Randomized Controlled Pilot Study on the Effects of a Release Silver Medication in Patients Cannulated with Button Hole Technique: Experimental Protocol

Abstract

Introduction: Several observational studies showed that the button hole technique is easy to apply, fast, with a reduction in the formation of hematomas, scars and pain perception. Anyway, other studies showed that the button hole technique has been associated to an increase of the risk of infection, with high rates of infection incidence in arterio venous fistula (AVF) site and septicemia, compared to a rope ladder technique. Objective: The aim of this study is to test the use of a dressing with release of silver ions, for the reduction of the infection incidence rate and the pain symptomatology in patients on hemodialysis with AVF cannulation by button hole technique. Materials and Methods: A prospective, regional, multicenter, randomized pilot study, with balanced allocation 1: 1, with parallel-groups, controlled with standard care group. Results: A solid experimental protocol which can be used as a model for RCT pilot studies which have the objective to study the impact of a dressing for the reduction of the infection incidence rate and pain symptomatology. Conclusions: This pilot study can produce results and trends for the structuring of a subsequent national and multicenter RCT. This model can be used in other similar clinical settings for an evidence-based research approach. (nursing)