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Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants

Not Applicable
Conditions
A
Registration Number
JPRN-UMIN000017591
Lead Sponsor
Japan Vaccine Co.,Ltd
Brief Summary

The thickness of the epidermis was 1.44 - 1.54 mm (95% CI), and the lengths from the skin surface to the muscle fascia and bone were 11.52 - 12.28 mm (95% CI), and 25.66 - 26.93 mm (95% CI), respectively, at the anterolateral thigh. At the center of the deltoid muscle, skin thickness was similar to that at the thigh, furthermore the lengths from the skin surface to the muscle fascia and bone were 8.49 - 9.10 mm (95% CI), and 17.38 - 18.31 mm (95% CI), respectively. The lengths from the skin surface to the muscle fascia and bone were 1 - 2 mm shorter in 2-month-old infants than those in older generations. Therefore, the appropriate needle length for intramuscular injections in Japanese infants was 16 mm (5/8 inch) at any age and sites, and with 25 mm (1 inch) needles at a 90-degree angle being associated with the risk of over-penetration.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
180
Inclusion Criteria

Not provided

Exclusion Criteria

(1) infant who has an abnormality in the measurement target site. (2) infant with who investigator judges stable and circumference measurements and image inspection is difficult. (3) infant who is suffering from severe acute and chronic disease. (4) infant who has an experience of any damage in the arms or legs. (5) infant who has or experienced all of neurological or muscle disease. (6) Other, infant who investigator judges ineligible as a subject. (7) infant whose written consent form is not obtained by his/her representative's own free will.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
A
Secondary Outcome Measures
NameTimeMethod
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