Burns, scald (T20-35), scar (L90.5), L90.5 T20-T32
Conditions
Interventions
Group 1: Arm/Teil A:
Measurement of the stiffness of the scar and the adjacent healthy skin with the Nimble and the Cutometer at one timpepoint only (Visite 2). This will be repeated three times, by
Sponsors
Universitätskinderspital Zürich
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Part A: •Male and female patients = 1 y , = 18 y •Scars or transplants resulting from burns = 1month , = 10 years, at any location of the body •Signed Informed consent from the patient or the legally authorized representative --------- Part B •Male and female patients = 1 y , = 18 y •Burn wounds < 3 month ago, not requiring surgical wound coverage but healing with scar tissue, at any location of the body OR •Deep partial thickness and/or full thickness burns < 3 month ago, requiring surgical wound coverage, at any location of the body •Signed Informed consent from the patient or the legally authorized representative
Exclusion criteria
Exclusion criteria: Part A and B: Exclusion criteria: •Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissues diseases, e.g. epidermolysis bullosa or congenital metabolic disease directly influencing wound healing) •Inability to follow the procedures of the study, e.g. due to language problems. •Patients with unhealed wounds at or in the proximity of the measurement sites, persisting at the time of measurements with the interventional device or the control device (Cutometer®). •Enrolment of the Investigator, his/her family members, employees and other dependent persons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Evaluation of reliability (test-retest, intra-individually, inter-individually) and validity of the Nimble in comparison to the Cutometer® based on: Skin stiffness k (mbar/mm) at the scar/transplant (= 1month, = 10 years) and according healthy skin at one time point. ------------ Part B: Evaluation of scar maturation over time as an assessment of the accordance of the Nimble, the Cutometer® and the POSAS, based on: Skin stiffness k (mbar/mm) at the scar/transplant and according healthy skin using the Nimble, the Cutometer and the POSAS-questionnaire (Patient and Observer Scar Assessment Scale) over the course of 1 year: 3 month, 6 month, 9 month, 12 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A and B: Safety evaluation, as a comparison between the Cutometer® and the Nimble, based on: •Assessment and reporting of all adverse events (expected and unexpected) will be carried out for the full duration of the study. | — |
Countries
Switzerland
Contacts
Public ContactJulia Elrod
UniversitätsSpital Zürich
Outcome results
None listed