Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT06339203
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2024-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite wound evaluation scale after caesarean delivery', 'timeFrame': 'Up to 8 weeks postop', 'description': 'Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cesarean Section Complications', 'Cesarean Section; Infection']}, 'descriptionModule': {'briefSummary': 'This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 or older\n* Singleton pregnancy\n* Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital\n* Planned post-operative follow up with Loma Linda OBGYN\n* Speak English or Spanish\n* At least one of the following medical complications: Obesity BMI\\>= 30kg/m2, Diabetes, Spontaneous rupture of membranes, Intraamniotic infection\n\nExclusion Criteria:\n\n* Emergency cesarean delivery"}, 'identificationModule': {'nctId': 'NCT06339203', 'briefTitle': 'Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)', 'orgStudyIdInfo': {'id': '5240002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irrisept', 'description': 'The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.', 'interventionNames': ['Device: Irrisept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Saline', 'description': 'The active comparator arm will receive the standard of care irrigation solution, normal saline, administered via standard pour over following the closure of the fascia in Cesarean section.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Irrisept', 'type': 'DEVICE', 'description': '450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water', 'armGroupLabels': ['Irrisept']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '450mL', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nikia Gray Hutto, AS', 'role': 'CONTACT', 'email': 'nhutto@llu.edu', 'phone': '909-558-4000', 'phoneExt': '44428'}], 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'centralContacts': [{'name': 'Nikia Gray-Hutto, AS', 'role': 'CONTACT', 'email': 'nhutto@llu.edu', 'phone': '9095584000', 'phoneExt': '44428'}, {'name': 'Ashra Denise Tugung, BS', 'role': 'CONTACT', 'email': 'atugung@llu.edu', 'phone': '9096515580'}], 'overallOfficials': [{'name': 'Ruofan Yao, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Irrimax Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}