Electrocautery Versus Scalpel for Skin Incisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496404
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : July 22, 2014
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada

Brief Summary:

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Wound Infection Rate [ Time Frame: within 6 months post-operatively ]
    Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496404

Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Carl J Brown, Head, Division of General Surgery, Providence Health Care, St. Paul's Hospital, Canada Identifier: NCT01496404     History of Changes
Other Study ID Numbers: H11-02242
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Dr. Carl J Brown, St. Paul's Hospital, Canada:

Additional relevant MeSH terms:
Wounds and Injuries
Pain, Postoperative
Wound Infection
Surgical Wound
Surgical Wound Infection
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms