Wound ComplicationNCT01496404
Electrocautery Versus Scalpel for Skin Incisions
A study testing Electrocautery and Scalpel in people with Wound Complication and Surgical Wound Infection, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Wound Complication, Surgical Wound Infection, Post-operative Pain
- What is being tested?
- Electrocautery and Scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 19 years old
- bowel resection surgery
- incision is 3cm or larger
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions
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.
- Being tested
- Electrocautery, Scalpel
- Keywords
- Electrocautery
- Medical subject headings
- Surgical Wound Infection, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocauteryProcedure or surgery
Electrocautery using cutting mode of epidermis and dermis of skin.
ScalpelProcedure or surgery
Incising skin (epidermis and dermis) with scalpel.
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery | Experimental | Epidermis and dermis incised with cutting setting of electrocautery. Receives: Procedure: Electrocautery |
| Scalpel | Active comparator | Control, incision of epidermis and dermis with scalpel. Receives: Procedure: Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Wound Infection Rate
Superficial incisional surgical site infection as defined by the Centres for Disease Control (CDC).
Measured: 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.
Measured: within 5 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Carl J Brown, St. Paul's Hospital, Canada
- Investigators
- Carl J Brown, MD MSc FRCSC, Principal investigator, Providence Health, University of British ColumbiaLisa NF Aird, BSc MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496404
- Sponsor's protocol ID
- H11-02242
- Status last verified
- Jul 2014
- First submitted
- 18 Dec 2011
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25692789
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions
- ClinicalTrials.gov ID
- NCT01496404
- Acronym / sponsor ID
- H11-02242
- Keywords
- Electrocautery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery | Experimental | Procedure: ElectrocauteryEpidermis and dermis incised with cutting setting of electrocautery. |
| Scalpel | Active comparator | Procedure: ScalpelControl, incision of epidermis and dermis with scalpel. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 19 years old
- bowel resection surgery
- incision is 3cm or larger
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocauteryElectrocautery using cutting mode of epidermis and dermis of skin. | Procedure or surgery | Electrocautery |
| ScalpelIncising skin (epidermis and dermis) with scalpel. | Procedure or surgery | Scalpel |
Primary outcome
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.
2 secondary outcomes
Wound Infection Rate
Time frame: within 6 months post-operatively
Post-operative wound pain
Time frame: within 5 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Derived from this study: PubMed 25692789Aird 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Brown, MD MSc FRCSC principal investigator
Providence Health, University of British Columbia
Lisa NF Aird, BSc MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery and Scalpel in people with Wound Complication and Surgical Wound Infection, run by St. Paul's Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Cosmesis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.