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Electrocautery Versus Scalpel for Skin Incisions

Primary Purpose

Wound Complication, Surgical Wound Infection, Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electrocautery
Scalpel
Sponsored by
St. Paul's Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Complication focused on measuring Electrocautery

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrocautery

Scalpel

Arm Description

Epidermis and dermis incised with cutting setting of electrocautery.

Control, incision of epidermis and dermis with scalpel.

Outcomes

Primary Outcome Measures

Scar Cosmesis
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
Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
Post-operative wound pain
Patients will also be asked to record their daily post-operative incision pain using the visual analogue score (VAS) until post-operative day 5.

Full Information

First Posted
December 18, 2011
Last Updated
July 19, 2014
Sponsor
St. Paul's Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01496404
Brief Title
Electrocautery Versus Scalpel for Skin Incisions
Official Title
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul's Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives: To investigate whether electrocautery produces a cosmetically inferior surgical scar. To compare the rates of wound infection with each technique. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Complication, Surgical Wound Infection, Post-operative Pain
Keywords
Electrocautery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrocautery
Arm Type
Experimental
Arm Description
Epidermis and dermis incised with cutting setting of electrocautery.
Arm Title
Scalpel
Arm Type
Active Comparator
Arm Description
Control, incision of epidermis and dermis with scalpel.
Intervention Type
Procedure
Intervention Name(s)
Electrocautery
Intervention Description
Electrocautery using cutting mode of epidermis and dermis of skin.
Intervention Type
Procedure
Intervention Name(s)
Scalpel
Intervention Description
Incising skin (epidermis and dermis) with scalpel.
Primary Outcome Measure Information:
Title
Scar Cosmesis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wound Infection Rate
Description
Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
Time Frame
within 6 months post-operatively
Title
Post-operative wound pain
Description
Patients will also be asked to record their daily post-operative incision pain using the visual analogue score (VAS) until post-operative day 5.
Time Frame
within 5 days post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Brown, MD MSc FRCSC
Organizational Affiliation
Providence Health, University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa NF Aird, BSc MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25692789
Citation
Aird LN, Bristol SG, Phang PT, Raval MJ, Brown CJ. Randomized double-blind trial comparing the cosmetic outcome of cutting diathermy versus scalpel for skin incisions. Br J Surg. 2015 Apr;102(5):489-94. doi: 10.1002/bjs.9751. Epub 2015 Feb 18.
Results Reference
derived

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Electrocautery Versus Scalpel for Skin Incisions

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