Functionality and Performance of Device
Conditions
Brief summary
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
Detailed description
Up to 400 children, ages 2 months through 14 years 1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. 2. To document completeness of injections; completeness is defined as \<10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters. 3. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Infants and children between ages 2 months and 14 years * Outpatient, expected to go home day of surgery * Written consent and assent when appropriate * Willing to complete and return pain diary (postcard) after 48 hours
Exclusion criteria
* Presently have skin rash at the intended injection site * Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids). * Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy. * Skin disorders that may predispose them to develop skin lesions at sites of trauma. * Present use of any blood thinning medications. * In the 10-11 year old cohort, none of the participants can have started puberty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of injection | within one minute after injection | To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. Measurement of the bleb size following injection will recorded in millimeters. |
| Size of bleb on skin after injection | within 2 minutes after injection | Measurement of the bleb size immediately following injection will be determined using a millimeter ruler |
| Acceptability by subject | up to 48 hrs | subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia. |
Countries
United States
Outcome results
None listed