Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 4:39 PM
Study NCT ID:
NCT01584128
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2012-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2012-04-21', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vaginal cuff complications', 'timeFrame': 'postoperative', 'description': 'Incidence of vaginal cuff complicationsincluding vaginal cuff dehiscence, vaginal cuff cellulitis, and vaginal cuff abscess'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vaginal Cuff Complications']}, 'descriptionModule': {'briefSummary': 'The goal of the investigators study is to determine whether the use of oxidized regenerated cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy.', 'detailedDescription': 'Structured non-woven absorbable hemostat (or oxidized regenerated cellulose) was designed and marketed for its hemostatic properties. It is used in our practice to achieve hemostasis at the site of the vaginal cuff closure during laparoscopic hysterectomy. While the hemostatic properties of oxidized regenerated cellulose are well known and documented, there is newer research to suggest that oxidized regenerated cellulose may have antimicrobial activity. One In vitro study investigated the antimicrobial activity of oxidized regenerated cellulose products against multiple antibiotic resistant microorganisms and found that the antimicrobial affect of the oxidized regenerated cellulose products was significantly greater than that of the controls. There are a limited number of studies investigating the antimicrobial activity of oxidized regenerated cellulose products in vivo (and none in gynecologic surgery).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women, age 20-80, undergoing laparoscopic hysterectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female, ages 20-80, undergoing laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* malignant indications for hysterectomy'}, 'identificationModule': {'nctId': 'NCT01584128', 'briefTitle': 'Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Use of Structured Non-woven Absorbable Hemostat (or Oxidized Regenerated Cellulose) to Decrease Vaginal Cuff Dehiscence Rate in Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': '38775EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oxidized regenerated cellulose', 'description': 'Patients undergoing laparoscopic hysterectomy who have oxidized regenerated cellulose placed at the vaginal cuff at the time of their surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Carrie A Hossler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}