Electrocautery Versus Scalpel for Skin Incisions

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01496404

Enrollment

Registered

2011-12-21

Start date

2012-01-31

Completion date

2013-08-31

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Complication, Surgical Wound Infection, Post-operative Pain

Keywords

Electrocautery

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.

Interventions

PROCEDUREElectrocautery

Electrocautery using cutting mode of epidermis and dermis of skin.

PROCEDUREScalpel

Incising skin (epidermis and dermis) with scalpel.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Wound Infection Rate	within 6 months post-operatively	Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026