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Article history: Aim: This study aimed to test the effectiveness of a bundle combining best available evidence to reduce
Accepted 2 December 2016 the incidence of incontinence-associated dermatitis occurrences in critically ill patients.
Methods: The study used a before and after design and was conducted in an adult intensive care unit of an
Keywords: Australian quartenary referral hospital. Data, collected by trained research nurses, included demographic
Critical illness and clinical variables, skin assessment, incontinence-associated dermatitis presence and severity. Data
Incidence
were analysed using descriptive and inferential statistics.
Incontinence-associated dermatitis
Results: Of the 207 patients enrolled, 146 patients were mechanically ventilated and incontinent thus eli-
Intensive care
Intervention
gible for analysis, 80 with 768 days of observation in the after/intervention group and 66 with 733 days
of observation in the before group. Most patients were men, mean age 53 years. Groups were similar
on demographic variables. Incontinence-associated dermatitis incidence was lower in the intervention
group (15%; 12/80) compared to the control group (32%; 21/66) (p = 0.016). Incontinence-associated der-
matitis events developed later in the intensive care unit stay in the intervention group (Logrank = 5.2,
p = < 0.022).
Conclusion: This study demonstrated that the use of a bundle combining best available evidence reduced
the incidence and delayed the development of incontinence-associated dermatitis occurrences in criti-
cally ill patients. Systematic ongoing patient assessments, combined with tailored prevention measures
are central to preventing incontinence-associated dermatitis in this vulnerable patient group.
2016 Elsevier Ltd. All rights reserved.
Early and regular ongoing assessment for IAD assists early detection.
Correct identication of IAD results in correct differentiation of this condition form pressure injuries.
Evidence-based bundled prophylactic interventions are effective in prevention of IAD.
Introduction
Critically ill patients in the intensive care unit (ICU) are a unique,
vulnerable population at high risk of skin damage. The nature of
the critical illness necessitating admission to the ICU often dictates
that patients are mechanically ventilated, managed with sedative
Corresponding author.
and opiate infusions, receive multiple antimicrobial therapy and
E-mail addresses: f.coyer@qut.edu.au (F. Coyer), anne.gardner@acu.edu.au
(A. Gardner), anna.doubrovsky@qut.edu.au (A. Doubrovsky).
are enterally fed. These factors all contribute to faecal incontinence
1
Visiting Professor, Institute for Skin Integrity and Infection Prevention, Univer- and diarrhoea (Jack et al., 2010). Incontinence, specically faecal
sity of Hudderseld, UK. incontinence in critically ill patients, is a signicant and direct
http://dx.doi.org/10.1016/j.iccn.2016.12.001
0964-3397/ 2016 Elsevier Ltd. All rights reserved.
2 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110
causal factor for the development of a hospital-acquired skin injury; incontinence of loose, liquid stools and cognitive impairment were
incontinence-associated dermatitis (IAD) (Beeckman et al., 2015). signicant risk facts for the development of IAD.
Moisture-associate skin damage (MASD) refers to a group of There is a paucity of research addressing IAD in critically ill
clinical conditions characterised by prolonged exposure to vari- patients resulting in signicant gaps in our understanding of its
ous sources of moisture such as urine, faeces, perspiration, wound epidemiology, aetiology, risk factors and management. Some stud-
exudates, mucous and saliva (Gray et al., 2007; Black et al., 2011). ies have examined clinical and economic outcomes associated with
Incontinence-associated dermatitis, a clinical subgroup of MASD, is IAD preventative strategies in the aged care setting (Beeckman
specically caused by prolonged exposure of perineal or perigential et al., 2011a) or acute care setting (Junkin and Selekof, 2007) but
skin contact with urine or faeces. Incontinence-associated der- scant research exists concerning the efcacy of preventative inter-
matitis presents clinically as inammation (erythema) of the skin ventions for IAD in the ICU. The threat of skin integrity loss from IAD
with or without dermal erosion or secondary cutaneous infection. in the critically ill patient is an under-studied and under-reported
Presentation of IAD ranges from mild redness to erosion of large phenomenon.
areas of denuded skin with exudate. Congruently, pain descriptors
reported with IAD range from an itch to a sting or a painful burning
Aim
sensation. Often pain is reported as excruciating and the inconti-
nence episode requires urgent cleaning (Bardsley, 2012; Beeckman
The aim of this study was to test the effectiveness of an inter-
et al., 2015).
ventional patient skin integrity bundle, the Interventional Skin
Incontinence-associated dermatitis is a relatively new term for a
integrity Protocol in a high Risk Environment (InSPiRE). InSPiRE
clinical condition that has been evident for many years. Previously
was a combined intervention for two linked clinical issues; pressure
IAD was referred to as diaper dermatitis or perineal dermatitis,
injuries and IAD, which were analysed and reported separately. This
however these terms do not recognise the aetiology of IAD faecal
paper reports secondary outcomes, reduction of IAD incidence in
and/or urinary incontinence (Junkin and Selekof, 2008). Prolonged
patients in the ICU, as part of a previously reported study (Coyer
skin contact with urine or faeces creates a scenario where exces-
et al., 2015).
sive moisture on the skin overwhelms the stratum corneum skin
structure and presents as over hydration or maceration. Further,
the digestive enzymes found in faeces and urea present in urine, Study hypotheses
when in contact with the skin, serve to create a repetitive cycle of
chemical irritation resulting in inammation and skin breakdown When compared with those patients who received standard skin
(Voegeli, 2016). Clinically IAD is often combined with skin integrity care practices, intensive care patients who received the InSPiRE
damage caused by pressure or shear forces sometimes leading to protocol will:
confusion among clinicians concerning its aetiology or diagnosis
(Beeckman et al., 2015). It can be difcult to distinguish between 1 Have a lower cumulative incidence of IAD
pressure injury and IAD however; if the patient is not incontinent 2 Develop IAD later in their ICU stay
then the condition cannot be IAD. 3 Have IAD scores of less severity
Reported prevalence of IAD varies from 5.6 to 50% (Gray et al., 4 Have IAD processes of care delivered more frequently.
2007; Black et al., 2011; Beeckman et al., 2011a). However, these
data are derived largely from studies conducted in extended care
Methods
facilities. Little is known about IAD prevalence or incidence in the
critically ill patient population. Two conference abstracts reported
Design
IAD prevalence of 3295% across three critical care units (Peterson
et al., 2006) and 35% in one unit (Ehman et al., 2006). In both reports
A before and after design was used where the group of patients
IAD was noted as being of rapid onset and mild to moderate sever-
receiving the InSPiRE protocol (the after or intervention group)
ity.
were compared with a similar group who received standard skin
Further, only two previous studies have examined prevalence
care (the before group).
and time to development of IAD in the critical care setting. Driver
(2007) reported a two phase descriptive study in a 28-bed medical
surgical intensive care unit in Midwestern United States (US) com- Setting and sample
paring two skin care regimes: phase one a no rinse washcloth
and zinc oxide barrier, phase two a no rinse washcloth impreg- The study was conducted over a 12 month timeframe in a 36-bed
nated with 3% dimethicone. The primary study endpoint was skin general adult ICU in an Australian metropolitan quartenary hospital
breakdown dened as red, weepy, denuded skin noted as present. with a large geographical catchment area. The ICU caters for general
Areas of skin denudement were not measured. Further, all patients medical, surgical and trauma patients. As reported by Coyer et al.
had an indwelling urinary catheter in situ. Driver (2007) observed (2015), the ICU is staffed by specialist intensive care medical practi-
that of the 131 patients recruited in phase one, 16 were faecally tioners responsible for admission and management of all patients.
incontinent. Of these, eight (50%) developed IAD. For phase two, Registered nurses (RNs) provide complete care for patients on a 1:1
177 patients were recruited. Of these, 16 were faecally incontinent ratio for mechanically ventilated patients and 1:2 ratio for other
and 3 (19%) developed IAD. Across both study phases 32 of 308 patients. At the time of the study the majority of RNs working in
patients were faecally incontinent and IAD was present in 34% of the ICU (60%) had completed postgraduate critical care qualica-
these patients (11/32). tions. Enrolled or auxiliary nurses do not provide direct patient care
Bliss et al. (2011) examined IAD in 45 critically ill patients in in this ICU.
a surgical trauma ICU to determine time to development, sever- The study sample was all patients admitted to the ICU during
ity and risk factors associated with IAD. These authors found IAD the study period who were greater than 18 years of age, inconti-
occurred in 35% of patients (16/45), with a median time to onset nent, mechanically ventilated and expected to remain in the ICU
of 4 days. Further 81% of patients with IAD (13/16) had IAD on more than 48 hours. For this study, incontinence referred to faecal
discharge from the ICU. The study ndings identied frequent incontinence and was dened as those patients who were mechani-
cally ventilated, sedated and unable to control their bowel function.
F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110 3
Table 1
Intervention (InSPiRE) versus standard skin care.
All patients had an indwelling urinary catheter and were deemed ment and standard clinical use in the ICU as sourced by Queensland
not exposed to urinary incontinence. Health supply contracts.
Excluded patients were those who had: 1) community-acquired Standard skin care practices for the before group were gov-
IAD on admission; 2) Incontinence-associated dermatitis diag- erned by the departmental policies and procedures at the time
nosed within 24 hours of admission; and 3) medical orders of the study. Table 1 presents the intervention, InSPiRE, and stan-
contradicting any part of the InSPiRE protocol. dard skin care processes. Key differences between the intervention,
As this study was part of a previously reported study (Coyer the InSPiRE bundle, and standard care practices were; an earlier
et al., 2015) the sample size was powered on the less rare event, requirement for on admission and ongoing skin assessment and
pressure injury development. Thus, 408 days of observation time or documentation in the intervention, bed-bath using a pre-packaged
102 persons per group with an average ICU stay of four days, was soft cloth and post bed-bath application of a prophylactic bar-
required (Kirkwood and Sterne, 2010). rier lm spray to the perineal buttock area in the intervention,
as opposed to a bed-bath using a basin bowl of water and a pH
Primary outcome balanced cleanser in the standard care measures group.
Excluded Excluded
Fig. 1. Modied CONSORT diagram presenting the ow of patient enrolment into two groups: control and intervention.
Table 2
Demographic characteristics of patients (N = 146).
rater reliability using the percentage agreement of research nurses resources on the InSPiRE bundle (Table 1). Training was provided
observational assessment of IAD was undertaken on a computer by the researcher by means of multi-level strategies to target all
generated random selection of the rst 20% of participants recruited clinical nursing staff. Meetings were conducted with senior clini-
(Hallgren, 2012). The percentage agreement achieved was 95%. Fur- cians, in-service education and one-on-one bedside education was
ther, a random 10% of all data collected was cross checked for provided to all RNs. Registered nurses new to the unit were given
accuracy. For both groups, all patients admitted to the ICU who met training in the intervention as part of the intensive care orienta-
the inclusion criteria were screened and recruited by the research tion program. Further, information resources were provided using
nurses. Patients were assigned a study number. An enrolment log multi-tier approaches for example, brochures summarised evi-
was used to correlate the participants study number with their ini- dence and core features of InSPiRE, a standardised PowerPoint
tials, date of birth and hospital number allowing patients to be presentation with accompanying handouts was used for in-service
identied for any follow up procedures. The enrolment log was education sessions, and staff champions were identied and avail-
destroyed on completion of data collection. Data was collected from able as a resource agents to RNs in the ICU. All hard copy resources
all participants on a daily basis from recruitment to discharge from were available electronically to all RNs for the duration of data
the ICU or death. Fig. 1 displays the ow of patient recruitment and collection in the intervention group timeframe.
enrolment in the study and the number of participants analysed for
the secondary outcome.
Table 3
Clinical characteristics of patients (N = 146).
Table 4
Demographic characteristics of patients with IAD (N = 33).
the development of IAD later in the patients ICU admission. How- of IAD. It is now recommended to use additional skin protectant
ever, the severity of IAD was shown to be worse in those patients products (e.g. acrylate terpolymer barrier lm plus a dimethicone-
who received the InSPiRE bundle. containing product) when IAD is categorised as severe (i.e. the
Faecal incontinence is a common problem in ICU patients and presence of erythema and skin erosion) (Beeckman et al., 2015). The
a signicant causal factor for the development of IAD (Beeckman absence of an additional strategy to treat severe IAD in the InSPiRE
et al., 2015). The incidence range of IAD found in this study (15% bundle may account for an increase in observed IAD severity in the
in the after or intervention group and 32% in the before or con- intervention group.
trol group) highlights the wide variability of this clinical condition. Further to this, participants in this study were only exposed
Similar studies conducted in intensive care environments found to faecal incontinence. Intestinal enzymes present in stool disrupt
IAD incidence with wide ranges from 19 to 95% (Bliss et al., 2011; the integrity of the epidermis and cause skin damage (Black et al.,
Driver, 2007; Ehman et al., 2006; Peterson et al., 2006). However, 2011). The natural course of the IAD condition generally follows
the incidence result from this study (15%), post-intervention, is the the clinical pattern of development, peak, resolution, and healing
lowest yet reported. (Bliss et al., 2011; Ehman et al., 2006). Findings from this study
Findings from this study highlight that participants in the inter- highlight that when a critically ill patient develops IAD, the onset is
vention group developed IAD later in their ICU stay yet, the IAD was rapid and severity is moderate to severe. Given this clinical pattern,
observed in this group was more severe. At the time of this study a a bias existed in this study as patients exited the study (censored
denitive international consensus document to dene, quantify or on discharge from ICU or death) while they still suffered IAD. Thus,
recommend prevention and management strategies for IAD did not the reduced scores at the end of the event were cut from the anal-
exist. A recent expert consensus document (Beeckman et al., 2015) ysis, and the mean scores were higher than expected. The high IAD
now reports a layered approach to prevent and manage IAD using scores in the after (intervention) group may be due to more cen-
a structured skin care regimen; cleanse, protect and restore. This soring of the IAD event in this group. However, this studys data
study used a single layer approach where the daily post bed-bath shows that the resolution of IAD appears to follow the presence
application of a prophylactic barrier lm (acrylate terpolymer) to of, or resolution of, diarrhoea. This would appear to be a natural
the perineum and buttocks delayed the onset of the development conclusion.
8 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110
Fig. 2. Kaplan-Meier Survival analysis Pressure injury (Stage II) formation between control and intervention group.
Table 5
Clinical characteristics of patients with IAD (N = 33).
IAD Score [mean (SD, IQR)] 2.8 (0.98, 2.03.5) 3.7 (0.84, 2.84.4) 2.526** 0.017****
IAD Highest Score [mean (SD, IQR)] 3.4 (1.4, 24) 4.1 (0.9, 3.54.5) 1.424** 0.164
Diarrhoea [number (%)] 21 (100) 12 (100)
Number of days observed 348 175
Mechanical ventilation 75.0%, 73.7% 82.3%, 79.4% 100.5*** 0.345
Proportion of observed days (0.2, 6287%) (0.1, 6890%)
(median, mean, SD, IQR)
Highest daily temperature ( C) (mean, SD, 37.8 (0.5, 37.538.1) 38.1 (0.4, 37.738.4) 1.541** 0.134
IQR))
Lowest daily temperature ( C) (mean, SD, IQR) 36.8 (.5, 36.437.2) 36.7 (.5, 36.637.0) 0.714 **
0.481
Daily serum albumin (g/L) (mean, SD, IQR) 25.1 (4.1, 23.227.6) 24.4 (3.4, 22.827.1) 0.440** 0.663
Steroid administration No 11 No 6 0.017* 0.895
Yes 10 Yes 6
Proportion of observed days for Yes patients 100%, 77.4% 55.3%, 52.3% 12*** 0.056(* )
(median, mean, SD, IQR) (36.6, 37100%) (34.1, 1984%)
Vasoactive drug administration No 9 Yes 12 No 7 Yes 5 0.732* 0.392
Proportion of observed days for Yes patients 32.1%, 36% 47.1%, 41.3% 28*** 0.879
(median, mean, SD, IQR) (22.7, 1559%) (38.8, 674%)
Patient bed-bathed once per 24 h 100%, 87.8% 100%, 100% 66*** 0.024****
Proportion of days observed (20.7, 79100%) (0.0, 80100%)
(median, mean, SD, IQR)
Enteral tube feeding present 87.5%, 83.4% 95.5%, 83.3% 108*** 0.518
Proportion of days observed (median, mean, (21.5, 76100%) (25.2, 65100%)
SD, IQR)
Incontinence-associated dermatitis assessment tools available and discomfort or RNs assessment of patients discomfort. Given
at the time of the study were created for a broad purpose to t that IAD is an uncomfortable and painful condition for patients this
many patient populations and demographics. Although a number of is a recognised study limitation. The potential benet and applica-
assessment tools exist these are mostly used for research purposes bility of this intervention warrants adaptation and testing in other
such as in this study, and are not translated into clinical practice. It is intensive care populations. Testing the bundle, in terms of preven-
suggested this is largely because such tools do not improve clinical tion and treatment outcomes and clinically meaningful outcomes
decision-making or drive patient care (Voegeli, 2016). Interestingly, for patients, in a large multi-centre cluster randomised control trial
the SAT (Kennedy and Lutz, 1996) scores reported in this study were is recommended.
used solely as a standardised measure of severity and were not used
to inform or drive clinical care. Beeckman et al. (2015) recently pro- Conclusion
posed a simplied two level severity categorisation tool to identify
the presence of IAD and its severity; however, this requires testing This is one of the rst studies to test an intervention aimed at
for inter-rater reliability and effectiveness in guiding interventions. preventing and reducing IAD in the intensive care context. This
It is acknowledged that the InSPiRE bundle requires the use study demonstrated that the use of a bundle based on best available
of commercially available products. Bliss et al. (2007) evaluated evidence reduced the incidence and delayed development of IAD
the cost benet of four different skin care protocols in over 900 occurrences in critically ill patients. Results from this study support
nursing home residents. Three of the protocols studied included the use of a bundle of interventions, including prophylactic mea-
applying a skin protectant after each episode of incontinence, and sures, to prevent this hospital-acquired condition in critically ill
one protocol included the application of a polymer lm barrier patients. Ongoing clinical assessment of IAD is imperative to avoid
three times weekly. Although the study found no signicant dif- misdiagnosis and ensure appropriate, targeted treatment regimens
ference in IAD rates between the four skin care protocols, the total are in place.
cost (including product, labour and other incontinence care sup-
plies) per incontinence episode was signicantly lower with the Sources of funding
barrier lm protocol. However, it is recognised that such proto-
cols may be difcult to implement in less wealthy countries where This study was nancially supported by a grant from the Royal
products may not be affordable. Alternative care routines should Brisbane and Womens Hospital Foundation and the School of Nurs-
include prompt cleansing of the skin with water and soft cloth to ing, Queensland University of Technology and product purchase
remove irritants. Further, the skin should be dried with gentle pat- subsidy from SageProductsGlobal, Mayo Healthcare, Australia.
ting motions not rubbing (Beeckman et al., 2015; Litcherfeld et al., SageProductsGlobal had no input into design, conduct or analysis
2015). of this study.
Misclassication of IAD as a stage I or II pressure injury has
signicant repercussions for prevention, treatment and bench-
Contributions
marking of quality of care. Misclassication can result in spurious
reports of stage I and stage II pressure injuries. In this study, to
Study design: FC, AG; Data collection: FC; Data analysis: AD, FC,
avoid misclassication, research nurses were trained in obser-
AG; Manuscript preparation: FC, AG; Manuscript review: FC, AG,
vational assessment and diagnosis of IAD and pressure injuries.
AD.
Although this study reported the percentage of inter-rater agree-
ment between research nurses it is an acknowledged limitation
that no statistical quantication of the degree of agreement of their Conict of interest
assessments was undertaken (Hallgren, 2012). Correct classica-
tion of the two conditions is important as prevention strategies for AG and AD declare they have no conict of interest. FC provides
the two conditions are different. IAD prevention and management educational consultancy for Teleex and 3M.
requires prompt attention to reversible causes of incontinence,
implementation of a structured skin care regimen and timely Acknowledgements
incontinence clean-ups (Beeckman et al., 2015). However, pres-
sure injury prevention strategies focus on the pillars of relief of The authors gratefully acknowledge the work of the registered
pressure, prevention of shear and friction forces and microcli- nurses who assisted with data collection (Robyn Strachan, Rachael
mate management (National Pressure Ulcer Advisory Panel and Dunlop, Simona Asomah-Hartl, Lorraine Walker, Stephanie Deller
European Pressure Ulcer Advisory Panel, 2009; Australian Wound and Lorraine Dyer). We thank the patients who participated in this
Management Association, 2012). Therefore, there is a need to study and the RNs who implemented the protocol.
accurately assess and differentiate IAD from pressure injuries so
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