Electrocautery Versus Scalpel for Skin Incisions
|ClinicalTrials.gov Identifier: NCT01496404|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : July 22, 2014
The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:
- To investigate whether electrocautery produces a cosmetically inferior surgical scar.
- To compare the rates of wound infection with each technique.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Wound Complication Surgical Wound Infection Post-operative Pain||Procedure: Electrocautery Procedure: Scalpel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Epidermis and dermis incised with cutting setting of electrocautery.
Electrocautery using cutting mode of epidermis and dermis of skin.
Active Comparator: Scalpel
Control, incision of epidermis and dermis with scalpel.
Incising skin (epidermis and dermis) with scalpel.
- Scar Cosmesis [ Time Frame: 6 months ]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.
- Wound Infection Rate [ Time Frame: within 6 months post-operatively ]Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
- Post-operative wound pain [ Time Frame: within 5 days post-operatively ]Patients will also be asked to record their daily post-operative incision pain using the visual analogue score (VAS) until post-operative day 5.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496404
|Canada, British Columbia|
|St Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Carl J Brown, MD MSc FRCSC||Providence Health, University of British Columbia|
|Principal Investigator:||Lisa NF Aird, BSc MD||University of British Columbia|