DRKS00014031Completed未知
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 enrollmentStarted: February 12, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 1 Years to 18 Years (—)
- Sex
- All
Inclusion Criteria
- •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
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.
Investigators
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