Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-25 @ 5:41 AM
Study NCT ID:
NCT00512356
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2007-08-06', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adhesions around the rectal stump and/or incision line'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with no adhesions'}, {'measure': 'Extent and severity of adhesions around the rectal stump'}, {'measure': 'Extent and severity of adhesions at the incision line'}, {'measure': 'Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line'}, {'measure': 'Time to reach and free the rectal stump'}, {'measure': 'Safety (laboratory evaluation, recording of adverse experiences)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intraperitoneal Adhesions']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry\n* Male or female subjects \\> 18 years of age\n* 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\n* Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.\n\nExclusion Criteria:\n\nPre operative:\n\n* Pregnancy and lactation period\n* Subjects concurrently participating in another clinical trial with a drug or a device\n* Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study\n* Subjects who have had abdominal/pelvic surgery within six months prior to this study\n* Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation\n\nIntra operative:\n\n* Subjects with peritonitis\n* Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues\n* Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery\n* 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\n* Subjects with major fecal contamination needing an abdominal lavage during the first surgery"}, 'identificationModule': {'nctId': 'NCT00512356', 'briefTitle': 'Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions', 'orgStudyIdInfo': {'id': '549902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational product group', 'description': 'Anti-Adhesion Product was applied to the rectal stump and the incision line.\n\nLike in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.', 'interventionNames': ['Biological: Anti-Adhesion Product']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '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.'}], 'interventions': [{'name': 'Anti-Adhesion Product', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Investigational product group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2120', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital, Surgical Gastroenterology Department', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '00 909', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02 781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Göteborg University, Department of Surgery, Colorectal Unit', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '118 83', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Söder Sjukhuset, Department of Surgery', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '451 80', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Uddevalla Sjukhus, Kirurg Kliniken', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}], 'overallOfficials': [{'name': 'Baxter BioScience Investigator, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}}}}