title: The inflammatory potential of surgical glove lubricants: Biosorb, Keoflo, calcium carbonate and Hydrocote after intravitreal injection.
abstract: Surgical glove powders have been implicated in serious postoperative foreign body reactions due to contamination of the operative field. Inflammatory responses to glove lubricants or mold release agents have to date been studied to a lesser extent in ocular tissues than other body tissues, although powder contamination of intraocular lenses, with severe postoperative anterior chamber inflammatory responses, have been reported. The object of this study was to grade and quantitate the inflammatory response of surgical glove lubricants, namely Biosorb, Keoflo, calcium carbonate and Hydrocote (a hydrogel polymer film used in powderless gloves), as introduced into the posterior chamber on New Zealand white rabbits. In a double masked GLP study, a total of 150 eyes were evaluated. For each of the four test samples, a dose response curve was obtained at 10 micrograms (Keoflo only), 125 micrograms, 250 micrograms, 500 micrograms, 1000 micrograms, and 1500 micrograms. Study parameters were the quantitation of inflammatory cells in the aqueous and vitreous, and ocular irritation and inflammation, as graded by the rabbit inflammation score system, at 0 and 48 hours post-injection. A Wilcoxen signed-rank test used to evaluate statistical significance (p < 0.05). A test vitreal cell count was less that 50 cells/mm3 and the overall mean clinical response was less than 2.0. This study established that Keoflo at all concentrations 10 micrograms-1000 micrograms), and Biosorb at concentrations greater than 1000 micrograms were inflammatory. Calcium carbonate and Hydrocote were non-inflammatory at concentration of 125 micrograms-1500 micrograms. The unoperated, sham, vehicle and Ocugel controls were all non-inflammatory. The positive Zymozan A controls were defined as inflammatory. In conclusion, no glove powder is totally safe, even small amounts of glove powder (10 micrograms) can elicit an inflammatory immune response. If all glove powder averages 700mg/pair, this should be removed prior to contact with a patients tissue. Powder-free gloves and greatly reduce the potential inflammatory risk associated with powdered gloves.
authors.affiliation: Department of Ophthalmology, Kangnam St. Mary's Hospital, Catholic University of Korea, Medical College, Seoul, Korea.
authors.forename: H S
authors.initials: HS
authors.lastname: Park
authors.forename: M S
authors.initials: MS
authors.lastname: Kim
mesh_terms: D000818:Animals; D001082:Aqueous Humor / Q000187:drug effects*; D002119:Calcium Carbonate / Q000009:adverse effects*; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D005128:Eye Diseases / Q000139:chemically induced / Q000473:pathology; D005500:Follow-Up Studies; D005549:Foreign-Body Reaction / Q000139:chemically induced* / Q000473:pathology; D005932:Gloves, Surgical; D007267:Injections; D008153:Lubrication; D011817:Rabbits; D013213:Starch / Q000009:adverse effects* / Q000031:analogs & derivatives; D014822:Vitreous Body / Q000187:drug effects* / Q000473:pathology
chemical_list: D013213:Starch; D002119:Calcium Carbonate