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| Name | Class |
|---|---|
| The University of The West Indies | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Scalpel- Surgical Blade | Active Comparator | One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical incision | Procedure | Surgical incisions to the neck as part of the management of the head and neck condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
The following are the conditions for inclusion in the study:
Exclusion Criteria:
The following are conditions for exclusion from the study:
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| Name | Affiliation | Role |
|---|---|---|
| CeLois Lawrence, BSc MBBS | Kingston Public Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Public Hospital | Kingston | Jamaica |
Individual patient data directly related to the research outcomes in the publication will be shared upon request.
The data will become available up to 2 years after the date of publication/ journal issue.
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D005334 | Fever |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized controlled double-blinded
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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.