An interventional study of Surgical incision in Surgical Incision, sponsored by CeLois Lawrence. Completed at 1 site in Jamaica. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by CeLois Lawrence · Not applicable, Interventional, and Other
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's enrollment of 35 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →This is the only study on the registry with CeLois Lawrence as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following are the conditions for inclusion in the study:
Exclusion Criteria:
The following are conditions for exclusion from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One half of the neck incision in each participant was made using diathermy (electrosurgical unit cutting settings at 15 watts Blend One mode).
Procedure: Surgical incision
One half of the neck incision in each participant was made using a scalpel (size 10 surgical blade).
Procedure: Surgical incision
Surgical incisions to the neck as part of the management of the head and neck condition.
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.
Time frame: 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.
Time frame: 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.
Time frame: Six months
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.
Time frame: Six months
Plan to share: Yes — Individual patient data directly related to the research outcomes in the publication will be shared upon request.
Supporting information: Study protocol, Informed consent form
Time frame: The data will become available up to 2 years after the date of publication/ journal issue.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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