Intensive and Critical Care Nursing 40 (2017) 110

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Intensive and Critical Care Nursing

journal homepage: www.elsevier.com/iccn

An interventional skin care protocol (InSPiRE) to reduce

incontinence-associated dermatitis in critically ill patients in the
intensive care unit: A before and after study
Fiona Coyer a,,1 , Anne Gardner b , Anna Doubrovsky c
a
Joint Apointment with the School of Nursing, Queensland University of Technology and Intensive Care Services, Royal Brisbane and Womens Hospital,
Victoria Park Rd., Kelvin Grove, Queensland, 4059, Australia
b
School of Nursing, Midwifery and Paramedicine (Signadou Campus), Australian Catholic University, PO Box 256, Dickson ACT, 2602, Australia
c
School of Nursing, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, Queensland, 4059 Australia

a r t i c l e i n f o a b s t r a c t

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.

Implications for clinical practice

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-associated dermatitis (IAD) (Beeckman et al., 2015).
Moisture-associate skin damage (MASD) refers to a group of
clinical conditions characterised by prolonged exposure to vari-
ous sources of moisture such as urine, faeces, perspiration, wound
exudates, mucous and saliva (Gray et al., 2007; Black et al., 2011).
Incontinence-associated dermatitis, a clinical subgroup of MASD, is
specically caused by prolonged exposure of perineal or perigential
skin contact with urine or faeces. Incontinence-associated der-
matitis presents clinically as inammation (erythema) of the skin
with or without dermal erosion or secondary cutaneous infection.
Presentation of IAD ranges from mild redness to erosion of large
areas of denuded skin with exudate. Congruently, pain descriptors
reported with IAD range from an itch to a sting or a painful burning
sensation. Often pain is reported as excruciating and the inconti-
nence episode requires urgent cleaning (Bardsley, 2012; Beeckman
et al., 2015).
Incontinence-associated dermatitis is a relatively new term for a
clinical condition that has been evident for many years. Previously
IAD was referred to as diaper dermatitis or perineal dermatitis,
however these terms do not recognise the aetiology of IAD faecal
and/or urinary incontinence (Junkin and Selekof, 2008). Prolonged
skin contact with urine or faeces creates a scenario where exces-
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,
when in contact with the skin, serve to create a repetitive cycle of
chemical irritation resulting in inammation and skin breakdown
(Voegeli, 2016). Clinically IAD is often combined with skin integrity
damage caused by pressure or shear forces sometimes leading to
confusion among clinicians concerning its aetiology or diagnosis
(Beeckman et al., 2015). It can be difcult to distinguish between
pressure injury and IAD however; if the patient is not incontinent
then the condition cannot be IAD.
Reported prevalence of IAD varies from 5.6 to 50% (Gray et al.,
2007; Black et al., 2011; Beeckman et al., 2011a). However, these
data are derived largely from studies conducted in extended care
facilities. Little is known about IAD prevalence or incidence in the
critically ill patient population. Two conference abstracts reported
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
IAD was noted as being of rapid onset and mild to moderate sever-
ity.
Further, only two previous studies have examined prevalence
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-
paring two skin care regimes: phase one a no rinse washcloth
and zinc oxide barrier, phase two a no rinse washcloth impreg-
nated with 3% dimethicone. The primary study endpoint was skin
breakdown dened as red, weepy, denuded skin noted as present.
Areas of skin denudement were not measured. Further, all patients
had an indwelling urinary catheter in situ. Driver (2007) observed
that of the 131 patients recruited in phase one, 16 were faecally
incontinent. Of these, eight (50%) developed IAD. For phase two,
177 patients were recruited. Of these, 16 were faecally incontinent
and 3 (19%) developed IAD. Across both study phases 32 of 308
patients were faecally incontinent and IAD was present in 34% of
these patients (11/32).
Bliss et al. (2011) examined IAD in 45 critically ill patients in
a surgical trauma ICU to determine time to development, sever-
ity and risk factors associated with IAD. These authors found IAD
occurred in 35% of patients (16/45), with a median time to onset
of 4 days. Further 81% of patients with IAD (13/16) had IAD on
discharge from the ICU. The study ndings identied frequent
incontinence of loose, liquid stools and cognitive impairment were
signicant risk facts for the development of IAD.
There is a paucity of research addressing IAD in critically ill
patients resulting in signicant gaps in our understanding of its
epidemiology, aetiology, risk factors and management. Some stud-
ies have examined clinical and economic outcomes associated with
IAD preventative strategies in the aged care setting (Beeckman
et al., 2011a) or acute care setting (Junkin and Selekof, 2007) but
scant research exists concerning the efcacy of preventative inter-
ventions for IAD in the ICU. The threat of skin integrity loss from IAD
in the critically ill patient is an under-studied and under-reported
phenomenon.
Aim
The aim of this study was to test the effectiveness of an inter-
ventional patient skin integrity bundle, the Interventional Skin
integrity Protocol in a high Risk Environment (InSPiRE). InSPiRE
was a combined intervention for two linked clinical issues; pressure
injuries and IAD, which were analysed and reported separately. This
paper reports secondary outcomes, reduction of IAD incidence in
patients in the ICU, as part of a previously reported study (Coyer
et al., 2015).
Study hypotheses
When compared with those patients who received standard skin
care practices, intensive care patients who received the InSPiRE
protocol will:
1 Have a lower cumulative incidence of IAD
2 Develop IAD later in their ICU stay
3 Have IAD scores of less severity
4 Have IAD processes of care delivered more frequently.
Methods
Design
A before and after design was used where the group of patients
receiving the InSPiRE protocol (the after or intervention group)
were compared with a similar group who received standard skin
care (the before group).
Setting and sample
The study was conducted over a 12 month timeframe in a 36-bed
general adult ICU in an Australian metropolitan quartenary hospital
with a large geographical catchment area. The ICU caters for general
medical, surgical and trauma patients. As reported by Coyer et al.
(2015), the ICU is staffed by specialist intensive care medical practi-
tioners responsible for admission and management of all patients.
Registered nurses (RNs) provide complete care for patients on a 1:1
ratio for mechanically ventilated patients and 1:2 ratio for other
patients. At the time of the study the majority of RNs working in
the ICU (60%) had completed postgraduate critical care qualica-
tions. Enrolled or auxiliary nurses do not provide direct patient care
in this ICU.
The study sample was all patients admitted to the ICU during
the study period who were greater than 18 years of age, inconti-
nent, mechanically ventilated and expected to remain in the ICU
more than 48 hours. For this study, incontinence referred to faecal
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
Table 1
Intervention (InSPiRE) versus standard skin care.
Intervention group: InSPiRE bundle
A. Assessment of skin integrity
Skin assessment on admission.
Within four hours of admission to the ICU a full skin
integrity physical examination is performed.
Findings are documented.
Ongoing assessment.
Skin integrity physical examination is performed and
documented every 12 h.
Full documentation in electronic clinical information
system comprises drop down menu of descriptors of
skin colour, moisture, texture, oedema and turgor.
Loss of skin integrity is recorded noting the location,
size, description of erosion and the amount and type of
exudate.
The ICU RN team leader is notied of presence of IAD.
Digital images are taken of the skin integrity loss and
attached to the patients record in the electronic
clinical information system.
B. Strategies to prevent IAD
Skin hygiene.
Patients bed bathed once per day, unless otherwise
clinically indicated, using a pH balanced cleansing
agent (pre-packaged washcloth with 2% chlorhexidine
and 1% dimethicone).
Barrier lm spray (acrylate terpolymer) applied to the
perineal area following daily bed bath.
Dry aky skin treated with application of a topical
moisturiser.
Incontinence cleansing with water and soft cloth. Skin
dried by gentle patting.
Maintenance of stable skin temperature
Skin contact with plastic surfaces is avoided.
All patients had an indwelling urinary catheter and were deemed
not exposed to urinary incontinence.
Excluded patients were those who had: 1) community-acquired
IAD on admission; 2) Incontinence-associated dermatitis diag-
nosed within 24 hours of admission; and 3) medical orders
contradicting any part of the InSPiRE protocol.
As this study was part of a previously reported study (Coyer
et al., 2015) the sample size was powered on the less rare event,
pressure injury development. Thus, 408 days of observation time or
102 persons per group with an average ICU stay of four days, was
required (Kirkwood and Sterne, 2010).
Primary outcome
The primary outcome was the development of IAD.
Incontinence-associated dermatitis was dened as skin dam-
age caused by contact with urine and/or faeces (Gray et al., 2007;
Black et al., 2011).
Intervention
The intervention, InSPiRE, provides a bundle of IAD preven-
tion measures based on best available evidence (Vollman, 2007;
Beeckman et al., 2009, 2010, 2011b; Robinson et al., 2011). The
InSPiRE bundle targets key areas of nursing clinical assessment and
documentation, hygiene measures and IAD prevention strategies
for critically ill patients in the ICU. Specically, patients were bed
bathed daily using a pre-packaged wash cloth impregnated with
2% chlorhexidine gluconate. An alcohol-free barrier spay was then
applied to the patients buttocks and perineum to provide a breath-
able, transparent protective coating (acrylate terpolymer) to the
skin. The decision to use the latter product was independent of the
manufacturers and was founded on evidenced-based clinical judg-
3
Before group: standard skin care
A. Assessment of skin integrity
Skin assessment on admission.
Within 24 h of admission to the ICU a patient skin
assessment is performed.
Findings are documented.
Ongoing assessment.
Skin assessment is performed and documented in
electronic clinical information system every 24 h.
Skin assessment is recorded as intact or not intact.
B. Strategies to prevent IAD
Skin hygiene
Patients bed bathed once or twice per day using a
basin bowl of water and pH balanced soap-free
cleanser or surgical sponges containing chlorhexidine.
Frequency of bed bath and cleansing agent used was at
the RNs discretion.
There is no policy for preventative measures for IAD.
There is no policy for application of a topical
moisturiser.
Incontinence cleansing with a basin bowl of water and
pH balanced soap-free cleanser.
Maintenance of stable skin temperature
Skin contact with plastic surfaces is avoided.
ment and standard clinical use in the ICU as sourced by Queensland
Health supply contracts.
Standard skin care practices for the before group were gov-
erned by the departmental policies and procedures at the time
of the study. Table 1 presents the intervention, InSPiRE, and stan-
dard skin care processes. Key differences between the intervention,
the InSPiRE bundle, and standard care practices were; an earlier
requirement for on admission and ongoing skin assessment and
documentation in the intervention, bed-bath using a pre-packaged
soft cloth and post bed-bath application of a prophylactic bar-
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
balanced cleanser in the standard care measures group.
Measures
A study specic data collection form was developed by
the researchers. This included demographic information, clinical
variables, a skin assessment tool (Talley and OConnor, 2007),
established IAD severity scoring tool (Kennedy and Lutz, 1996),
Sequential Organ Failure Assessment (SOFA) score (Moreno et al.,
1999; Ferreira et al., 2001) and IAD process of care measures.
Demographic and clinical variables
Demographic variables were gender, age, diagnosis on admis-
sion, body mass index (BMI), comorbidities, mode of admission to
the ICU, length of ICU stay and discharge to ward or death. Clinical
variables were number of mechanical ventilation days, presence
of indwelling urinary catheter (yes/no), presence of enteral tube
feeding (yes/no), type of faecal incontinence (diarrhoea yes/no),
vasopressor and steroid medications.
4 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110

Control group Intervenon group

April to August 2010 October 2010 to March 2011

Assessed for eligibility Assessed for eligibility

(n=904) (n=1052)

Excluded Excluded

Not meeng criteria Not meeng criteria (admied

(admied <24hours n=389, <24 hours n=440, admission
admission diagnosis of burns diagnosis burns n=29)
n=15)
Refused to paricpate (n=42)
Refused to paricpate (n=31)
Other reason (n=436)
Other reason (n=367)

Control group (n=102) Intervenon group (n=105)

Recieved standard skin Recieved InSPiRE protocol
care pracces

Analysed for primary outcome Analysed for primary outcome

(n=102) (n=105)
Analysed for secondary outcome Analysed for secondary outcome
(n=66) (n=80)
Excluded from analyses (n=0) Excluded from analyses (n=0

Fig. 1. Modied CONSORT diagram presenting the ow of patient enrolment into two groups: control and intervention.

Skin assessment tool Sequential organ failure assessment (SOFA)

A skin assessment tool based on physical examination (Talley
and OConnor, 2007) and assessment of IAD (Gray et al., 2007; Black
et al., 2011) was used to standardise clinical assessment between
the research nurses.
Incontinence-associated dermatitis severity
The Skin Assessment Tool (SAT) (Kennedy and Lutz, 1996) was
designed to classify skin injury caused by IAD. The SAT has a cumu-
lative severity score based on the size of the affected area, the
degree of redness and the depth of erosion. The total SAT score
ranges from 0 (no IAD) to 10 (severe IAD). The tool contains three
domains: area of skin breakdown (score 03); skin redness (score
03); and erosion (score 04). The SAT is suitable for the critically
ill patient population as it does not require patient self-report. Fur-
ther, the SAT does not depend on descriptors that were originally
intended to describe pressure injuries; it is easy to use and provides
clinicians with an estimated area of skin breakdown. Reliability of
the SAT is reported in a recent randomised control trial comparing
the effectiveness of perineal washcloths with 3% dimethicone to
a soap and water cleaning regime (Cohen Kappa K = 0.84, CI 95%)
(Beeckman et al., 2011a).
Presence of faecal incontinence was recorded. Location of IAD
was recorded using a body gure diagram. For those patients who
developed IAD two digital images of the IAD lesion (close-up and
midway using a disposable centimetre measuring tape with the
patient de-identied) were taken by a medical photographer using
a digital camera.
Sequential organ failure assessment is a scoring system used to
determine the extent of a patients organ function or failure in ICU
(Moreno et al., 1999). The score is an assessment of clinical indices
for six body systems: respiratory, cardiovascular, hepatic, coagu-
lation, renal and neurological. Sequential organ failure assessment
score ranges from 0 to 24 where each organ/system is graded from
normal (0 score) to the most abnormal (score of 4). The mean and
highest SOFA scores have been shown to be useful predictors of
mortality and organ function during ICU stay. While the Acute
Physiology and Chronic Health Evaluation II score has better dis-
criminative power to determine mortality during the rst 24 hours
of ICU admission, SOFA provides a mechanism to score patients
severity of illness on a daily basis during ICU stay (Ferreira et al.,
2001).
Process of care measures
Incontinence-associated dermatitis process of care measures
were dened as part of the InSPiRE bundle and standard skin
care (Table 1) and were measured to quantify treatment delity.
They included: assessment and documentation of skin integrity on
admission and ongoing for the patients ICU stay; skin hygiene and
perineal skin care measures; nutritional assessment by the depart-
ments dietitian and commencement of enteral feeding.
Procedure
Following ethical approval, research nurses employed for data
collection received face to face training in IAD clinical assess-
ment from skin integrity clinical nurse specialists and face to face
training on the data collection tools from the researcher. Inter-
 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110 5

Table 2
Demographic characteristics of patients (N = 146).

Variable Before (n = 66) After (n = 80) Test Signicance (p)

Male [number (%)] 42 (63.6) 50 (62.5) 0.020* 0.887

Age (years) [mean (SD, IQR)] 52.7 53.3 0.211** 0.833
(18.2, 36.865.3) (16.1, 41.368.0)
BMI [median, mean (SD, IQR)] 25.9, 27.5 27.5, 28.2 2180*** 0.127
(5.7, 23.729.0) (6.2, 23.931.2)
(Missing = 2)
Admission via 35 (53.0) 38 (47.5) 0.442* 0.506
emergency department
Yes [number (%)]
Comorbitities [number (%)]
Hypertension 10 (15.2) 27 (33.8)
Non-insulin dependent diabetes 11 (16.7) 1 (1.3)
Smoking 1 (1.5) 10 (12.5)
Insulin dependent diabetes 1 (1.0) 0.0
Peripheral vascular disease 0.0 0.0
Other 8 (12.1) 26 (32.5)
Nil 35 (53.0) 16 (20.0)
Diagnosis
[number (%)]
Missing = 2
Neurological trauma/bleed 19 (28.8) 21 (26.9)
Neurological disorders (tumour, seizures, meningitis, stroke, 6 (9.1) 7 (9.0)
Guillan Barre syndrome)
Respiratory failure (pneumonia, COPD, pulmonary embolus, 13 (19.7) 17 (21.8)
pulmonary oedema)
Trauma 10 (15.2) 8 (10.3)
Sepsis 6 (9.1) 9 (11.5)
Cardiovascular disorders (cardiac arrest) 2 (3.0) 4 (5.1)
Renal and metabolic disorders (failure, drug overdose/toxicity) 2 (3.0) 4 (5.1)
Abdominal disorders (haemorrhage, pancreatitis, abdominal 8 (12.1) 8 (10.3)
aortic aneurysm)
ICU Length of stay (days) [median, mean (SD, IQR)] 10.5, 13.2 7, 9.4 2419*** 0.384
(10.5, 716) (6.9, 516)
Daily SOFA Score [median, mean (SD, IQR)] 4, 4.3 3, 3.9 2353.5*** 0.402
Missing = 2 (3.1, 26) (2.8, 26)
*
Discharged to ward 57 73 0.885 0.347
Death 9 7

IQR Interquartile range.

****signicance at p < 0.05.
*
Pearson Chi-Square test.
**
t-test.
***
Mann-Whitney U test.

rater reliability using the percentage agreement of research nurses
observational assessment of IAD was undertaken on a computer
generated random selection of the rst 20% of participants recruited
(Hallgren, 2012). The percentage agreement achieved was 95%. Fur-
ther, a random 10% of all data collected was cross checked for
accuracy. For both groups, all patients admitted to the ICU who met
the inclusion criteria were screened and recruited by the research
nurses. Patients were assigned a study number. An enrolment log
was used to correlate the participants study number with their ini-
tials, date of birth and hospital number allowing patients to be
identied for any follow up procedures. The enrolment log was
destroyed on completion of data collection. Data was collected from
all participants on a daily basis from recruitment to discharge from
the ICU or death. Fig. 1 displays the ow of patient recruitment and
enrolment in the study and the number of participants analysed for
the secondary outcome.
resources on the InSPiRE bundle (Table 1). Training was provided
by the researcher by means of multi-level strategies to target all
clinical nursing staff. Meetings were conducted with senior clini-
cians, in-service education and one-on-one bedside education was
provided to all RNs. Registered nurses new to the unit were given
training in the intervention as part of the intensive care orienta-
tion program. Further, information resources were provided using
multi-tier approaches for example, brochures summarised evi-
dence and core features of InSPiRE, a standardised PowerPoint
presentation with accompanying handouts was used for in-service
education sessions, and staff champions were identied and avail-
able as a resource agents to RNs in the ICU. All hard copy resources
were available electronically to all RNs for the duration of data
collection in the intervention group timeframe.

After (intervention) group

Before group
From April to August 2010 patients were recruited to receive
standard skin care measures (Table 1).
Intervention implementation
During September 2010, following completion of data collection
in the before group, all ICU RNs received training and information
Following completion of the intervention training period, the
intervention was implemented. From October 2010 to March 2011,
all patients recruited to the after group received the InSPiRE bun-
dle (Table 1). Registered nurse adherence to the intervention was
achieved by the presence and actions of InSPiRE clinical champi-
ons, ongoing education about InSPiRE and regular cyclic feedback
to RNs on the ICUs IAD incidence data.
6 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110

Table 3
Clinical characteristics of patients (N = 146).

IAD [number (%)] 21 (31.8) 12 (15.0) 5.847* 0.016****

Diarrhoea [number (%)] 20 (30.3) 12 (15.0) 4.949* 0.026****
Diarrhoea [number (%)] 22 (33.3) 13 (16.3) 5.791* 0.016****
(Assuming all IAD
patients had diarrhoea)
Number of days observed 733 768
Mechanical ventilation 75.0%, 73.7% 76.4%, 71.7% 2553*** 0.732
Proportion of observed (20.7, 5689%) (22.7, 5589%)
days
(median, mean, SD,
IQR)
Highest daily temperature ( C) (mean, SD, 37.9 37.9 0.408** 0.684
IQR)) (0.6, 37.438.3) (0.6, 37.638.3)
Lowest daily temperature ( C) (mean, SD, IQR) 36.7 36.8 0.513** 0.609
(0.6, 36.337.2) (0.5, 36.437.0)
Daily serum albumin (g/L) (mean, SD, IQR) 26.1 25.4 0.969** 0.334
(4.9, 23.129.1) (4.3, 22.627.8)
*
Steroid administration No 36 No 53 2.082 0.149
Proportion of observed days for Yes patients Yes 30 Yes 27
(median, mean, SD, IQR) 90.5%, 66.7% 75.0%, 60.8% 347.5*** 0.350
(36.6, 26100%) (34.1, 29100%)
Vasoactive drug administration No 33 No 51 2.798* 0.094
Proportion of observed days for Yes patients Yes 33 Yes 29
***
(median, mean, SD, IQR) 33.3%, 40.0% 50.0%, 48.3% 410.5 0.337
(26.4, 1950%) (30.8, 2073%)
Patient bed-bathed once per 24 h 100%, 93.0% 100%, 99.8% 1872*** <0.001****
Proportion of days observed (15.1, 94100%) (1.9, 100100%)
(median, mean, SD, IQR)
Enteral tube feeding present No 11 No 15 0.107* 0.743
Proportion of observed days for Yes patients Yes 55 Yes 65
***
(median, mean, SD, IQR) 90.0%, 85.5% 100%, 83.9% 1758 0.871
(20.0, 80100%) (23.3, 77100%)

Ethical considerations provides an overview of the patient and process characteristics of

This study was approved by the relevant hospital and univer-
sity human Research Ethics Committees. Patients, or their surrogate
decision-makers, were approached to participate in the study, were
provided with written study information and signed a consent form
agreeing to participate.
Analysis
Data were entered into the Statistical Package for the Social
Sciences (SPSS) (Version 18.0. Chicago, IL, US). A random 10% of
all data were crossed checked for accuracy. Data were analysed
rst to describe all patients. Descriptive statistics were calculated
for all variables (means and standard deviations for continuous
variables; frequencies and percentages for categorical variables).
Incontinence-associated dermatitis cumulative incidence was cal-
culated by dividing the total number of new cases of IAD, multiplied
by 100, by the total number of included participants in the time
period. KaplanMeier survival analysis with logrank (Mantel-Cox)
test was used to compare time to new IAD events analyses between
the two groups (Altman, 1991). Chi-square test of independence, t-
tests or Mann Whitney U tests were used to determine differences
in IAD scores and process of care practices delivered between the
two groups. The level of signicance selected for all analyses was
alpha < 0.05.
Results
Sample
Of the sample of 146 participants, 66 with 733 days of observa-
tion were in the control group and 80, with 768 days of observation,
were in the intervention group. The majority of the sample in both
intervention and control groups were men. Groups were similar in
terms of admitting diagnoses, comorbidities and BMI. Tables 2 and 3
the two groups. Tables 4 and 5 present clinical and demographic
characteristics of patients with IAD.
Hypothesis 1. Of the 80 patients in the intervention group, 12
developed IAD compared with 21 out of 66 in the before group.
The cumulative incidence of IAD was 15% in the intervention group
(12/80) compared to 32% in the before group (21/66) (X2 = 5.847,
df = 1, p = 0.016), a signicant reduction of 17%.
Hypothesis 2. The intervention, InSPiRE, lowered the number of
IAD events which developed over time (Logrank [Mantel-Cox] = 5.2,
df = 1, p = 0.022) (Fig. 2). Further, IAD developed later in the ICU stay
of those patients in the intervention group (9.4 days) compared to
patients in the before group (7.4 days).
Hypothesis 3. The IAD score was signicantly worse in the inter-
vention group (t-test = 2.526, p = 0.017). The highest IAD score is
also worse in the intervention group but not signicantly (Table 1).
Hypothesis 4. Both groups had 98% of skin assessments and
documentation completed (intervention group within 4 hours and
the before group within 24 hours) and ongoing skin assessments
and documentation completed (intervention group every 12 hours;
before group every 24 hours). There was no difference in the fre-
quency of bed-baths or the application of a topical moisturiser
between the two groups. Treatment practices for IAD (how often
the acrylate terpolymer based prophylactic treatment was applied)
differed between groups as this was only practiced in the interven-
tion group where this was applied following 94% of bed-bathing
episodes.
Discussion
This study is one of the rst to test an intervention to prevent
and reduce incidence of IAD in the critically ill patient. Findings
from this study show that the implementation of the InSPiRE bun-
dle resulted in a signicant reduction in the incidence of IAD and
 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110 7

Table 4
Demographic characteristics of patients with IAD (N = 33).

Variable Before (n = 21) After (n = 12) Test Signicance (p)

Male [number (%)] 8 (38.1) 5 (41.7) 0.041* 0.840

Age (years) [mean (SD, IQR)] 50.43 54.08 0.650** 0.521
(16.48, (13.68,
37.061.5) 41.563.5)
BMI [median, mean (SD, IQR)] 26.6, 26.4 30.0, 28.4 105*** 0.734
(5.1, 22.929.1) (7.9, 22.131.6)
(Missing = 2)
Admission via 9 (42.9) 7 (58.3) 0.481* 0.392
emergency department
Yes [number (%)]
Comorbitities [number (%)]
Hypertension 5 (23.8) 3 (25.0)
Non-insulin dependent diabetes 4 (19.0) 0 (0.0)
Smoking 0 (0.0) 2 (16.7)
Insulin dependent diabetes 1 (4.8) 0 (0.0)
Peripheral vascular disease 0 (0.0) 0 (0.0)
Other 2 (9.5) 3 (25.0)
Nil 9 (42.9) 4 (33.3)
Diagnosis [number (%)]
Neurological trauma/bleed 3 (14.3) 3 (25.0)
Neurological disorders (tumour, seizures, 2 (9.5) 1 (8.3)
meningitis, stroke, Guillan Barre syndrome)
Respiratory failure (pneumonia, COPD, PE, 7 (33.3) 3 (25.0)
pulmonary oedema)
Trauma 2 (9.5) 0 (0.0)
Sepsis 4 (19.0) 2 (16.7)
Cardiovascular disorders (cardiac arrest) 0 (0.0) 0 (0.0)
Renal and metabolic disorders (failure, drug 1 (4.8) 2 (16.7)
overdose/toxicity)
Abdominal disorders (trauma, haemorrhage, 2 (9.5) 1 (8.3)
pancreatitis, abdominal aortic aneurysm)
ICU Length of stay (days) [median, mean (SD, 14, 19.3 14, 15.5 125.5*** 0.985
IQR)] (14.0, 9.529) (5.5, 11.520.5)
Daily SOFA Score [median, mean (SD, IQR)] 4, 5.4 4.5, 5.2 118.5*** 0.954
Missing = 1 (4.0, 37) (3.1, 38)
*
Discharged to ward 19 10 0.366 0.545
Death 2 2
IAD Score [mean (SD, IQR)] 2.8 3.7 2.526 **
0.017****
(0.98, 2.03.5) (0.84, 2.84.4)

IQR Interquartile range.

*
Pearson Chi-Square test.
**
t-test.
***
Mann-Whitney U test.
****
signicance at p < 0.05.

the development of IAD later in the patients ICU admission. How-
ever, the severity of IAD was shown to be worse in those patients
who received the InSPiRE bundle.
Faecal incontinence is a common problem in ICU patients and
a signicant causal factor for the development of IAD (Beeckman
et al., 2015). The incidence range of IAD found in this study (15%
in the after or intervention group and 32% in the before or con-
trol group) highlights the wide variability of this clinical condition.
Similar studies conducted in intensive care environments found
IAD incidence with wide ranges from 19 to 95% (Bliss et al., 2011;
Driver, 2007; Ehman et al., 2006; Peterson et al., 2006). However,
the incidence result from this study (15%), post-intervention, is the
lowest yet reported.
Findings from this study highlight that participants in the inter-
vention group developed IAD later in their ICU stay yet, the IAD was
observed in this group was more severe. At the time of this study a
denitive international consensus document to dene, quantify or
recommend prevention and management strategies for IAD did not
exist. A recent expert consensus document (Beeckman et al., 2015)
now reports a layered approach to prevent and manage IAD using
a structured skin care regimen; cleanse, protect and restore. This
study used a single layer approach where the daily post bed-bath
application of a prophylactic barrier lm (acrylate terpolymer) to
the perineum and buttocks delayed the onset of the development
of IAD. It is now recommended to use additional skin protectant
products (e.g. acrylate terpolymer barrier lm plus a dimethicone-
containing product) when IAD is categorised as severe (i.e. the
presence of erythema and skin erosion) (Beeckman et al., 2015). The
absence of an additional strategy to treat severe IAD in the InSPiRE
bundle may account for an increase in observed IAD severity in the
intervention group.
Further to this, participants in this study were only exposed
to faecal incontinence. Intestinal enzymes present in stool disrupt
the integrity of the epidermis and cause skin damage (Black et al.,
2011). The natural course of the IAD condition generally follows
the clinical pattern of development, peak, resolution, and healing
(Bliss et al., 2011; Ehman et al., 2006). Findings from this study
highlight that when a critically ill patient develops IAD, the onset is
rapid and severity is moderate to severe. Given this clinical pattern,
a bias existed in this study as patients exited the study (censored
on discharge from ICU or death) while they still suffered IAD. Thus,
the reduced scores at the end of the event were cut from the anal-
ysis, and the mean scores were higher than expected. The high IAD
scores in the after (intervention) group may be due to more cen-
soring of the IAD event in this group. However, this studys data
shows that the resolution of IAD appears to follow the presence
of, or resolution of, diarrhoea. This would appear to be a natural
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)

IQR Interquartile range.

*
Pearson Chi-Square test.
**
t-test.
***
Mann-Whitney U test.
****
signicance at p < 0.05.
 F. Coyer et al. / Intensive and Critical Care Nursing 40 (2017) 110
Incontinence-associated dermatitis assessment tools available
at the time of the study were created for a broad purpose to t
many patient populations and demographics. Although a number of
assessment tools exist these are mostly used for research purposes
such as in this study, and are not translated into clinical practice. It is
suggested this is largely because such tools do not improve clinical
decision-making or drive patient care (Voegeli, 2016). Interestingly,
the SAT (Kennedy and Lutz, 1996) scores reported in this study were
used solely as a standardised measure of severity and were not used
to inform or drive clinical care. Beeckman et al. (2015) recently pro-
posed a simplied two level severity categorisation tool to identify
the presence of IAD and its severity; however, this requires testing
for inter-rater reliability and effectiveness in guiding interventions.
It is acknowledged that the InSPiRE bundle requires the use
of commercially available products. Bliss et al. (2007) evaluated
the cost benet of four different skin care protocols in over 900
nursing home residents. Three of the protocols studied included
applying a skin protectant after each episode of incontinence, and
one protocol included the application of a polymer lm barrier
three times weekly. Although the study found no signicant dif-
ference in IAD rates between the four skin care protocols, the total
cost (including product, labour and other incontinence care sup-
plies) per incontinence episode was signicantly lower with the
barrier lm protocol. However, it is recognised that such proto-
cols may be difcult to implement in less wealthy countries where
products may not be affordable. Alternative care routines should
include prompt cleansing of the skin with water and soft cloth to
remove irritants. Further, the skin should be dried with gentle pat-
ting motions not rubbing (Beeckman et al., 2015; Litcherfeld et al.,
2015).
Misclassication of IAD as a stage I or II pressure injury has
signicant repercussions for prevention, treatment and bench-
marking of quality of care. Misclassication can result in spurious
reports of stage I and stage II pressure injuries. In this study, to
avoid misclassication, research nurses were trained in obser-
vational assessment and diagnosis of IAD and pressure injuries.
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
assessments was undertaken (Hallgren, 2012). Correct classica-
tion of the two conditions is important as prevention strategies for
the two conditions are different. IAD prevention and management
requires prompt attention to reversible causes of incontinence,
implementation of a structured skin care regimen and timely
incontinence clean-ups (Beeckman et al., 2015). However, pres-
sure injury prevention strategies focus on the pillars of relief of
pressure, prevention of shear and friction forces and microcli-
mate management (National Pressure Ulcer Advisory Panel and
European Pressure Ulcer Advisory Panel, 2009; Australian Wound
Management Association, 2012). Therefore, there is a need to
accurately assess and differentiate IAD from pressure injuries so
appropriate prevention and/or treatment strategies are put in
place.
Replication is needed to conrm this studys ndings, prefer-
ably in other contexts. The InSPiRE bundle, developed specically
for critically ill patients, is context specic to the ICU where it was
implemented. Further, this study used a before and after design; a
recognised weaker quasi-experimental design where confounders
(other factors that could have affected the study outcomes) were
not controlled for (Gordis, 2014). Although a randomised controlled
trial to assess the intervention would have been appropriate, this
study used a before and after design to implement a change in
practice with the introduction of the InSPiRE bundle in the after
group. The lack of quantication of diarrhoea is an acknowledged
study limitation. Further, this study did not collect data on clini-
cally meaningful outcomes of IAD such as patients reports of pain
9
and discomfort or RNs assessment of patients discomfort. Given
that IAD is an uncomfortable and painful condition for patients this
is a recognised study limitation. The potential benet and applica-
bility of this intervention warrants adaptation and testing in other
intensive care populations. Testing the bundle, in terms of preven-
tion and treatment outcomes and clinically meaningful outcomes
for patients, in a large multi-centre cluster randomised control trial
is recommended.
Conclusion
This is one of the rst studies to test an intervention aimed at
preventing and reducing IAD in the intensive care context. This
study demonstrated that the use of a bundle based on best available
evidence reduced the incidence and delayed development of IAD
occurrences in critically ill patients. Results from this study support
the use of a bundle of interventions, including prophylactic mea-
sures, to prevent this hospital-acquired condition in critically ill
patients. Ongoing clinical assessment of IAD is imperative to avoid
misdiagnosis and ensure appropriate, targeted treatment regimens
are in place.
Sources of funding
This study was nancially supported by a grant from the Royal
Brisbane and Womens Hospital Foundation and the School of Nurs-
ing, Queensland University of Technology and product purchase
subsidy from SageProductsGlobal, Mayo Healthcare, Australia.
SageProductsGlobal had no input into design, conduct or analysis
of this study.
Contributions
Study design: FC, AG; Data collection: FC; Data analysis: AD, FC,
AG; Manuscript preparation: FC, AG; Manuscript review: FC, AG,
AD.
Conict of interest
AG and AD declare they have no conict of interest. FC provides
educational consultancy for Teleex and 3M.
Acknowledgements
The authors gratefully acknowledge the work of the registered
nurses who assisted with data collection (Robyn Strachan, Rachael
Dunlop, Simona Asomah-Hartl, Lorraine Walker, Stephanie Deller
and Lorraine Dyer). We thank the patients who participated in this
study and the RNs who implemented the protocol.
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