Electrocautery Versus Scalpel for Skin Incisions

July 19, 2014 updated by: Dr. Carl J Brown, St. Paul's Hospital, Canada

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Infection Rate
Time Frame: within 6 months post-operatively
Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
within 6 months post-operatively
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.
within 5 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 18, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 19, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-02242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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