects with major fecal contamination needing an abdominal lavage during the first surgery
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Sweden3 sites
Göteborg University, Department of Surgery, Colorectal Unit
Gothenburg, 416 85
Söder Sjukhuset, Department of Surgery
Stockholm, 118 83
Uddevalla Sjukhus, Kirurg Kliniken
Uddevalla, 451 80
Denmark2 sites
Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
Copenhagen, 2120
Odense University Hospital, Surgical Gastroenterology Department
Odense, 5000
Poland2 sites
Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
Warsaw, 00 909
Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
Warsaw, 02 781
About this study
Official title: Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.
- Conditions
- Intraperitoneal Adhesions
- Being tested
- Anti-Adhesion Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Adhesion ProductBiological
Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.
| Study group | Role | What they receive |
|---|---|---|
| Investigational product group | Experimental | Anti-Adhesion Product was applied to the rectal stump and the incision line.
Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. Receives: Biological: Anti-Adhesion Product |
| Control group | No intervention | Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adhesions around the rectal stump and/or incision line
Secondary outcomes (6)
Number of subjects with no adhesions
Extent and severity of adhesions around the rectal stump
Extent and severity of adhesions at the incision line
Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
Time to reach and free the rectal stump
Safety (laboratory evaluation, recording of adverse experiences)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startDec 2000
- Primary completion25 Feb 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraperitoneal AdhesionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, MD, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512356
- Sponsor's protocol ID
- 549902
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2007
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
- ClinicalTrials.gov ID
- NCT00512356
- Acronym / sponsor ID
- 549902
- Conditions
- Intraperitoneal Adhesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- 25 Feb 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 7 Aug 2007 (estimated)
- 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.
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational product group | Experimental | Biological: Anti-Adhesion ProductAnti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. |
| Control group | No intervention | –Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
- Male or female subjects > 18 years of age
- Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
- Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.
Key exclusion criteria (12 listed)
- Pregnancy and lactation period
- Subjects concurrently participating in another clinical trial with a drug or a device
- Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
- Subjects who have had abdominal/pelvic surgery within six months prior to this study
- Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation
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 |
|---|---|---|
| Anti-Adhesion ProductAnti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components. | Biological | Investigational product group |
Primary outcome
Incidence of adhesions around the rectal stump and/or incision line
6 secondary outcomes
Number of subjects with no adhesions
Extent and severity of adhesions around the rectal stump
Extent and severity of adhesions at the incision line
Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
Time to reach and free the rectal stump
Safety (laboratory evaluation, recording of adverse experiences)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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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.
Baxter BioScience Investigator, MD principal investigator
Baxter Healthcare Corporation
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Adhesion Product in people with Intraperitoneal Adhesions, run by Baxter Healthcare Corporation at 7 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Denmark, Poland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adhesions around the rectal stump and/or incision line. 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 4 Aug 2017.