Surgical IncisionNCT05471466
Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population
A study testing Surgical incision in people with Surgical Incision, run by CeLois Lawrence at 1 site in Jamaica.
Trial summary
This is randomized controlled double-blinded trial comparing the scar outcomes of diathermy versus scalpel surgical incisions in the neck. It was conducted in humans in an Afro-Caribbean (black) population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Surgical incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJamaica
- Study dates
- 21 Aug 2019to 25 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following are the conditions for inclusion in the study:
- Subjects must be 18 years of age or older and give written informed consent
- Treatment for surgical condition requires the type of neck incision that would be used for a standard thyroidectomy i.e. a horizontal incision about 2 fingers' breadth above the sternal notch or in a skin crease close to that landmark extending from the anterior border of one sternocleidomastoid muscle to another.
- Only elective surgical cases will be included
- Only primary incisions will be included i.e. no completion thyroidectomies or scar revisions to the neck
- Only clean surgeries will be included
- All wounds must be closed primarily i.e. no wounds healed by secondary intention or delayed primary closure or flap or graft coverage will be included
Who cannot join
- The following are conditions for exclusion from the study:
- Subjects with skin pathologies i.e. patients with dermatological conditions, skin infections, altered pigmentation to the neck, use of skin-lightening agents to the neck, or neurofibromatosis will be excluded.
- Surgeries requiring a drain (This is a relative exclusion criterion as subjects with drains that are pulled through skin outside of the incision site may be included. However, patient must consent to this prior).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population: A Randomized Controlled Trial
This is randomized controlled double-blinded trial comparing the scar outcomes of diathermy versus scalpel surgical incisions in the neck. It was conducted in humans in an Afro-Caribbean (black) population.
Read the detailed description
This double-blinded parallel group randomized controlled trial included consecutive eligible Ear, Nose and Throat (ENT) patients at a Jamaican tertiary hospital requiring an anterior neck incision. The purpose was to determine whether cutting diathermy adversely affected scar cosmesis in an Afro-Caribbean population and whether complexion influenced this outcome. Half of the incision in each of 35 patients was randomly assigned to either cutting electrocautery or scalpel. The patients and the assessor of the scars were blinded and the both sides of the scar were assessed by both parties using the patient component of the Patient and Observer Scar Assessment Score (PSAS) and the Vancouver Scar Scale (VSS) at 1 week, 3 months and 6 months postoperative intervals. The Fitzpatrick Phototyping Scale was used for skin pigmentation classification.
- Conditions
- Surgical Incision
- Being tested
- Surgical incision
- Keywords
- Skin Wound, Afro-Caribbean or black skin, Diathermy or electrosurgical unit, Neck surgery, Scalpel Wound
- Medical subject headings
- Surgical Wound, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical incisionProcedure or surgery
Surgical incisions to the neck as part of the management of the head and neck condition.
| Study group | Role | What they receive |
|---|---|---|
| Diathermy- Electrosurgical Unit Cutting Settings | Active comparator | One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode). Receives: Procedure: Surgical incision |
| Scalpel- Surgical Blade | Active comparator | One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade). Receives: Procedure: Surgical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between diathermy and scalpel scar cosmesis- Total PSAS.
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Total Patient Scar Assessment Score (PSAS) on a scale of 6 to 60 where 6 is as per normal skin and 60 is very different from normal skin. There were measured at 1 week, 3 months, and 6 months post-surgery.
Measured: Six months
Difference between diathermy and scalpel scar cosmesis- Overall PSAS.
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Overall Patient Scar Assessment Score (PSAS) on a scale of 1 to 10 where 1 is as per normal skin and 10 is very different from normal skin. These were measured at 1 week, 3 months, and 6 months post-surgery.
Measured: Six months
Difference between diathermy and scalpel scar cosmesis- VSS.
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Vancouver Scar Scale (VSS) on a scale of 0 to 13 where 0 is as per normal skin and 13 is the most extreme difference from normal skin. These were measured at 1 week, 3 months, and 6 months post-surgery.
Measured: Six months
Secondary outcomes (1)
Difference in scar cosmesis based on skin complexion.
Difference in scar cosmesis based on Fitzpatrick Phototyping category (skin complexion) on a scale of 1 to 6 where 1 is the lightest skin complexion and 6 is the darkest. This is as per the Total Patient Scar Assessment Score (PSAS), Overall PSAS and the Vancouver Scar Scale (VSS) measured at 1 week, 3 months, and 6 months post-surgery.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start21 Aug 2019
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double-blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeLois Lawrence
- Sponsor type
- University, hospital or other
- Collaborators
- The University of The West Indies
- Responsible party
- Sponsor-investigator, CeLois Lawrence, Kingston Public Hospital
- Investigators
- CeLois Lawrence, BSc MBBS, Principal investigator, Kingston Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471466
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data directly related to the research outcomes in the publication will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05471466
- Acronym / sponsor ID
- 1
- Conditions
- Surgical Incision
- Keywords
- Skin Wound, Afro-Caribbean or black skin, Diathermy or electrosurgical unit, Neck surgery, Scalpel Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CeLois LawrenceUniversity, hospital or other
- Collaborators
- The University of The West Indies
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 22 Jul 2022 (actual)
- 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.
This is randomized controlled double-blinded trial comparing the scar outcomes of diathermy versus scalpel surgical incisions in the neck. It was conducted in humans in an Afro-Caribbean (black) population.
Detailed description
This double-blinded parallel group randomized controlled trial included consecutive eligible Ear, Nose and Throat (ENT) patients at a Jamaican tertiary hospital requiring an anterior neck incision. The purpose was to determine whether cutting diathermy adversely affected scar cosmesis in an Afro-Caribbean population and whether complexion influenced this outcome. Half of the incision in each of 35 patients was randomly assigned to either cutting electrocautery or scalpel. The patients and the assessor of the scars were blinded and the both sides of the scar were assessed by both parties using the patient component of the Patient and Observer Scar Assessment Score (PSAS) and the Vancouver Scar Scale (VSS) at 1 week, 3 months and 6 months postoperative intervals. The Fitzpatrick Phototyping Scale was used for skin pigmentation classification.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled double-blinded
| Arm | Type | Receives |
|---|---|---|
| Diathermy- Electrosurgical Unit Cutting Settings | Active comparator | Procedure: Surgical incisionOne half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode). |
| Scalpel- Surgical Blade | Active comparator | Procedure: Surgical incisionOne half of the neck incision in each participant was made using a scalpel (size 10 surgical blade). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The following are the conditions for inclusion in the study:
Key exclusion criteria (3 listed)
- The following are conditions for exclusion from the study:
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 |
|---|---|---|
| Surgical incisionSurgical incisions to the neck as part of the management of the head and neck condition. | Procedure or surgery | Diathermy- Electrosurgical Unit Cutting Settings, Scalpel- Surgical Blade |
Primary outcome
Difference between diathermy and scalpel scar cosmesis- Total PSAS.
Time frame: Six months
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Total Patient Scar Assessment Score (PSAS) on a scale of 6 to 60 where 6 is as per normal skin and 60 is very different from normal skin. There were measured at 1 week, 3 months, and 6 months post-surgery.
Difference between diathermy and scalpel scar cosmesis- Overall PSAS.
Time frame: Six months
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Overall Patient Scar Assessment Score (PSAS) on a scale of 1 to 10 where 1 is as per normal skin and 10 is very different from normal skin. These were measured at 1 week, 3 months, and 6 months post-surgery.
Difference between diathermy and scalpel scar cosmesis- VSS.
Time frame: Six months
Difference in scar cosmesis between the diathermy and scalpel sides of the scar as assesses by the Vancouver Scar Scale (VSS) on a scale of 0 to 13 where 0 is as per normal skin and 13 is the most extreme difference from normal skin. These were measured at 1 week, 3 months, and 6 months post-surgery.
1 secondary outcome
Difference in scar cosmesis based on skin complexion.
Time frame: Six months
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 2022.
- Individual participant dataSharing planned: Yes. Individual patient data directly related to the research outcomes in the publication will be shared upon request.
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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.
CeLois Lawrence, BSc MBBS principal investigator
Kingston Public Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical incision in people with Surgical Incision, run by CeLois Lawrence at 1 site in Jamaica.
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 7 inclusion and 3 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 2022. 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 Jamaica. 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?
Difference between diathermy and scalpel scar cosmesis- Total PSAS. (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2022.