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 - Nimble – novel objective assessment of scar maturation

niversitätskinderspital Zürich0 sites40 target enrollmentFebruary 12, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 12, 2018

End Date

August 23, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversitätskinderspital Zürich

•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
•\-\-\-\-\-\-\-\-\-
•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
•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

•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.