Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 8:33 PM
Study NCT ID:
NCT06870695
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Intraoperatively', 'description': 'Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '3 days after surgery', 'description': 'Degree of pain will be measured using a standard 10-point visual analog pain scale (VAS). The women verbally reported a pain rating for each breast first in the recovery room (within 4 hours of surgical stop) and again at the first follow-up visit (1 to 3 days after surgery).'}, {'measure': 'De-epithelization time', 'timeFrame': 'Intraoperatively', 'description': 'De-epithelization time will be recorded.'}, {'measure': 'Time to achieve hemostasis', 'timeFrame': 'Intraoperatively', 'description': 'The time to achieve hemostasis will be assessed.'}, {'measure': 'Duration of drain placement', 'timeFrame': 'Intraoperatively', 'description': 'Duration of drain placement will be recorded.'}, {'measure': 'Blood loss', 'timeFrame': 'Intraoperatively', 'description': 'Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.'}, {'measure': 'Wound healing time', 'timeFrame': '6 weeks after surgery', 'description': 'Wound healing time will be recorded.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '6 weeks after surgery', 'description': 'The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety', 'Efficiency', 'Electrocautery', 'De-Epithelization', 'Mammoplasty']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.', 'detailedDescription': 'Mammoplasty is the fifth most commonly performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia.\n\nOne of the key stages in a breast reduction or augmentation surgery is the de-epithelization process. De-epithelialization is the first stage of reduction mammoplasty in techniques that use dermal, dermo-glandular pedicles. Traditional methods of de-epithelization include manual dissection or mechanical scraping as time-consuming and demanding by most surgeons, especially when the breasts are large and when there is no assistant available.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study was conducted on 100 females patients aged 18 years or older who were scheduled to undergo mammoplasty at Tanta University Hospitals, Egypt between July 2024 and February 2025', 'genderDescription': 'Women undergoing mammoplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients undergoing mammoplasty.\n\nExclusion Criteria:\n\n* Patients with active infections or open wounds at the surgical site.\n* Individuals with known hypersensitivity or adverse reactions to electrocautery.\n* Pregnant or lactating women.\n* Patients with uncontrolled diabetes or coagulation disorders.\n* History of psychiatric illness.\n* Patients undergoing secondary or repeat breast reduction procedures.'}, 'identificationModule': {'nctId': 'NCT06870695', 'briefTitle': 'Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty', 'orgStudyIdInfo': {'id': '36264PR1061/1/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Electrocautery group', 'description': 'Patients undergoing standard surgical de-epithelization with electrocautery.', 'interventionNames': ['Procedure: Electrocautery']}, {'label': 'Control group', 'description': 'Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.', 'interventionNames': ['Procedure: Surgical blade by scalpel']}], 'interventions': [{'name': 'Electrocautery', 'type': 'PROCEDURE', 'description': 'Patients undergoing standard surgical de-epithelization with electrocautery.', 'armGroupLabels': ['Electrocautery group']}, {'name': 'Surgical blade by scalpel', 'type': 'PROCEDURE', 'description': 'Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be available upon a reasonable request from the corresponding author.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'After the end of study for one year.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Plastic and Reconstructive Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohamed Hamdy Elghazaly', 'investigatorAffiliation': 'Tanta University'}}}}