VOL: 103, ISSUE: 9, PAGE NO: 32-33
Katrin Schmitz, SCN, RN, is health economist, Gesundheitszentrum Lang, Dinslaken
Katrin Schmitz, SCN, RN, is health economist, Gesundheitszentrum Lang, Dinslaken; Carola Seidenstricker, SCN, RN, Almed GmbH, Zwickau; Andrea Arnhold, SCN, RN, Nomamed Schutze/Schuster GbR, Harsum-Asel; Verner Droste Antje Tillig, SCN, RN, Keimed GmbH, Dresden; Verner Droste, SCN, RN, Publicare GmbH, Cologne; Gertrud Brink, SCN, RN, Sanitaus Beuthel, Wuppertal; Elke Fronhoffs-Schommen, SCN, RN, Sanitaus Kelz, Munchengladbach; Alexandra Koch-Adolph, SCN, RN, Rodamed GmbH, Saarlouis; Doris M SCN, RN, Nobaymed GmbH, Ottensoos; Ebba Tautz, SCN, RN, Medicare GmbH, Neubrandenburg; Kerstin Winkelmann, SCN, RN, VisڊVital Service, GmbH, Magdeburg, Germany are all stoma care nurses.
Abstract Schmitz, K. et al (2007) A comparative clinical study of a new drainable bag for people with ileostomies. www.nursingtimes.net.
Abstract Schmitz, K. et al (2007) A comparative clinical study of a new drainable bag for people with ileostomies. www.nursingtimes.net.This study aimed to compare the performance of a new one-piece drainable ostomy bag (SenSura) with that of a well-established bag to identify whether problems related to the use of ostomy bags improved. Sixty-four German people with an ileostomy tested each bag for a week in a randomised, open, comparative crossover study. SenSura was preferred by 79% of the participants and was superior to the control bag with regard to the key performance parameters. Individuals with an ileostomy preferred the SenSura. The benefits may relate to good tack (adhesion when the bag is first applied) and reduced adhesive erosion, as well as better hygiene and easier handling/emptying. Over the last six years around 47,000 new ileostomies have been created in the UK, 60,000 in Germany and 530,000 in the US (IMS Consumer Health, 2006). An ileostomy is a surgically created opening of the ileum (small intestine) on the abdominal skin surface, allowing the elimination of stoma effluent (output from a stoma) (WOCN, 2006; Allen, 1998). It is created when there is a need to remove the colon, usually to treat colon carcinoma and inflammatory bowel diseases such as Chrohn’s disease or ulcerative colitis (Burch, 2005; Taylor, 2005). The effluent is usually collected in a drainable ostomy bag and disposed of through an outlet as needed. Problems associated with stoma bagsThe following problems in connection with the use of a stoma bag have been identified as being related to quality of life (Prieto et al, 2005):
- Skin disorders in the peristomal area;
- Interruption of sleep;
- Anxiety about a full bag;
- Noises from the bag;
- Indiscreetness of the bag;
- Worries about bag-leakage, smell and odour.
Although the standard of ostomy bags has improved dramatically since the production of the world’s first disposable ostomy bag in 1957, further improvements are needed to minimise bag-related complications and improve the quality of life of people with stomas (Nugent et al, 1999). Leakage from the stoma bagStoma effluent leakage underneath the ostomy bag adhesive appears to be the main problem related to the use of ostomy bags for people with ileostomies (Bourgois et al, 2001; Nugent et al, 1999). It also explains the high incidence of peristomal skin disorders among people with ileostomies (Herlufsen et al, 2006a; Herlufsen et al, 2006b; Lyon et al, 2000). In a Danish epidemiological study 57% of those with ileostomies were diagnosed with a peristomal skin disorder (mild, moderate or severe) and the main reasons were faeces-induced erosion and maceration of the skin (Herlufsen et al, 2006a). Leakage of stoma effluent mainly occurs due to the liquid consistency and high amount of effluent from an ileostomy, as the colon has been removed and water re-absorption that occurs in the colon is impaired (Allen, 1998). The typical amount of output has been estimated to be around 500-800ml per day, but it can be higher (Burch, 2004; Black, 2000; Allen, 1998). The effluent contains pancreatic juices, enzymes and bile salts that can be very corrosive, both to the peristomal skin and to the ostomy bag (Burch 2004; Rothstein, 1986). When the ostomy bag adhesive erodes, stoma effluent leaks onto the peristomal skin. This results in eroded skin with subsequent reduced adhesion of the ostomy bag. A vicious cycle of bag leakage, skin erosion, bag leakage occurs (Rolstad and Erwin-Toth, 2004). The adhesive on the ostomy bag should adhere effectively to the skin and, at the same time, be highly resistant to erosion (decomposition) to prevent leakage and protect the peristomal skin. The outletOptimal hygiene of the outlet is important as the bag is emptied several times a day. The outlet must be easy to clean and handle when it is emptied, and it must be leakproof. The changing frequency of one-piece drainable bags varies from country to country, however recommended wear time is anything between one and four days in the UK (Collett, 2002; Lee, 2001; Black, 1994), and in the US the minimum acceptable wear time has been specified as three days (WOCN, 2006). The bag should be emptied when half full - which is equivalent to approximately 5-7 times a day (Collett, 2002) - and the outlet must be resistant to wear and tear. BallooningBallooning (excess air in the bag) can also be problematic. In a Belgian study investigating the quality of life among 141 people with an ileostomy, 90% experienced ballooning (Nugent et al, 1999). Ballooning induces anxiety about bag leakage and reduces the discreetness of the bag. During sleep, due to the horizontal position of the patient and the bag, the liquid effluent from an ileostomy can block the air filter on the bag; this results in air being trapped in the bag, so ballooning occurs and the bag has to be changed. The problem can be minimised by using a long-life filter. Literature reviewTo our knowledge,this is the first comparative study investigating the performance of one-piece drainable ostomy bags. There is a lack of evidence within the area of stoma care and there have been numerous requests in the literature for more research involving the subject of pouch selection (Nugent et al, 1999; Turnbull and Erwin-Toth, 1999; Gray, 1998). AimThe aim of the study was to compare the performance of a new one-piece drainable ostomy bag, SenSura, with a well-established bag, focusing on minimising problems related to the use of ostomy bags. The primary aim was to find out if preference was for the control bag or the SenSura bag;secondary aims were to ascertain parameters relating to the adhesive, outlet, filter and the bag in general. MethodsProductsThe test and control bags were one-piece drainable ostomy bags with a hydrocolloid skin adhesive welded on to a pouch and provided with a filter. The test bag was the SenSura bag with a double-layer adhesive and a ‘Hideaway’ outlet (Coloplast A/S, Humleb櫬 Denmark), introduced in Europe in 2006. The outlet is equipped with a closure made of plastic material to ease handling and cleaning, and it can be folded up and hidden away. The bag can be folded up to half size to make it more discreet. The SenSura bag attempts to solve the ‘classic adhesive dilemma’ - that the most important adhesive parameters of erosion resistance, good adhesion, tack (good adhesion when the bag is first applied), flexibility and easy removal - cannot be optimised at the same time. The SenSurauses two layers of adhesive: a dark lower layer with a high-absorption capacity, and an upper erosion-resistant layer that delays erosion by encapsulating the lower layer. The control bag was the Moderma Flex with Lock n Roll outlet and a single-layer adhesive (Hollister Inc, IL), introduced in Europe in 2002. The adhesive on this bag has hollow spaces, also called ‘air space technology’, designed to vary the position of skin in contact with the adhesive with every application (Hollister, 2006). This allows the peristomal skin to rest and recover with each application without compromising adhesion. ParticipantsThis investigation involved 27 men and 37 women. Their mean age was 53 years (range: 21-84 years). They normally used a one-piece open ostomy bag and were able to apply, remove and empty the bags themselves. None used a convex system (a bowl-shaped adhesive that pushes the stoma forward). None of the participants were pregnant or breast-feeding, or had been treated with chemotherapy or radiotherapy during the study or in the two months prior to the study. They were not suffering from skin complications (bleeding or broken skin) around the stoma at the time of inclusion. Baseline stoma data are outlined in Tables 1a and 1b; baseline appliance data is listed in Table 2. The baseline data presented in Tables 1a, 1b and 2, together with problem-related changes, pain when removing the bag and skin evaluations are based on all 64 participants; the remaining parameters are based on the 53 participants remaining after some had dropped out or had been excluded. Determination of the sample size was based on an expected preference for the test product of at least 70%. The sample size was estimated at 62 participants, for which a significance level of 0.05 and a power of 0.9 were used. Table 1a. Baseline stoma dataTable 1b. Baseline stoma data (n=64)
|Years since creation of stoma 1||8 (±7)||0.25-32|
|Maximum stoma diameter (mm)||30 (±7)||15-50|
|Height of stoma (mm)||16 (±11)||1-40|
|1.Minimum time since creation of ileostomy: 3 months|
|Number of participants (%)|
|Main reasons for creation of ileostomy|
|Chron’s disease||19 (30)|
|Ulcerative colitis||18 (280|
|Shape of stoma|
|Rounded stoma||46 (72)|
|Oval stoma||18 (28)|
Study designThe investigation was an open, randomised, comparative, crossover multi-centre study conducted in Germany. Each participant tested the SenSura bag for one week and the control bag for one week in randomised order (Fig 1). The bags were changed in line with the participant’s normal changing frequency. Table 2. Baseline data on appliances normally usedEthicsThe Freiburger Ethical Committee in Germany approved the study. The study was conducted in accordance with the Declaration of Helsinki II 1964 (last amended in Tokyo 2004) and in accordance with both Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (commonly known as the Medical Devices Directive) and the international ISO standard ISO/DIS 14155-1:2000 - Clinical Investigation of Medical Devices for Human Subjects. StatisticsAll statistical analyses were performed using SAS statistical software, version 9.1 (SAS Institute Inc, Cary, NC). The following methods were used in the data analyses: ordinal logistic regression (proportional odds), logistic regression, analysis of variance, McNemar test, binomial test and paired t-test. ResultsThe bag as a wholeOf 56 participants reponsing to the question ‘Which of the two bags do you prefer?’ 79% preferred the SenSura bag to the control bag. This result was consistent with a subgroup analysis of those participants who did not routinely use a Coloplast product (Dansac, Hollister, Convatec, B.Braun and Mentor). SenSura had a median rating of four or five - equivalent to ‘good’ or ‘very good’ - in all parameters measured, whereas the control bag in eight cases was evaluated with a median rating of two or three, equating to ‘poor’ or ‘reasonable’. Key performance outcomes for the SenSura and control bags are shown in Tables 3a and 3b. These were evaluated on a scale of 1-5 (1 = very poor, 2 = poor, 3 = reasonable, 4 = good, 5 = very good). There were no differences between the bags with regard to the number of problem-related changes (p=0.8). The mean wear time was 24 hours for both bags. In total, 40% of participants wanted to use the SenSura bag in the future instead of their own bag, whereas 11% wanted to use the control bag. Evaluations of the peristomal skin after use of the two bags were not significantly different (p>0.7). Table 3a. Key performance outcomes for the SenSura and reference bag. Outcomes are evaluated on a scale of 1-5