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Electrocautery Versus Scalpel for Skin Incisions

This study is not yet open for participant recruitment.
Verified December 2011 by St. Paul's Hospital, Canada
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: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.

Condition Intervention
Wound Complication
Surgical Wound Infection
Post-operative Pain
 Procedure: Electrocautery
Procedure: Scalpel

Study Type: Interventional
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:

MedlinePlus related topics: Scars
U.S. FDA Resources

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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
Experimental: Electrocautery
Epidermis and dermis incised with cutting setting of electrocautery.
 Procedure: Electrocautery
Electrocautery using cutting mode of epidermis and dermis of skin.
Active Comparator: Scalpel
Control, incision of epidermis and dermis with scalpel.
 Procedure: Scalpel
Incising skin (epidermis and dermis) with scalpel.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496404

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Carl J Brown, Head, Division of General Surgery, Providence Health Care, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01496404     History of Changes
Other Study ID Numbers: H11-02242
Study First Received: December 18, 2011
Last Updated: December 20, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Paul's Hospital, Canada:
Electrocautery

Additional relevant MeSH terms:
Pain, Postoperative
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
 Pain
Signs and Symptoms
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013