Electrocautery Versus Scalpel for Skin Incisions

Not Applicable

Completed

• Conditions: Surgical Wound Infection; Post-operative Pain; Wound Complication
• Interventions: Procedure: Scalpel; Procedure: Electrocautery

• Registration Number: NCT01496404
• Lead Sponsor: St. Paul's Hospital, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Study Start: 2012-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-19
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scalpel	Scalpel	Control, incision of epidermis and dermis with scalpel.
Electrocautery	Electrocautery	Epidermis and dermis incised with cutting setting of electrocautery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

St Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada