Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-04 @ 7:30 AM
Study NCT ID:
NCT05458518
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caesarean Wound Dressing Removal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cesarean wound complication', 'timeFrame': '30 days', 'description': 'Hematoma, seroma, wound infection, wound dehiscence'}], 'secondaryOutcomes': [{'measure': 'Pain control', 'timeFrame': '48 hours', 'description': 'Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)'}, {'measure': 'Self hygiene', 'timeFrame': '48 hours', 'description': 'Timing of first bath after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wound dressing', 'cesarean'], 'conditions': ['Surgical Wound', 'Surgical Wound Infection', 'Cesarean Section Complications']}, 'referencesModule': {'references': [{'pmid': '27018465', 'type': 'RESULT', 'citation': 'Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25.'}, {'pmid': '32312139', 'type': 'RESULT', 'citation': 'Kilic GS, Demirdag E, Findik MF, Tapisiz OL, Sak ME, Altinboga O, Sak S, Unlu BS, Evsen MS, Zeybek B, Borahay M, Kuo YF. Impact of timing on wound dressing removal after caesarean delivery: a multicentre, randomised controlled trial. J Obstet Gynaecol. 2021 Apr;41(3):348-352. doi: 10.1080/01443615.2020.1736015. Epub 2020 Apr 21.'}, {'pmid': '32202035', 'type': 'RESULT', 'citation': 'Tan PC, Rohani E, Lim M, Win ST, Omar SZ. A randomised trial of caesarean wound coverage: exposed versus dressed. BJOG. 2020 Sep;127(10):1250-1258. doi: 10.1111/1471-0528.16228. Epub 2020 Apr 16.'}, {'pmid': '32266018', 'type': 'RESULT', 'citation': 'Zhang T, Zhang F, Chen Z, Cheng X. Comparison of early and delayed removal of dressing following primary closure of clean and contaminated surgical wounds: A systematic review and meta-analysis of randomized controlled trials. Exp Ther Med. 2020 May;19(5):3219-3226. doi: 10.3892/etm.2020.8591. Epub 2020 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.', 'detailedDescription': "The trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour.\n\nThe primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) The secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-50\n2. Lower segment caesarean delivery\n3. Primary or repeat caesarean delivery\n4. Caesarean section in active phase of labour.\n5. Regional anaesthesia\n\nExclusion Criteria:\n\n1. Upper segment or classical caesarean delivery\n2. Massive postpartum haemorrhage \\> 1.5 litre\n3. Pre-delivery chorioamnionitis\n4. Skin closure using interrupted suture\n5. Acquired or congenital coagulation disorder\n6. Associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection.\n7. Inability to give consent'}, 'identificationModule': {'nctId': 'NCT05458518', 'acronym': 'Cesarean', 'briefTitle': 'Caesarean Wound Dressing Removal Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Kemaman'}, 'officialTitle': 'A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery', 'orgStudyIdInfo': {'id': 'NMRR ID-22-00321-NZM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dressing removal at 24 hours', 'description': 'The wound dressing will be removed 24 hours after emergency cesarean delivery', 'interventionNames': ['Procedure: Cesarean wound dressing removal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dressing removal at 48 hours', 'description': 'The wound dressing will be removed 48 hours after emergency cesarean delivery', 'interventionNames': ['Procedure: Cesarean wound dressing removal']}], 'interventions': [{'name': 'Cesarean wound dressing removal', 'type': 'PROCEDURE', 'description': 'The cesarean wound dressing is to be removed and the surgical wound exposed', 'armGroupLabels': ['Dressing removal at 24 hours', 'Dressing removal at 48 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24000', 'city': 'Kampong Kemaman', 'state': 'Terengganu', 'country': 'Malaysia', 'facility': 'Hospital Kemaman', 'geoPoint': {'lat': 4.23333, 'lon': 103.45}}], 'overallOfficials': [{'name': 'Zahar A Zakaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Kemaman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Kemaman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Head of Department, Lead Investigator', 'investigatorFullName': 'Zahar Azuar Zakaria', 'investigatorAffiliation': 'Hospital Kemaman'}}}}