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

Not Applicable

Completed

• Conditions: Surgical Incision
• Interventions: Procedure: Surgical incision

• Registration Number: NCT05471466
• Lead Sponsor: CeLois Lawrence

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.

Study Timeline

• Study Start: 2019-08-21
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scalpel- Surgical Blade	Surgical incision	One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade).
Diathermy- Electrosurgical Unit Cutting Settings	Surgical incision	One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode).

Primary Outcome Measures

Name	Time	Method
Difference between diathermy and scalpel scar cosmesis- VSS.	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.
Difference between diathermy and scalpel scar cosmesis- Total PSAS.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Difference in scar cosmesis based on skin complexion.	Six months	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.

Trial Locations

Locations (1)

Kingston Public Hospital; 🇯🇲 Kingston, Jamaica