Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06400394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a randomised double blind placebo controlled parallel group study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SSI Incidence', 'timeFrame': '30 days', 'description': 'To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for perforated viscus.'}], 'secondaryOutcomes': [{'measure': 'CRP Level', 'timeFrame': '24-48 hrs', 'description': 'To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for perforated viscus'}, {'measure': 'Flatus time', 'timeFrame': '1-2 days', 'description': 'To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for perforated viscus.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['"Peritonitis" "Peritoneal lavage" "surgical site infection" "super-oxidised solution"'], 'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.\n\nThis is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study', 'detailedDescription': 'OBJECTIVES\n\nPrimaryOutcome:\n\nTo evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for peritonitis.\n\nSecondaryOutcome:\n\ni.To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for peritonitis ii.To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for peritonitis.\n\nMETHODOLOGY\n\nStudy Design This is a randomised double blind placebo controlled parallel group study. This is a superiority study assessing the effectiveness of the intervention. The patients and doctors directly involved in the patient care will be blinded in this study.\n\nMasking Study participants were randomly assigned following computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1. Allocation sequence and concealment will be performed by the research staff from the Clinical Research Centre who had no clinical involvement in the trial. The allocation sequence will be concealed from the researcher enrolling and assessing the participants in sequentially numbered, opaque, sealed envelopes.\n\nThe study participants, healthcare providers who attend to the participants during the trial (surgeon and nurses), outcome evaluators (surgical doctors and nurses) and data collectors will be blinded to the allocation.\n\n2 arms with 56 participants per arm Study group: Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml \\[Super-oxidised solution used in this study is Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia)\\] Control group: Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml\n\nEnrollment The estimated total number of participants to be enrolled is about 116 with 20% dropout rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients age 13yrs and above\n2. Diagnosed with perforated viscus intraoperatively\n3. Undergo Midline Laparotomy\n4. ASA 3 and below\n\nExclusion Criteria:\n\n1. Surgical technique: Laparoscopic washouts\n2. Patients on steroid treatment and immunosuppressant therapy.\n3. More than ASA 3\n4. Inability to give/understand informed consent\n5. Revision-surgery (previous abdominal surgery within the last 30 days)\n6. Planned re-laparotomy within 30 days\n7. Terminal kidney failure requiring dialysis\n8. Concurrent abdominal wall infections'}, 'identificationModule': {'nctId': 'NCT06400394', 'acronym': 'Plasso 2', 'briefTitle': 'Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'RSCH ID-24-01241-VGD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml', 'interventionNames': ['Device: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml', 'interventionNames': ['Device: Hydrocyn Aqua®']}], 'interventions': [{'name': 'Hydrocyn Aqua®', 'type': 'DEVICE', 'description': 'The study solution comes in a liquid form containing hypochlorous acid (HOCl) in a concentration of 0.003%. It is used as a topical agent for wound and peritoneal lavage before wound closure', 'armGroupLabels': ['Study group']}, {'name': 'Normal Saline', 'type': 'DEVICE', 'description': 'aqueous solution of electrolytes and other hydrophilic molecules', 'armGroupLabels': ['Control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Queen Elizabeth, Malaysia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dinesh Alagoo', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}