Electrocautery Versus Scalpel for Skin Incisions

NCT ID: NCT01496404

Last Updated: 2014-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Complication Surgical Wound Infection Post-operative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Electrocautery

Epidermis and dermis incised with cutting setting of electrocautery.

Group Type EXPERIMENTAL

Electrocautery

Intervention Type PROCEDURE

Electrocautery using cutting mode of epidermis and dermis of skin.

Scalpel

Control, incision of epidermis and dermis with scalpel.

Group Type ACTIVE_COMPARATOR

Scalpel

Intervention Type PROCEDURE

Incising skin (epidermis and dermis) with scalpel.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocautery

Electrocautery using cutting mode of epidermis and dermis of skin.

Intervention Type PROCEDURE

Scalpel

Incising skin (epidermis and dermis) with scalpel.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Paul's Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Carl J Brown

Head, Division of General Surgery, Providence Health Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carl J Brown, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Providence Health, University of British Columbia

Lisa NF Aird, BSc MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25692789 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H11-02242

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery
NCT07078669 ENROLLING_BY_INVITATION NA
Undermining Apices in Surgical Wounds
NCT05758181 ENROLLING_BY_INVITATION NA