Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-04-13 @ 12:07 AM
Study NCT ID:
NCT01685593
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2012-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Binder Study to Decrease Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'amount morphine used in 24 hours postoperatively', 'timeFrame': '24 hours', 'description': 'mg morphine'}], 'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '24 hours', 'description': 'linear pain scale'}], 'secondaryOutcomes': [{'measure': 'ambulations in 24 hours postoperatively', 'timeFrame': '24 hours', 'description': 'number ambulations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abdominal binder'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gynecologic abdominal laparotomy patients\n\nExclusion Criteria:\n\n* non gynecologic abdominal laparotomy patients'}, 'identificationModule': {'nctId': 'NCT01685593', 'briefTitle': 'Abdominal Binder Study to Decrease Postoperative Pain', 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.', 'orgStudyIdInfo': {'id': 'C.2001.128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'regular bandage', 'description': 'no abdominal binder', 'interventionNames': ['Other: no binder']}, {'type': 'EXPERIMENTAL', 'label': 'abdominal binder', 'description': 'binder', 'interventionNames': ['Device: abdominal binder']}], 'interventions': [{'name': 'abdominal binder', 'type': 'DEVICE', 'armGroupLabels': ['abdominal binder']}, {'name': 'no binder', 'type': 'OTHER', 'armGroupLabels': ['regular bandage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78232', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edward R. Kost, M.D.', 'investigatorAffiliation': 'Brooke Army Medical Center'}}}}