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

TY - JOUR

T1 - Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections

AU - Præstmark, Kezia Ann

AU - Stallknecht, Bente

AU - Jensen, Morten Lind

AU - Sparre, Thomas

AU - Madsen, Nils Berg

AU - Kildegaard, Jonas

N1 - © 2016 Diabetes Technology Society.

PY - 2016/7/1

Y1 - 2016/7/1

N2 - BACKGROUND: 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.METHOD: 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.RESULTS: 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.CONCLUSIONS: Leakage will be minimized using a thin needle, using 90° needle insertion in the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.

AB - BACKGROUND: 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.METHOD: 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.RESULTS: 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.CONCLUSIONS: Leakage will be minimized using a thin needle, using 90° needle insertion in the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.

U2 - 10.1177/1932296815626723

DO - 10.1177/1932296815626723

M3 - Journal article

C2 - 26798083

SN - 1932-2968

VL - 10

SP - 914

EP - 922

JO - Journal of Diabetes Science and Technology

JF - Journal of Diabetes Science and Technology

IS - 4

ER -