A prospective randomized comparative study to evaluate the safety and efficacy of topical quick penetrating solution (QPS) of Heparin (1000 IU/ml) versus Heparin gel (200 IU/ml) in prevention of intravenous cannula related thrombophlebitis in post operative onco surgical intensive care unit (ICU) patients

Abstract

Intravenous cannulation usage is a vital component for the patient admitted at hospitals and is known to cause thrombophlebitis in upto 70% of patients so this study is needed to evaluate profile of topical quick penetrating solution of Heparin and compare it with Heparin gel in prevention of thrombophlebitis in post operative onco-surgery patients admitted in intensive care unit (ICU) in terms of safety and effectiveness. To evaluate the safety and efficacy of topical quick penetrating solution of Heparin and compare it with Heparin gel in prevention of thrombophlebitis in post operative onco-surgery patients admitted in intensive care unit (ICU). A prospective, randomized, parallel group, comparative, single centre, clinical study. A total 100 patients undergoing intravenous cannulation that has been planned to remain in situ for at least 72 hours indoor period were enrolled. Patients were randomized in Group A (Heparin Topical solution) vs Group B (Heparin gel). Investigational product was applied on skin around dressing covering intravenous cannulation site approximately every 8 hours for the treatment period of 72 hours. Patients were evaluated for incidences of infusion phlebitis, first signs of phlebitis and treatment emergent application site reactions and were statistically analysed for statistical significance, p - value below 0.05 levels was considered to be significant. Incidences of infusion phlebitis Grade 2 was found to be higher in “heparin gel group” than in “Topical Heparin Group” (17 vs 7 patients, p=0.0192). Incidences of first sign of phlebitis grade 1 was found to be higher in “heparin gel group” than in “Topical Heparin Group” (24 vs 10 patients, p=0.003123). Mean time to develop Grade I and Grade II phlebitis was comparable and no adverse effects were reported in either group. Heparin QPS was more effective in the prevention of infusion-associated phlebitis with similar safety profile as heparin gel.