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

Surgical Incision Clinical Trial

Official title:

Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471466
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: January 25, 2021

Study information

• Verified date: July 2022
• Source: Kingston Public Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hyperthermia
• Surgical Incision
• Surgical Wound

Intervention

Procedure:
• Surgical incision
Surgical incisions to the neck as part of the management of the head and neck condition.

Locations

Country	Name	City	State
Jamaica	Kingston Public Hospital	Kingston

Sponsors (2)

Lead Sponsor	Collaborator
CeLois Lawrence	The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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