No registrations found.
ID
Source
Brief title
Health condition
Keloid, Hypertrophic scar
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibilty of new medical device (validity compared to standard device (Cutometer), duration of measurement, failed measurements, hypothetical) willingness of subjects to undergo again)
Secondary outcome
Epidermal thickness
Background summary
Stiffness and elasticity are important parameters in skin research and clinical practice. These biomechanical factors are affected by both physiological and pathological changes, of which scarring is the most common cause. Increased stiffness in scars is a major part of the disease burden in the case of hypertrophic scarring and keloids(1), and is therefore a target for multiple therapies aimed at decreasing stiffness and increasing elasticity. Objective quantification of the biomechanical characteristics of skin may be improved by a multimodal approach: by combining suction-based deformation with Optical Coherence Tomography imaging. This combination will be tested in this research project.
Study objective
Feasiblity study for new medical device
Study design
1 timepoint, potential subjects are asked to participate after their scheduled outpatient appointment. If subjects are willing to participate, primary and secondary outcomes are assessed by measurement with new device (OCE elastometer), old device (Cutometer), and subjects are asked to fill in Patient scale of the Patient and observer scale assessment scale (POSAS). A comparison of the two devices will be made. Validity of the new device will be made by comparing to stiffness item of the POSAS
Intervention
Measurement with new medical device
Inclusion criteria
Age: 18 years or older
Competent
De novo keloid/hypertrophic scar or follow up for keloid/hypertrophic scar treatment
(regardless of treatment modality)
Exclusion criteria
Language barrier
Immature scar, other scar types (hypertrophic, normotrophic)
Connective tissue disorders (e.g. Marfan, Ehlers Danlos, Cutis Laxa)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9829 |
Other | METC VUMC : 2021.0162 |