Kezia Ann Præstmark1, Bente Stallknecht2, Morten Lind Jensen3, Thomas Sparre3, Nils Berg Madsen4, Jonas Kildegaard5. 1. Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark Novo Nordisk A/S, Device R&D, Hillerød, Denmark kezj@novonordisk.com. 2. Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark. 3. Novo Nordisk A/S, Medical & Science Devices, Søborg, Denmark. 4. Novo Nordisk A/S, Device R&D, Hillerød, Denmark. 5. Novo Nordisk A/S, Insulin Pharmacology, Måløv, Denmark.
Abstract
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the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.
RCT Entities:
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.
Authors: Laurence J Hirsch; Michael A Gibney; John Albanese; Shankang Qu; Kenneth Kassler-Taub; Leslie J Klaff; Timothy S Bailey Journal: Curr Med Res Opin Date: 2010-06 Impact factor: 2.580