title: Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections.
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the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.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.affiliation: Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark Novo Nordisk A/S, Device R&D, Hillerød, Denmark kezj@novonordisk.com.
authors.forename: Kezia Ann
authors.initials: KA
authors.lastname: Præstmark
authors.affiliation: Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Bente
authors.initials: B
authors.lastname: Stallknecht
authors.affiliation: Novo Nordisk A/S, Medical & Science Devices, Søborg, Denmark.
authors.forename: Morten Lind
authors.initials: ML
authors.lastname: Jensen
authors.affiliation: Novo Nordisk A/S, Medical & Science Devices, Søborg, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sparre
authors.affiliation: Novo Nordisk A/S, Device R&D, Hillerød, Denmark.
authors.forename: Nils Berg
authors.initials: NB
authors.lastname: Madsen
authors.affiliation: Novo Nordisk A/S, Insulin Pharmacology, Måløv, Denmark.
authors.forename: Jonas
authors.initials: J
authors.lastname: Kildegaard
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous / Q000295:instrumentation* / Q000379:methods*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009339:Needles; D012867:Skin; D013552:Swine
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: backflow; injection technique; insulin injections; leakage; pen needle