Electrocautery Versus Scalpel for Skin Incisions

Post-operative Pain Clinical Trial

Official title:

A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496404
• Other study ID #: H11-02242
• Status: Completed
• Phase: N/A
• First received: December 18, 2011
• Last updated: July 19, 2014
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: St. Paul's Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Surgical Wound Infection
• Wound Complication
• Wound Infection

Intervention

Procedure:
• Electrocautery
Electrocautery using cutting mode of epidermis and dermis of skin.
• Scalpel
Incising skin (epidermis and dermis) with scalpel.

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	Yes
Secondary	Wound Infection Rate	Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).	within 6 months post-operatively	Yes
Secondary	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.	within 5 days post-operatively	Yes