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A comparative clinical study of a new drainable bag for people with ileostomies

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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)

 Mean (±SD)Range
Years since creation of stoma 18 (±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 disease19 (30)
Ulcerative colitis18 (280
Cancer21 (33)
Other6 (9)
Shape of stoma 
Rounded stoma46 (72)
Oval stoma18 (28)
Peristomal skin 
Flat39 (61)
Hernia12 (19)
Cavities8 (13)
Scars8 (13)
Folded

3 (5)

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

 

Number of participants

(n=64)

Manufacturer of appliance normally used 
Dansac22
Coloplast22
Hollister11
ConvaTec6
B.Braun1
Mentor1
Hollister and ConvaTec in combination1
Changing frequency of usual appliance 
More than once a day10
Once a day34
Every 2 ndday15
Every 3 rdday2
Every 4 thday or more rarely2
Did not respond1
Are you satisfied with your usual appliance? 
Very14
Mostly40
Reasonably8
Not completely2
Not at all
64 participants (27 males, 37 females) with a mean (± SD) age of 53±15 years (range: 21-84)
 
ParameterReply

Reference bag

(% of participants)

SenSura bag

(% of participants)

Overall evaluationGood/very good34 *68 *
Overall securityGood/very good32 ?70 ?
ComfortComfortable/very comfortable55 *87 *
DiscretionGood/very good64 ?

79 ?

*significantly different, p<0.0005; ?significantly different, p<0.05, ordinal logistic regression; ?p<0.0001 Table3b. Key performance outcomes for the SenSura and reference outlet

ParameterQuestionReply

Reference 3

% of participants

SenSura 3

% of participants

HygieneWhat is your assessment of the hygiene of the outlet?

Good or

Very good

24 ?68 ?
Security of outletWhat is your assessment of security with regard to the outlet? 2

Good or

Very good

5192
Handling of outletWhat is your general assessment of handling the outlet? 1

Easy or

Very easy

2672
Cleaning of outletWhat is your assessment of cleaning the outlet? 1

Easy or

Very easy

2166
Emptying through outletWhat is your assessment of emptying the bag through the outlet? 1

Easy or

Very easy

30

62

1: 1: Very difficult, 2: Difficult, 3: Easy, 4: Very easy. 2: 1: Very poor, 2: Poor, 3: Reasonable, 4: Good, 5: Very good. 3: significantly different , p<0.0005.

?p<0.0001 Outlet, adhesive and filter performanceSenSura was superior to the control in all outlet performance parameters (security, hygiene, handling, cleaning and emptying), p<0.0005, (Table 3). Additionally, as the SenSura bag could be folded to half its normal size, participants were asked whether they liked that feature; 56% answered ‘a lot’ or ‘very much’. It was not possible to fold the control bag to half its usual size. The participants experienced less adhesive erosion with the SenSura bag than with the control - 77% experienced a little or no erosion with SenSura whereas 55% did with the control bag (p=0.02). Also, the adhesion immediately after application was deemed significantly better with SenSura - 83% experienced good or very good tack with SenSura, compared with 55% for the control (p<0.0001). Flexibility and adhesion during use were not significantly different for the two bags. However, 34% experienced ‘very good’ flexibility and adhesion with the SenSura bag, whereas only 21% did so with the control bag (p>0.3). The sense of security was significantly greater with the SenSura filter compared with the control filter - 80% of participants stated the SenSura filter was ‘good’ or ‘very good’ versus 70% for the control (p<0.05). Some 90% of participants considered the discreetness of the SenSura filter to be ‘good’ or ‘very good’ against 75% for the control filter (p=0.004). The filter stopped functioning during wearing of the bags on 17.5% of all SenSura bags and on 22% of all control bags (p=0.11). For both bags, ballooning (excess air in the bag) was reported as the main reason for dysfunction of the filter. The percentage of participants who woke up at least once at the night due to ballooning while testing the bags was 33% for the SenSura bag and 41% for the control bag (p=0.4). Other significant findings in favour of the SenSura bag were the shape of the bag, the use of a removal tab (or ear), the design of the adhesive and the durability of the soft material. The remaining findings, which showed no significant differences between the bags, concerned leakage through the filter, residues left from the adhesive, and the cutting guide. DiscussionAn ostomy bag that functions well is crucial to individuals with stomas as it makes daily life easier and has a positive impact on their overall quality of life (Prieto, 2005; Nugent, 1999). A high degree of security seems to be the most important issue related to ostomy bags for people with ileostomies: security or reliability of the bag were among the main reasons for being satisfied with their usual ostomy bag in 64% of the cases in the present study. Also, leakage and insufficient sealing of the stoma were the main factors explaining the high frequency (45%) of anxiety about the ileostomy mentioned in a previous study investigating the quality of life of people with stomas (Nugent, 1999). The present study revealed a greater sense of satisfaction with the SenSura bag for all security parameters. The concept of security is an individual one, but from the authors’ experience with stoma care it is reasonable to anticipate that security will cover a wide range of factors related to leakage prevention. The significantly lower degree of adhesive erosion and the better grip of the SenSura adhesive are, most likely, the aspects that contributed to the greater sense of security; these are the parameters most commonly associated with concerns about a filter. The risk of stoma effluent leakage underneath the adhesive is reduced when it adheres well and when there is no adhesive erosion, and the stoma remains sealed as a result. Furthermore, the high sense of security with the SenSura outlet may be related to the fact that it fastens more tightly when folded up than the control outlet. The reasons for the greater sense of security with the SenSura filter are most likely to be found in reduced anxiety with regard to ballooning and filter leakage. The study did not show any differences between the SenSura and the control bag in terms of the frequency of problem-related changes that also involved leakage underneath the adhesive. However, ‘silent leakages’ (when effluent leaks underneath the adhesive without resulting in a change of bags) were not recorded. Recently it has been demonstrated that leakage of stoma effluent underneath the adhesive is related to peristomal skin disorders (Herlufsen et al, 2006b) and future studies should, therefore, record silent leakages. In order to observe peristomal skin changes, the study period should be longer - for example, a month - and participants with peristomal skin disorders should also be included. With the SenSura bag, the participants experienced a more hygienic outlet that was easier to clean, handle and empty. Hygiene is essential due to the frequency with which the drainable bag is emptied. The high level of hygiene for SenSura may be due to the fact that it is sealed like an envelope when the outlet is folded up. This prevents the effluent from being squeezed out onto the outlet exterior while folded, making cleaning easier and improving hygiene. The easier handling and emptying associated with the SenSura outlet ensures that older people with reduced finger mobility can also handle the bag. This may be attributed to the special plastic material used for the closure, which is both stable and soft. Ballooning at night is a problem for people with ileostomies in that it interrupts their sleep. Nevertheless, the problem is difficult to solve, as the liquid stoma effluent blocks the filter when the patient is lying in a horizontal position. In this study, no significant difference in terms of ballooning at night were observed between the bags, and the observed frequency was higher than desired in both. It may be difficult to avoid ballooning at night completely; nevertheless, a solution to this issue is required from future product development programmes. ConclusionThis study revealed that people with an ileostomy can expect a greater sense of security when wearing the SenSura bag than they would from the control bag. This is most likely related to good adhesion and reduced adhesive erosion, as well as better hygiene, and easier handling and emptying of the SenSura bag that was demonstrated in this study. ReferencesAllen, S.(1998) Ileostomy. Professional Nurse; 14: 2,107-112. Black, P.K.(1994) Choosing the correct stoma appliance. British Journal of Nursing; 3: 11, 45-50. Black, P.(2000) Practical stoma care. Nursing Standard; 14: 41, 47-53. Bourgois, M. et al(2001) Satisfaction of ileostomy and colostomy patients with their ostomy collection devices. Journal of WOCN; 21: 3, 16-20. Burch, J.(2004) The Management and care of people with stoma complications. British Journal of Nursing; 13: 6, 307-318. Burch, J.(2005) Exploring the conditions leading to stoma-forming surgery. British Journal of Nursing; 14: 2, 94-98. Collett, K.(2002)Practical aspects of stoma management. Nursing Standard; 17: 8, 45-52. Gray, M.(1998) Ostomy care? Show me the data! Journal of WOCN; 25:1, 2-4. Herlufsen, P. et al(2006a) Study of peristomal skin disorders in patients with permanent stomas. British Journal of Nursing; 15: 16, 854-862. Herlufsen, P. et al(2006b) Ostomy Skin Study: Are Peristomal Skin Disorders Inevitable? Presented at the 16th Biennial Congress of The World Council of Enterostomal Therapists, Hong Kong, 2-6 July. Hollister,United Kingdom(2006) Ostomy Care: One-Piece Systems. www.hollister.com. IMS Consumer Health(2006) New Stoma Patient Audit. London: IMS Health. Lee, J.(2001) Nurse prescribing in practice: patient choice in stoma care. British Journal of Community Nursing; 6: 1, 33-7. Lyon, C.C. et al(2000) The spectrum of skin disorders in abdominal stoma patients. British Journal of Dermatology; 143: 6, 1248-1260. Nugent, K.P., et al(1999) Quality of life in stoma patients. Diseases of the Colon and Rectum; 42: 12, 1569-1574. Prieto, L. et al(2005) Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. Health and Quality of Life Outcomes; 3: 62. Rolstad, B.S., Erwin-Toth, P.L.(2004) Peristomal skin complications: prevention and management. Ostomy Wound Management; 50: 9, 68-77. Rothstein, M.S.(1986) Dermatologic considerations of stoma care. Journal of the Americal Academy of Dermatology; 15: 3, 411-432. Taylor, P.(2005) An introduction to stomas: reasons for their formation. Nursing Times; 101: 29, 63-64. Turnbull, G.B., Erwin-Toth, P.(1999) Ostomy care: foundation for teaching and practice. Ostomy Wound Management; 45: 1A Suppl, S23-30. Wound, Ostomy and Continence Nurses Society(2006) White Paper: Wear Time of a Fecal or Urinary Pouching System. Available: www.wocn.org. Accessed 22 November 2006.

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