Feasiblity study for new medical device
ID
Bron
Verkorte titel
Aandoening
Keloid, Hypertrophic scar
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibilty of new medical device (validity compared to standard device (Cutometer), duration of measurement, failed measurements, hypothetical) willingness of subjects to undergo again)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Feasiblity study for new medical device
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Measurement with new medical device
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age: 18 years or older
Competent
De novo keloid/hypertrophic scar or follow up for keloid/hypertrophic scar treatment
(regardless of treatment modality)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Language barrier
Immature scar, other scar types (hypertrophic, normotrophic)
Connective tissue disorders (e.g. Marfan, Ehlers Danlos, Cutis Laxa)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9829 |
Ander register | METC VUMC : 2021.0162 |