title: A comparative study of two-piece ostomy appliances.
abstract: The quality of life of people with a stoma may be affected by peristomal skin disorders and by frequent unplanned changes of ostomy appliances due to problems with those appliances. The aim of this study was to evaluate two new, two-piece ostomy appliances with mechanical couplings (both from the SenSura range by Coloplast) and their ability to address areas that may be important to the quality of life of people with stomas, including appliance changes, stool seepage and overfilling. The study design featured two comparative, crossover, randomized multi-centre studies that were conducted in Germany. The SenSura appliances were evaluated against established reference appliances. Seventy-three individuals with a colostomy (closed-end appliances) and 75 individuals with an ileostomy (drainable appliances) participated in the studies. The participants tested 4-6 flanges of each type within a maximum period of two weeks. The results demonstrated that there was less seepage of stool observed under the SenSura flange when it was removed (p<0.05). Also, there were fewer unplanned changes (p<0.0005) seen with SenSura than with the reference appliances. The SenSura flanges had better adhesion and flexibility and were easier to remove than the references (p<0.0005), and they had greater resistance to erosion (p<0.05). In conclusion, SenSura performed better than the reference appliances on quality of life indicators - there were fewer unplanned changes and less seepage of stool was observed in patients using the SenSura products.
authors.affiliation: CIK-IN, Grossmehring, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Welser
authors.forename: Inge
authors.initials: I
authors.lastname: Riedlinger
authors.forename: Ulla
authors.initials: U
authors.lastname: Prause
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000368:Aged; D001294:Attitude to Health; D003125:Colostomy / Q000009:adverse effects / Q000295:instrumentation* / Q000523:psychology; D018592:Cross-Over Studies; D004322:Drainage / Q000009:adverse effects / Q000295:instrumentation* / Q000523:psychology; D004867:Equipment Design; D004868:Equipment Failure; D005076:Exanthema / Q000209:etiology; D005260:Female; D005858:Germany; D006801:Humans; D007081:Ileostomy / Q000009:adverse effects / Q000295:instrumentation* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D015404:Nursing Methodology Research; D011788:Quality of Life / Q000523:psychology; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires