NCT01496404

Brief Summary

The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:

  1. 1.To investigate whether electrocautery produces a cosmetically inferior surgical scar.
  2. 2.To compare the rates of wound infection with each technique.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

December 18, 2011

Last Update Submit

July 19, 2014

Conditions

Wound ComplicationSurgical Wound InfectionPost-operative Pain

Keywords

Electrocautery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Wound Infection Rate

    within 6 months post-operatively

  • Post-operative wound pain

    within 5 days post-operatively

Study Arms (2)

Electrocautery

EXPERIMENTAL

Epidermis and dermis incised with cutting setting of electrocautery.

Procedure: Electrocautery

Scalpel

ACTIVE COMPARATOR

Control, incision of epidermis and dermis with scalpel.

Procedure: Scalpel

Interventions

ElectrocauteryPROCEDURE

Electrocautery using cutting mode of epidermis and dermis of skin.

Electrocautery
ScalpelPROCEDURE

Incising skin (epidermis and dermis) with scalpel.

Scalpel

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 19 years old
  • bowel resection surgery
  • incision is 3cm or larger

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25692789DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionPain, Postoperative

Interventions

ElectrocoagulationLaser Therapy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Carl J Brown, MD MSc FRCSC

    Providence Health, University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Lisa NF Aird, BSc MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of General Surgery, Providence Health Care

Study Record Dates

First Submitted

December 18, 2011

First Posted

December 21, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

CA(1)