Echographic Measurement of Skin Thickness in Children

Novosanis NV259 enrolled

Overview

To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of children (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI. Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer

Study Type

OBSERVATIONAL

Enrollment

259

Conditions

Skin Thickness

Interventions

Echographic measurement of skin thicknessOTHER

(Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® \& VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.

Eligibility

Sex: ALLMin age: 8 WeeksMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children * Age: 8 weeks to 18 years * Dutch-speaking * Caucasian Exclusion Criteria: * Using ointment, crème, gels or oral medication based on corticoids * Suffering from skin diseases (psoriasis, burning wounds) * Pregnancy or lactating

Locations (3)

University of Antwerp

Wilrijk, Antwerp, Belgium

Child & Family (Dutch: Kind&Gezin) Antwerp

Antwerp, Belgium

primary and secundary schools in Antwerp, Belgium

Antwerp, Belgium

Outcomes

Primary Outcomes

skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)

Time frame: 5-10 minutes

skin thickness (in millimeters) of the proximal ventral forearm (both left and right)

Time frame: 5-10 minutes

skin thickness (in millimeters) of the deltoid region (both left and right)

Time frame: 5-10 minutes

skin thickness (in millimeters) of the medial thigh region (both left and right)

Time frame: 5 minutes

Data from ClinicalTrials.gov

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