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OpenTrials
Completed

NCT Number: NCT01496404

Electrocautery Versus Scalpel for Skin Incisions

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.

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Key information

Conditions

Wound Complication Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrocautery

Procedure

Electrocautery using cutting mode of epidermis and dermis of skin.

Scalpel

Procedure

Incising skin (epidermis and dermis) with scalpel.

Primary outcomes

  1. Scar Cosmesis

    Time frame: 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 outcomes

  1. Wound Infection Rate

    Time frame: within 6 months post-operatively

    Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).

  2. Post-operative wound pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Paul's Hospital, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2011
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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