Electrocautery Versus Scalpel for Skin Incisions

Sponsor

St. Paul's Hospital, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT01496404

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Complication Surgical Wound Infection Post-operative Pain	Procedure: Electrocautery Procedure: Scalpel	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Scar Cosmesis [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 [within 6 months post-operatively]
Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
Post-operative wound pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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