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

NCT ID: NCT05471466

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2021-01-25

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.

Conditions

Surgical Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Surgical incision

Intervention Type: PROCEDURE

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

Scalpel- Surgical Blade

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

Group Type: ACTIVE_COMPARATOR

Surgical incision

Intervention Type: PROCEDURE

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

Interventions

Surgical incision

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of The West Indies

OTHER

Sponsor Role: collaborator

CeLois Lawrence

OTHER

Sponsor Role: lead

Responsible Party

CeLois Lawrence

Senior Resident- Department of Ear, Nose and Throat

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

CeLois Lawrence, BSc MBBS

Role: PRINCIPAL_INVESTIGATOR

Kingston Public Hospital

Locations

Kingston Public Hospital

Kingston, , Jamaica

Countries

Jamaica

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id