Electrocautery Versus Scalpel for Skin Incisions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01496404
First received: December 18, 2011
Last updated: July 19, 2014
Last verified: July 2014

December 18, 2011
July 19, 2014
January 2012
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01496404 on ClinicalTrials.gov Archive Site
  • Wound Infection Rate [ Time Frame: within 6 months post-operatively ] [ Designated as safety issue: Yes ]
    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 ] [ 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.
  • 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.
Not Provided
Not Provided
 
Electrocautery Versus Scalpel for Skin Incisions
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions

The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:

  1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.
  2. To compare the rates of wound infection with each technique.
  3. 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Wound Complication
  • Surgical Wound Infection
  • Post-operative Pain
  • Procedure: Electrocautery
    Electrocautery using cutting mode of epidermis and dermis of skin.
  • Procedure: Scalpel
    Incising skin (epidermis and dermis) with scalpel.
  • Experimental: Electrocautery
    Epidermis and dermis incised with cutting setting of electrocautery.
    Intervention: Procedure: Electrocautery
  • Active Comparator: Scalpel
    Control, incision of epidermis and dermis with scalpel.
    Intervention: Procedure: Scalpel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 19 years old
  • bowel resection surgery
  • incision is 3cm or larger

Exclusion Criteria:

  • Diagnosed with a connective tissue disease (e.g. Systemic lupus, scleroderma, polymyositis, dermatomyositis, Marfan syndrome, Ehler's Danlos, etc.)
  • The site of planned surgery has a previous surgical scar.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01496404
H11-02242
No
Dr. Carl J Brown, St. Paul's Hospital, Canada
St. Paul's Hospital, Canada
Not Provided
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
St. Paul's Hospital, Canada
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP