Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05632705
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessor will not have information with regards to the intervention arms'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy to reduce surgical site infections within seven days', 'timeFrame': 'Seven days post-operatively', 'description': 'Incidence of surgical site infections in both arms'}], 'secondaryOutcomes': [{'measure': 'Efficacy to reduce postpartum endometritis within seven days', 'timeFrame': 'Seven days post-operatively', 'description': 'Incidence of postpartum endometritis in both arms'}, {'measure': 'Feasibility of using a closure pack', 'timeFrame': 'At the time of caesarean section', 'description': 'Assess the availability as well as use of the sterile closing pack'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Postpartum Sepsis']}, 'descriptionModule': {'briefSummary': 'Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis', 'detailedDescription': 'Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients who are pregnant undergoing caesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women 18 years and older willing and able to provide consent\n\nExclusion Criteria:\n\n* women who are not able or willing to provide consent patients with existing maternal infection'}, 'identificationModule': {'nctId': 'NCT05632705', 'briefTitle': 'Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pretoria'}, 'officialTitle': 'A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section', 'orgStudyIdInfo': {'id': 'PPS trial 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'In this arm, prior to closing the sheath and skin, unused drapes, gloves and instruments will be used to close the sheath and the skin.', 'interventionNames': ['Other: Closing pack']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'In this arm sheath and skin closure will be according to the standard protocol'}], 'interventions': [{'name': 'Closing pack', 'type': 'OTHER', 'description': 'A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Kalafong Provincial Tertiary Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pretoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Leon Snyman', 'investigatorAffiliation': 'University of Pretoria'}}}}