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Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population

Primary Purpose

Surgical Incision

Status
Completed
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Surgical incision
Sponsored by
CeLois Lawrence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Incision focused on measuring Skin Wound, Afro-Caribbean or black skin, Diathermy or electrosurgical unit, Neck surgery, Scalpel Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The following are the conditions for inclusion in the study:

    1. Subjects must be 18 years of age or older and give written informed consent
    2. 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.
    3. Only elective surgical cases will be included
    4. Only primary incisions will be included i.e. no completion thyroidectomies or scar revisions to the neck
    5. Only clean surgeries will be included
    6. 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

Exclusion Criteria:

  • The following are conditions for exclusion from the study:

    1. 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.
    2. 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).

Sites / Locations

  • Kingston Public Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diathermy- Electrosurgical Unit Cutting Settings

Scalpel- Surgical Blade

Arm Description

One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode).

One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 14, 2022
Last Updated
July 20, 2022
Sponsor
CeLois Lawrence
Collaborators
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT05471466
Brief Title
Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population
Official Title
Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CeLois Lawrence
Collaborators
The University of The West Indies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
Keywords
Skin Wound, Afro-Caribbean or black skin, Diathermy or electrosurgical unit, Neck surgery, Scalpel Wound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled double-blinded
Masking
ParticipantOutcomes Assessor
Masking Description
Neither the participants nor the outcomes assessor were aware of which side of the incision was made using the scalpel or the electrosurgical unit device.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diathermy- Electrosurgical Unit Cutting Settings
Arm Type
Active Comparator
Arm Description
One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode).
Arm Title
Scalpel- Surgical Blade
Arm Type
Active Comparator
Arm Description
One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade).
Intervention Type
Procedure
Intervention Name(s)
Surgical incision
Intervention Description
Surgical incisions to the neck as part of the management of the head and neck condition.
Primary Outcome Measure Information:
Title
Difference between diathermy and scalpel scar cosmesis- Total PSAS.
Description
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.
Time Frame
Six months
Title
Difference between diathermy and scalpel scar cosmesis- Overall PSAS.
Description
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.
Time Frame
Six months
Title
Difference between diathermy and scalpel scar cosmesis- VSS.
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Difference in scar cosmesis based on skin complexion.
Description
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CeLois Lawrence, BSc MBBS
Organizational Affiliation
Kingston Public Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Public Hospital
City
Kingston
Country
Jamaica

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual patient data directly related to the research outcomes in the publication will be shared upon request.
IPD Sharing Time Frame
The data will become available up to 2 years after the date of publication/ journal issue.

Learn more about this trial

Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population

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