TO EVALUATE THE QUALITY OF LIFE AND PERISTOMAL SKIN OSTOMY PATIENT WITH THE NEW DEVICE SENSURA

In 2006, Coloplast launched in several European countries a new device for ostomy care called Sensura. This clinical research report includes only the results of the subpopulation included in Spain as a part of an international study, involving many countries such as Denmark, United States, Canada, Australia, Poland, Netherlands, France, Slovakia, Germany, UK, Italy, Iceland, Japan, Czech Republic, Portugal, South Korea and Argentina. Objectives and study variables. The main purpose of the study is to evaluate the experience with Sensura, under normal conditions of use, with special attention to skin condition and quality of life. The main objective of the study is to evaluate the quality of life, through Quality of Life Questionnaire called "Stoma QoL". A secondary objective, is to study the correlation between quality of life and the peristomal skin condition. Other Secondary objectives include the evaluation of the patient's current device at the time of entering the study, and by the other hand, the device Sensura and safety evaluation throughout the study. Design study. The study was designed as an open label, non-comparative, multi-national Post Market study. The study period for each patient is 6 to 8 weeks +/-4 days, which includes an initial visit and a final visit. The study population included people who carry a colostomy or ileostomy. Methodology. Regarding Spain, a total of 10 sites participated and included a total of 131 patients. This report only presents results for nine sites and a total of 123 patients. The reason is that the last participating site began the study with a considerable delay. The remaining subjects included in this site together with the other centers in Spain and the other participating countries will be included in the final international report, that will present the overall results. Measurement tools. Stoma-QoL (Quality of Life Questionnaire for people with an ostomy). OST (Ostomy Skin Tool) instrument for the assessment of peristomal skin. Results. As for the quality of life, at baseline we found a mean of 59 out of 100 (SD = 8.8), while the final study visit, mean score was 59.6 out of 100 (SD = 9.3), although the final results on this variable will be presented in the global report, since since it has not reached sufficient population in Spain for the analysis of this variable. The study revealed a significant improvement in the peristomal skin condition at the end of the study, measured by the tool OST (Ostomy Skin Tool). Regarding the evaluation of the SenSura device, there was a significant improvement related to the appearance of leakage of effluent, as well as other items evaluated in relation with the device.