Interventional study to evaluate the safety, reliability and validity of the medical device Nimble in comparison to established devices for objective assessment of scar maturation (Cutometer®) and subjective assessment (POSAS) in children after partial deep dermal or full thickness burns

Not Applicable

• Conditions: Burns, scald (T20-35), scar (L90.5),; Scar conditions and fibrosis of skin; Burns and corrosions; L90.5; T20-T32

• Registration Number: DRKS00014031
• Lead Sponsor: niversitätskinderspital Zürich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-12
• Study Completion: 2019-08-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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

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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

Part A and B:

•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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: Evaluation of reliability (test-retest, intra-individually, inter-individually) and validity of the Nimble in comparison to the Cutometer® based on:<br><br>Skin stiffness k (mbar/mm) at the scar/transplant (= 1month, = 10 years) and according healthy skin at one time point.<br><br>------------<br><br>Part B: Evaluation of scar maturation over time as an assessment of the accordance of the Nimble, the Cutometer® and the POSAS, based on:<br><br>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. <br>

Secondary Outcome Measures

Name	Time	Method
Part A and B:<br><br>Safety evaluation, as a comparison between the Cutometer® and the Nimble, based on:<br>•Assessment and reporting of all adverse events (expected and unexpected) will be carried out for the full duration of the study.<br>