Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT01496404
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2011-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrocautery Versus Scalpel for Skin Incisions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-19', 'studyFirstSubmitDate': '2011-12-18', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar Cosmesis', 'timeFrame': '6 months', 'description': "At 6 months post-operative, patients' scars will be evaluated by two independent trained blinded observers who will use the Patient Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale (VSS) to evaluate the cosmesis of the surgical scar. Patients, who are blinded to the type of incision they have received, will also subjectively assign a score to their scar using the POSAS."}], 'secondaryOutcomes': [{'measure': 'Wound Infection Rate', 'timeFrame': 'within 6 months post-operatively', 'description': 'Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).'}, {'measure': 'Post-operative wound pain', 'timeFrame': 'within 5 days post-operatively', 'description': 'Patients will also be asked to record their daily post-operative incision pain using the visual analogue score (VAS) until post-operative day 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Electrocautery'], 'conditions': ['Wound Complication', 'Surgical Wound Infection', 'Post-operative Pain']}, 'referencesModule': {'references': [{'pmid': '25692789', 'type': 'DERIVED', 'citation': 'Aird LN, Bristol SG, Phang PT, Raval MJ, Brown CJ. Randomized double-blind trial comparing the cosmetic outcome of cutting diathermy versus scalpel for skin incisions. Br J Surg. 2015 Apr;102(5):489-94. doi: 10.1002/bjs.9751. Epub 2015 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:\n\n1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.\n2. To compare the rates of wound infection with each technique.\n3. To determine if electrocautery results in less postoperative pain. Our null hypothesis is that electrocautery is equivalent to scalpel for creating skin incisions; with respect to wound cosmesis, wound infection rate, and post-operative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 19 years old\n* bowel resection surgery\n* incision is 3cm or larger\n\nExclusion Criteria:\n\n* Diagnosed with a connective tissue disease (e.g. Systemic lupus, scleroderma, polymyositis, dermatomyositis, Marfan syndrome, Ehler's Danlos, etc.)\n* The site of planned surgery has a previous surgical scar."}, 'identificationModule': {'nctId': 'NCT01496404', 'briefTitle': 'Electrocautery Versus Scalpel for Skin Incisions', 'organization': {'class': 'OTHER', 'fullName': "St. Paul's Hospital, Canada"}, 'officialTitle': 'A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions', 'orgStudyIdInfo': {'id': 'H11-02242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrocautery', 'description': 'Epidermis and dermis incised with cutting setting of electrocautery.', 'interventionNames': ['Procedure: Electrocautery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scalpel', 'description': 'Control, incision of epidermis and dermis with scalpel.', 'interventionNames': ['Procedure: Scalpel']}], 'interventions': [{'name': 'Electrocautery', 'type': 'PROCEDURE', 'description': 'Electrocautery using cutting mode of epidermis and dermis of skin.', 'armGroupLabels': ['Electrocautery']}, {'name': 'Scalpel', 'type': 'PROCEDURE', 'description': 'Incising skin (epidermis and dermis) with scalpel.', 'armGroupLabels': ['Scalpel']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Carl J Brown, MD MSc FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Health, University of British Columbia'}, {'name': 'Lisa NF Aird, BSc MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Paul's Hospital, Canada", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Division of General Surgery, Providence Health Care', 'investigatorFullName': 'Dr. Carl J Brown', 'investigatorAffiliation': "St. Paul's Hospital, Canada"}}}}