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Electrocautery Versus Scalpel for Skin Incisions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496404
First Posted: December 21, 2011
Last Update Posted: July 22, 2014
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.
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada
  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
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

Further study details as provided by Dr. Carl J Brown, St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 66
Study Start Date: January 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01496404


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: December 18, 2011
First Posted: December 21, 2011
Last Update Posted: July 22, 2014
Last Verified: July 2014

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

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


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