NCT05471466

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: CeLois Lawrence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Surgical incision	Surgical incisions to the neck as part of the management of the head and neck condition.

Timeline

• Start date: 2019-08-21
• Primary completion: 2021-01-25
• Completion: 2021-01-25
• First posted: 2022-07-22
• Last updated: 2022-07-22

Locations

1 site across 1 country: Jamaica