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

NCT05471466 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision

Keywords

Skin Wound; Afro-Caribbean or black skin; Diathermy or electrosurgical unit; Neck surgery; Scalpel Wound

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Difference in scar cosmesis based on skin complexion.

  Six months

Study Arms (2)

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).

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).

Procedure: Surgical incision

Interventions

Surgical incision PROCEDURE

Surgical incisions to the neck as part of the management of the head and neck condition.

Diathermy- Electrosurgical Unit Cutting Settings; Scalpel- Surgical Blade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CeLois Lawrence: lead
• The University of The West Indies: collaborator

Study Sites (1)

Kingston Public Hospital

Kingston, Jamaica

Location

MeSH Terms

Conditions

Surgical Wound; Fever

Condition Hierarchy (Ancestors)

Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CeLois Lawrence, BSc MBBS

  Kingston Public Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Resident- Department of Ear, Nose and Throat

Model Details: Randomized controlled double-blinded

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 22, 2022
• Study Start: August 21, 2019
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will become available up to 2 years after the date of publication/ journal issue.

Locations

JA (1)