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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Incision
• Intervention / Treatment: Procedure: Surgical incision

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jamaica
  • Kingston, Jamaica
    • Kingston Public Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diathermy- Electrosurgical Unit Cutting Settings; One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode).	Procedure: Surgical incision; Surgical incisions to the neck as part of the management of the head and neck condition.
ACTIVE_COMPARATOR: Scalpel- Surgical Blade; One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade).	Procedure: Surgical incision; Surgical incisions to the neck as part of the management of the head and neck condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Collaborators and Investigators

• Sponsor: CeLois Lawrence
• Collaborators: The University of The West Indies
• Investigators: Principal Investigator: CeLois Lawrence, BSc MBBS, Kingston Public Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2019
• Primary Completion (ACTUAL): January 25, 2021
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (ACTUAL): July 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Neck surgery; Skin Wound; Afro-Caribbean or black skin; Diathermy or electrosurgical unit; Scalpel Wound
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Surgical Wound; Hyperthermia
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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