Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections

Journal of Diabetes Science and Technology
K A PræstmarkJonas Kildegaard

Abstract

After a subcutaneous injection fluid might leak out of the skin, commonly referred to as leakage or backflow. The objective was to examine the influence of needle design and injection technique on leakage after injections in the subcutaneous tissue of humans and pigs. Leakage data were obtained from a post hoc analysis of clinical trial data and from a pig study. Data from the clinical study were used to determine leakage as a function of injection volume, speed and region. Data from the pig study were used to determine leakage as a function of needle wall thickness, needle taper, injection angle, and wait time from end of injection to withdrawal of needle from skin. Leakage volume was positively related to injection volume. Injections in the abdomen caused less leakage than thigh injections. A 32G needle caused less leakage than a 31G and a 32G tip (tapered) needle, and a "straight in" 90° needle insertion angle caused less leakage than an angled (~45°) insertion. Wait times of minimum 3 seconds caused less leakage than immediate withdrawal of the needle after injection. Needle wall thickness and injection speed did not influence leakage. Leakage will be minimized using a thin needle, using 90° needle insertion in the abdomen,...Continue Reading

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Citations

Sep 15, 2016·Expert Opinion on Drug Delivery·Xiaohui Guo, Wei Wang
Oct 11, 2017·Journal of Diabetes Science and Technology·Eric ZijlstraThomas Forst
Jul 26, 2018·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Beate BittnerJohannes Schmidt
Sep 8, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Basel BariLori Berard

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Clinical Trials Mentioned

NCT01680328

Software Mentioned

SAS JMP

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