[Clinical evaluation of a new device for patients with colostomies].

INTRODUCTION

There are some 32,000 people in Spain who have undergone an osteotomy; of these, approximately 76% have a colostomy. While a patient undergoes rehabilitation, it is essential that the collecting device provide the patient security, cutaneous protection, effectiveness against odors and discretion; all of which can greatly help a patient to accept his/her new body image, to recover his/her self-esteem and to reincorporate into his/her normal life. In order to attend to the ever more demanding demands placed by this body of patients, a new closed one piece bag named "Alterna Ideal" has been developed. The purpose of this clinical test is to show the efficiency of this product under real treatment conditions.

MATERIALS AND METHODS

This prospective, open multi-centric and non-comparative study permitted both patients and nursing professional to evaluate Alterna Ideal under habitual use conditions. Each patient tested 19 bags and made two check-ups with health professionals, one at the beginning of this study and the other at the end of it. Besides the demographic data, the evaluating parameters referred to the four elements which make up this device: an adhesive component, a filter, a soft cover and its shape. At the same time, the product as a whole was evaluated along with its duration, a patient's preference for it over the previously used product and the condition of the skin in the colon area at the beginning and the end of this test. To analyze data, descriptive statistics were used.

RESULTS

This study included 187 patients, 54.5% were male and 45.5% female; average age was 61.9 years. The average stoma diameter was 33.7 mm; the average time since a patient underwent his/her colostomy was 25.2 months; 82.4% had surpassed one month since their osteotomy. 79.1% of these patients did not show any complication related to their osteotomy. The average length of use of these bags was 13.37 hours. Statistically significant differences were obtained regarding the condition of the skin in the colon area since this condition improved as this study progressed. These are the percentages of patients who rated each of these concepts as either good or very good: immediate application, 91.5%; feeling of security, 85.6%; flexibility and adaptability, 90.9%; effectiveness against leakage, 85.5%; removal, 91.5%; the filter's functioning, 88.2%; the shape of the bag, 92%; the quality of the soft covering, 94.7%; and overall rating, 92.5%. 75.9% of these patients who had previously used another product stated they preferred Alterna Ideal. These are the percentages of professionals who rated each of these concepts as either good or very good: the setting, 95.7%; cutaneous protection, 94.7%; the filter's functioning, 93%; the shape of the bag, 95.7%; the quality of the soft covering, 98.4%; and overall rating, 97.3%. 96.8% of the professionals involved in this study stated they would recommend this product in the future.

COMMENTS

The results of this study confirm the effectiveness of Alterna Ideal as a collecting device for persons who have undergone a colostomy. This product is a highly valuable therapeutic alternative which can aid this group of patients to enjoy an improved quality of life.