Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07286851
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do Topical Antibiotics Improve Skin Graft Results?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009355', 'term': 'Neomycin'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-13', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative infection rate', 'timeFrame': "Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.", 'description': 'Whether patients had post-operative infection during their hospitalization, classified as "yes" or "no" as defined by any of the following being present: "post-operative infection" diagnosis written in the patient\'s medical record, change or increase in antibiotic therapy post-operatively, or the presence of pus documented at the skin graft site.'}], 'secondaryOutcomes': [{'measure': 'Skin graft take', 'timeFrame': "Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.", 'description': "Percentage of skin graft that remained intact at the time of discharge, as estimated by the treating surgeon and documented in the patient's record."}, {'measure': 'Need for operative re-intervention', 'timeFrame': 'From the time of operation until the end of the study period (up to three years for the earliest skin graft patients).', 'description': 'Whether patient needed to return to the operating room for additional procedures (such as debridement or repeat skin grafting) for the same wound, classified as "yes" or "no."'}, {'measure': 'Length of stay', 'timeFrame': "Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.", 'description': 'Number of days spent in the hospital during the initial post-operative period.'}, {'measure': 'Allergic reaction', 'timeFrame': "Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.", 'description': 'Whether patient had any allergic reaction to neomycin or any other substance documented - categorized as "yes" or "no," based on the new presentation of rash or pruritis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bangladesh', 'developing countries'], 'conditions': ['Skin Transplantation', 'Wounds and Injuries', 'Antibiotic Prophylaxis Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see if putting antibiotic ointment on a skin graft when the surgery is being done helps prevent the skin graft from getting infected after the operation. The study is looking at all skin grafts done in a rural Bangladesh hospital.\n\nThe main questions it aims to answer are:\n\nDoes the antibiotic lower the number of infections that happen? Does the antibiotic make the overall outcome of the skin graft better? Do patients who get the antibiotic need fewer extra surgeries?\n\nResearchers will compare the outcomes from patients who had skin grafts before the hospital started applying antibiotic ointment to the outcomes of patients after the hospital began applying antibiotic ointment.\n\nParticipants who have already had their skin graft treatment completed will have their medical records reviewed by researchers. The outcomes of their treatment will be written down.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with wounds undergoing split-thickness skin graft surgery at a single rural hospital in Bangladesh.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing a split-thickness skin graft at the hospital where research is conducted\n\nExclusion Criteria:\n\n* Missing or incomplete medical record'}, 'identificationModule': {'nctId': 'NCT07286851', 'briefTitle': 'Do Topical Antibiotics Improve Skin Graft Results?', 'organization': {'class': 'OTHER', 'fullName': 'LAMB Project'}, 'officialTitle': 'Effects of Topical Neomycin on Skin Graft Outcomes in Rural Bangladesh: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'REC2025/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Patients who had skin graft procedure before the topical antibiotic protocol was initiated'}, {'label': 'Neomycin', 'description': 'Patients who had skin graft procedure after the topical antibiotic protocol was initiated. Patients had topical neomycin applied at the time of their surgeries.', 'interventionNames': ['Drug: Neomycin']}], 'interventions': [{'name': 'Neomycin', 'type': 'DRUG', 'description': 'Topical neomycin was applied at the time of split-thickness skin graft surgery.', 'armGroupLabels': ['Neomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5250', 'city': 'Parbatipur', 'state': 'Dinajpur', 'country': 'Bangladesh', 'facility': 'LAMB Hospital', 'geoPoint': {'lat': 25.66369, 'lon': 88.93093}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'This IPD will be available beginning when the study is published and will be available while the authors continue to be affiliated with the institution where the study has taken place.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication may be available upon reasonable request if the study is published in a peer-reviewed journal.', 'accessCriteria': 'The request for sharing of data must be reviewed by the LAMB Project Research Ethics Committee, which will make all final decisions about the sharing of individual patient data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LAMB Project', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon, Deputy Medical Director', 'investigatorFullName': 'Jonathan Egle', 'investigatorAffiliation': 'LAMB Project'}}}}