Keloid keloid scar
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - Diagnosed with keloid disease (A keloid is defined as a well-demarcated area of fibrous tissue overgrowth which extends over the margins of the original injury) - Keloid size must be 1.5cm in length or more
Exclusion criteria
Exclusion criteria: - Known (neurological) conditions that affect the sensation such as diabetes mellitus and neuropathy regardless of cause - Patients with eczema or psoriasis within a 5 cm margin of their keloids - Keloids smaller than 1.5cm - Bilateral keloids on the same location, causing lack of control area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the sensibility of keloid (measured by SWM, PSSD and QST). Results will be compared between patients with versus patients without substantial clinical symptoms of pain and/or itch. All patients who are followed-up at the outpatient scar clinic fill in the Patient and Observer Scar Assessment Scale (POSAS) at each visit. The POSAS also evaluates pain and itch on a VAS of 1-10. Previous studies definied a score of 3 or more as substantial. For the SWM monofilaments, the thinnest monofilament value that was identified by the participant will be used for analysis. Means and standard deviations will be calculated for the entire cohort, both for keloid skin and control skin, as for the clinical subgroups. For the PSSD measurements, the mean of 3 measurements will be calculated and used for statistical analysis. Means and standard deviations will be calculated for the entire cohort, both for keloid skin and control skin, as for the clinical subgroups. For the QST, we will perform measurements to determine cold detection threshold (CDT), cold pain threshold (CPT), warmth detection threshold (WDT) and heat pain threshold (HPT). For each threshold, we will also perform the measurements 3 times and calculate the mean to use for statistical analysis. Then means and standard deviations will be calculated for the entire cohort, both for keloid skin and control skin, as for the clinical subgroups. Between-group differences will be tested using univariable linear regression analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome that will be evaluated will be the sensibility (measured by SWM, PSSD and QST), compared between keloid skin and control skin. All patients will undergo sensory testing of the keloid and normal unaffected skin on the contralateral side. In case of keloid location in the midline, the healthy skin in the dermatoma inferior to the keloid will be used as control. The paired-sample t-test will be used to investigate whether there is a difference in sensibility between keloid and control skin within patients For all sensory tests and comparison groups (substantial clinical symptoms versus no substantial clinical symptoms and keloid versus controle skin), adjusted between-group differences will be computed using multivariable linear regression analysis, in which potential confounding variables will be added as covariates in the model. The following study parameters that will be measured as possible confounders are - Age of patient - Gender - Location of keloid (face, ears, chest, shoulders, abdomen, limbs) - Age of keloid - Skin type - Previous treatment (type, timing and duration) Additionally, abovementioned univariable and multivariable linear regression analyses will be repeated using itch and pain scores as continuous variables, instead of dichotomizing into substantial itch and pain. | — |
Countries
Netherlands
Outcome results
None listed