Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT06302335
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not know what kind of substance will be used during the surgery.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days', 'description': 'Surgical site infection within 30 days from the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Intracavitary surgical infection', 'timeFrame': '30 days', 'description': 'Infections within the abdominal cavity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical site infection', 'colorectal surgey'], 'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.', 'detailedDescription': 'Patients will be randomized to one of the following intervention groups:\n\nGroup 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.\n\nNOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.\n\nRandomization: the block randomization method will be used (blocks of 4 patients each).\n\nGroups 1 and 2 will be compared with each other regarding the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology.\n\nExclusion Criteria:\n\n* age under 18;\n* surgery classified as dirty;\n* urgent/emergency surgery;\n* patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ);\n* known allergy to iodine.'}, 'identificationModule': {'nctId': 'NCT06302335', 'briefTitle': 'Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection', 'orgStudyIdInfo': {'id': '2022-0442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone-iodine arm', 'description': 'Patients submitted to colorectal resections using Povidone-iodine in the surgical wound.', 'interventionNames': ['Drug: Povidone-iodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline solution arm.', 'description': 'Patients submitted to colorectal resections using saline solution in the surgical wound.', 'interventionNames': ['Drug: Saline solution']}], 'interventions': [{'name': 'Povidone-iodine', 'type': 'DRUG', 'description': 'Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.', 'armGroupLabels': ['Povidone-iodine arm']}, {'name': 'Saline solution', 'type': 'DRUG', 'description': 'Application of saline solution to the surgical wound of patients submitted to colorectal resections.', 'armGroupLabels': ['Saline solution arm.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90.035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Daniel C Damin', 'role': 'CONTACT', 'email': 'damin@terra.com.br', 'phone': '+5551996020442'}], 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Daniel C Damin, PhD', 'role': 'CONTACT', 'email': 'damin@terra.com.br', 'phone': '+5551996020442'}], 'overallOfficials': [{'name': 'Daniel C Damin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}