Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-09 @ 6:45 PM
Study NCT ID:
NCT04744961
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2021-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], '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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing mean values of SCAR-Q scores in both groups', 'timeFrame': '3 months', 'description': 'Scar-Q (http://qportfolio.org/scar-q/) is a patient reported outcome instrument in which scars will be assessed in terms of scar appearance and psychosocial impact. Scores will range from 0 (worst) to 100 (best). Scores will be compared between the two groups using either parametric or non-parametric tests depending on the distribution of the results.'}], 'secondaryOutcomes': [{'measure': 'Association between patient characteristics and SCAR-Q scores', 'timeFrame': '3 months', 'description': 'Score values (0-100) will be correlated to the following patient characteristics (gender, age, type of surgical procedure, anatomic location, and diagnosis of excised lesion)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. All patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. Results will be compared between the groups.", 'detailedDescription': '65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using SCAR-Q questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All included patients had a surgical procedure performed at our department. One group had documented surgical site infections and the other didn't.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020.\n\nExclusion Criteria:\n\n* Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04744961', 'briefTitle': 'Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery', 'orgStudyIdInfo': {'id': 'RegionSkane2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical site infections', 'interventionNames': ['Other: SCAR-Q survey']}, {'label': 'Normal would healing', 'interventionNames': ['Other: SCAR-Q survey']}], 'interventions': [{'name': 'SCAR-Q survey', 'type': 'OTHER', 'description': 'Telephone survey', 'armGroupLabels': ['Normal would healing', 'Surgical site infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of dermatology, Skåne university hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, M.D, Ph.D', 'investigatorFullName': 'Karim Saleh', 'investigatorAffiliation': 'Region Skane'}}}}