Electrocautery Versus Scalpel for Skin Incisions
This study is not yet open for participant recruitment.
Verified December 2011 by St. Paul's Hospital, Canada
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada
First received: December 18, 2011
Last updated: December 20, 2011
Last verified: December 2011
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.
Surgical Wound Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions|
Resource links provided by NLM:
Further study details as provided by St. Paul's Hospital, Canada:
Primary Outcome Measures:
- Scar Cosmesis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Wound Infection Rate [ Time Frame: within 6 months post-operatively ] [ Designated as safety issue: Yes ]Superficial incisional surgical site infection as defined by the CDC.
- Post-operative wound pain [ Time Frame: within 5 days post-operatively ] [ Designated as safety issue: Yes ]Patients will also be asked to record their daily post-operative incision pain using the visual analogue score (VAS) until post-operative day 5.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496404
|Canada, British Columbia|
|St Paul's Hospital||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Contact: Carl J Brown, MD MSc FRCSC 604-806-8711 ext 2 CBrown@providencehealth.bc.ca|
|Principal Investigator: Lisa NF Aird, BSc MD|
|Principal Investigator: Carl J Brown, MD MSc FRCSC|
Sponsors and Collaborators
St. Paul's Hospital, Canada
|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|