Electrocautery Versus Scalpel for Skin Incisions

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Complication, Surgical Wound Infection, Post-operative Pain

Intervention / Treatment
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* Procedure: Electrocautery
* Procedure: Scalpel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrocautery<br>Epidermis and dermis incised with cutting setting of electrocautery. | Procedure: Electrocautery<br>* Electrocautery using cutting mode of epidermis and dermis of skin.<br>|
| Active Comparator: Scalpel<br>Control, incision of epidermis and dermis with scalpel. | Procedure: Scalpel<br>* Incising skin (epidermis and dermis) with scalpel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrocautery