Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05289232
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2022-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Complications of Suture in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-13', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-12', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sutures complications after discharge of the Emergency Department PART 1', 'timeFrame': '15 days after the suture', 'description': 'After discharge from ED , patients were called back in order to know other informations about the patient and about the wound : its location,its dimension,the edges of the wound ,if its bleedong before suture ,and other factors that can facilitate its complications . the evolution of the wound, the adherence to the instructions and the prescriptions, the quality of healing and the search for complications'}], 'secondaryOutcomes': [{'measure': 'Sutures complications after discharge of the Emergency Department PART 2', 'timeFrame': '45 days after the suture', 'description': 'the patients were asked about the evolution of the wound,the appearence of complications such as disunity of stitches ,infection,delayed healing, necrosis, subcutaneous hematoma and about the adherence to the instructions and the prescriptionsgiven at discharge .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['suture', 'complications'], 'conditions': ['Suture, Complication']}, 'descriptionModule': {'briefSummary': 'included patients who had sutured wounds in the ED were asked about complications after suture .', 'detailedDescription': 'All patients using the emergency room of EPS Fattouma Bourguiba Monastir are welcomed by a resident in the suture room. After an inclusion, patients are cared for in the outpatient circuit and the suture will be done in the dedicated box. Before discharging the patient, instructions and standardized prescriptions are given to the patient such as standard prescriptions for local wound care, removal of stitches and verification of vaccination status.\n\nThe data relevant to this study are obtained prospectively from a detailed questionnaire in the annex and a telephone call and they are completed retrospectively with the data collected in the computerized medical record.\n\nAt the healing period, between 15 days and 45 days after the suture, the investigators called the patients back in order to know the evolution of the wound, the adherence to the instructions and the prescriptions, the quality of healing and the search for complications (infection , loose stitches, hematoma, etc.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Included patients presented to the outpatient emergency circuit of the EPS Fattouma Bourguiba Monastir having as main reason for consultation an acute suturable wound. The patients excluded are those who consulted for wounds requiring surgical treatment, septic wounds and patients who did not consent to the protocol.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute suturable wound\n\nExclusion Criteria:\n\nWounds requiring surgical treatment Septic wounds Chronic lesions Vascular wounds Patients who did not consent to the protocol.'}, 'identificationModule': {'nctId': 'NCT05289232', 'briefTitle': 'Prevalence and Complications of Suture in the ED', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Prevalence of Complications Post Sutured Wounds in the ED', 'orgStudyIdInfo': {'id': 'suture'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Monastir ,Tunisia', 'country': 'Tunisia', 'facility': 'Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir, Tunisia, 5000', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}