Clinical trial NCT05471466: Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population
Official title: Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Keywords: Skin Wound
Afro-Caribbean or black skin
Diathermy or electrosurgical unit
Neck surgery
Scalpel Wound
Lead sponsor: Kingston Public Hospital
Sponsor class: OTHER
Collaborators: name: The University of The West Indies
First posted: 2022-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double-blinded
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Difference between diathermy and scalpel scar cosmesis- Total PSAS.
timeFrame: Six months
measure: Difference between diathermy and scalpel scar cosmesis- Overall PSAS.
timeFrame: Six months
measure: Difference between diathermy and scalpel scar cosmesis- VSS.
timeFrame: Six months
Secondary outcomes:
measure: Difference in scar cosmesis based on skin complexion.
timeFrame: Six months
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Kingston Public Hospital
Study officials:
affiliation: Kingston Public Hospital
name: CeLois Lawrence, BSc MBBS
role: PRINCIPAL_INVESTIGATOR
References: