A Prospective, Multicenter Study to Compare a Disposable, High-fluid Capacity Underpad to Nonpermeable, Disposable, Reusable Containment Products on Incontinence-associated Dermatitis Rates Among Skilled Nursing Facility Residents
Due to the high prevalence of incontinence among skilled nursing facility (SNF) residents, incontinence-associated dermatitis (IAD) is a common occurrence. In addition, facility staff may mistakenly identify IAD as a pressure injury. A prospective, descriptive, multicenter study was conducted in 3 Connecticut facilities to evaluate the effect of substituting a disposable, high-fluid capacity underpad for nonpermeable disposable and reusable containment products on the rate of IADs.
Residents with and without IAD but with high IAD risk scores who were bed- or chairbound or ambulatory and used disposable nonpermeable briefs and underpads or reusable, laundered containment products when in bed longer than 2 hours were randomly enrolled and observed for a 4-week period. Facility staff were trained on the importance of differentiating between IAD and pressure injury; they substituted the study product (a disposable, high-fluid capacity underpad) for all previously used containment products. Patient risk for IAD and skin condition were assessed using the Perineal Assessment Tool (PAT) and the Skin Condition Assessment Tool (SAT), respectively, at 5 time points: baseline, week 1, week 2, week 3, and week 4. The PAT is a 4-item instrument based conceptually on the 4 determinants in perineal skin breakdown; subscales are rated from 1 (least risk) to 3 (most risk), with a total score range of 4 to 12. The SAT is used to evaluate IAD specifically, generating a cumulative severity score ranging from 0 to 3 on area of skin affected, degree of redness, and depth of erosion. Final data analysis was conducted on 40 residents: 25 had IAD present at enrollment and 15 were deemed high risk for developing IAD. Mean SAT scores in the 25 participants with IAD decreased with significance at week 1 (P = .0016), week 2 (P = .0023), week 3 (P = .0005), and week 4 (P <.0001). Baseline IAD severity scores averaged 3.3 ± 1.7. Overall IAD average severity scores in this group decreased from baseline mean of 3.3 ± 1.7 to 0.7 ± 1.4 at week 4 (P <.001). The 15 participants with intact, nondamaged skin at enrollment did not develop IAD from baseline to week 4, and PAT score risk levels decreased from high (7 or greater) to low (6 or less) as a result of a specific reduction in the duration of irritant exposure category for 11 (73%) of this group of participants by week 4. PAT risk level scores for both IAD and non-IAD participants at baseline averaged 8.1 ± 1.4; after 4 weeks, they averaged 7.0 ± 1.5). Although change was not significant, results suggest the use of a disposable, high-fluid capacity underpad improved SAT scores over time. IAD rates increased in each facility, but pressure injury incidence rates decreased for the study duration. Replacing a nonpermeable, reusable containment product with a disposable, high-fluid capacity underpad when SNF residents are in bed longer than 2 hours may impact the severity of IAD and reduce its incidence. The inverse impact reported on IAD and pressure injury incidence rates 1 month after training suggest study educational efforts had a short-lasting effect. Future research is indicated to determine the most effective method to improve nurses’ ability to identify and distinguish IAD from pressure injury in the SNF setting.
According to a systematic review,1 prevalence rates of urinary incontinence among nursing home residents range from 43% to 77% (median 58%); for women, the rate ranges from 60% to 78% and for men from 45% to 72%.2 An economical analysis3 showed the time from nursing facility admission to occurrence of incontinence-associated dermatitis (IAD) ranged from 6 to 42 days, with the median of 13 days.
Recent discussion on IAD and implications for research points to the need for clinical evidence on its differentiation from pressure injury.4 Accurate differential classification of IAD versus Stage 1 or Stage 2 pressure injury is challenging for both expert and nonspecialty nurses. According to a 2010 consensus panel,5 IAD is frequently misclassified despite the fact that ischemia is not the cause. In the skilled nursing facility (SNF) setting, this may lead to incorrect high pressure injury prevalence or incidence rates and resultant federal and/or state survey deficiencies. The Centers for Medicare and Medicaid Services6 publishes these findings for public review, and poor quality outcomes such as these impact Medicare reimbursement.
A cross-sectional study7 and a retrospective cohort study8 have shown that using absorbent products such as pads and briefs is the most common urine collection method in nursing homes; they are used by 56.1% to 67.6% of residents with urinary incontinence. Reports in the literature indicate that switching to moisture-wicking underpads results in a decrease in moisture-associated skin issues; for example, findings from a quality improvement study9 noted disposable pads helped maintain dry skin, thus preventing moisture-associated skin dermatitis (MASD) as well as pressure injuries in hospitalized patients. Using a cluster randomization method in a randomized clinical trial, Francis et al10 compared standard moderately absorptive reusable underpads to disposable high-absorbant underpads in hospitalized patients. Although no statistical differences were noted in IAD rates, hospital-acquired pressure injuries were lower (P = .02).
No studies have been published that compared high-absorbant underpads to briefs or nonpermeable containment products in the long-term care setting with bedbound residents. The primary purpose of this multicenter, prospective study was to evaluate if substituting standardly used products with a disposable high-fluid capacity underpad (Wings™ Quilted Moisture Vapor Permeable Underpad; Cardinal Health, Mansfield, MA) would affect incidence and severity of IAD. Specifically, the study pad replaced products such as single-use disposable briefs and standard nonvapor, permeable, moderately absorptive underpads usually used for bedbound, chairbound, or ambulatory SNF residents who were not toileted at night or when they were confined to bed longer than 2 hours.
Participants. This prospective, descriptive, multicenter, study was conducted in 3 Connecticut SNFs. SNF residents presenting with IAD and those without but at risk for IAD were enrolled. A complete list of inclusion/exclusion criteria is shown in Table 1. Enrolled participants were assessed weekly for 4 weeks. This timeframe was chosen to allow data collection at 5 points: baseline, week 1, week 2, week 3, and week 4. Data from residents who dropped out or were unable to complete the study due to hospitalization or death were excluded from analysis.
Consent. An independent Institutional Review Board (Allentown IRB Regulatory and Technical Associates, Old Lyme, CT) reviewed and approved the study protocol. Residents who agreed to participate and provided written informed consent were enrolled. Residents unable to understand or provide written consent were enrolled after their designated legal representative agreed to the study procedures and provided written consent for participation.
Procedure. Following approval of the study protocol, the principal investigator educated facility staff on participant selection, clinical procedures, and documentation requirements. In addition, the investigator conducted training on the importance of differentiating between IAD and pressure injury. At study initiation, the investigator utilized didactic method and visuals (pictures) comparing and contrasting the 2 clinical entities. All licensed nurses (RNs and LPNs) on all 3 shifts in each facility received training. Staff then referred male and female residents who met inclusion/exclusion criteria (see Table 1) to the investigator. After obtaining consent and before enrollment, the investigator assessed each potential participant for eligibility and determined if IAD was present. Following enrollment, the investigator performed assessments at baseline and weekly for 4 weeks, taking photographs for comparison purposes.
Facility staff placed each participant on the study pad when time in bed was expected to be longer than 2 hours and then conducted wetness checks every 2 hours; this benchmark was chosen to coincide the wetness checks and subsequent incontinence care with pressure injury prevention care activities at the participating facilities such as routine turning and repositioning. If any amount of wetness was felt on the study pad, staff changed it and provided routine incontinence skin care per facility protocol, including cleansing using a pH balanced liquid soap, moisturizing using a lotion, and applying a zinc-based moisture barrier. Particular skin care products differed among facilities, but they remained unchanged before, during, and after the study.
In addition, staff followed the usual turning and repositioning plan established for each participant. While providing incontinence care over the 4-week period, facility staff observed the skin for any new occurrences of IAD or other types of damage. Any changes were reported to the investigator within 24 hours.
Staff recorded the type and number of study products used daily on each participant on a pen-and-paper Product Placement Report form kept at the participant’s bedside and totaled use on a weekly basis. Facilities provided an itemization of containment products that constituted “usual care” for each participating resident. In 2 facilities, usual care consisted of a brief changed every 2 hours during the night and 2 disposable pads. In the third facility, briefs were used for men and women deemed as “heavy wetters” (defined as requiring linen change in addition to a change of brief). Otherwise, reusable cloth pads were the norm.
Tools and data collection. The principal investigator utilized a remote data capture system to complete electronic Case Report Forms. All data were managed in a secure database that provided content control and auditability, ensured content security, and complied with all applicable regulatory guidelines. Identifiable participant information was not recorded in the database. A unique subject identification number was allocated to each participant that also indicated enrolling site.
IAD risk was based on contributing factors as itemized in the Perineal Assessment Tool (PAT), a 4-item instrument based conceptually on the 4 determinants noted in perineal skin breakdown: intensity per type (eg, solid stool, liquid stool, urine) and duration of irritant, perineal skin condition, and contributing factors such as Clostridium difficile infection, poor nutrition, or tube feeding. Subscales are rated from 1 (least risk) to 3 (most risk), with a total score range of 4 to 12. Persons with scores 7 or above are considered high risk and scores <6 are considered low risk for perineal breakdown. Interrater reliability of the PAT was acceptable with a calculated value of the Pearson product-moment correlation r = .970, 95%, confidence interval = .923–.988, and P = <.0001.11
On enrollment, the investigator recorded participant demographic data, including gender, age, race, ethnicity, height, weight, and body mass index. The baseline skin assessment included known history of IAD (type, location, duration, and moisture frequency). Skin was assessed using the IAD Skin Condition Assessment Tool (SAT), an instrument that generates a cumulative severity score based on area of skin affected, degree of redness, and depth of erosion.12 The total SAT score ranges from 0 (no IAD) to 10 (severe IAD). The tool contains 3 domains: area of skin breakdown (score 0-3); skin redness (score 0-3); and erosion (score 0-4). Although reliability and validity have not been established, it was selected and deemed appropriate for use in the SNF setting owing to its use in a randomized, controlled, long-term care incontinence study.13
Facility staff manually reported product usage data and results of wetness checks using the Product Placement Form. The investigator verified congruence between recorded data and pad counts (pads were kept at each participant’s bedside) and reviewed the medical record to determine congruence between data recorded on the Product Placement Report form and documentation of staff performance of wetness checks and incontinence care.
For each facility, the investigator collected IAD and pressure injury prevalence rates for the 1-month period before study initiation, the time of the study duration, and at 1-month following study completion. IAD and pressure injuries were reported daily to the infection control nurse who reviewed the medical records and confirmed the documentation with a visual inspection of the patient. Weekly and monthly incidence for each unit and the entire facility were compiled and presented at quality and medical staff meetings. Incidence rates then were calculated and reported at monthly quality meetings. All facilities participating in the study calculated the number of residents (in percentage) with both pressure and IAD on a daily basis to reflect “real-time” incidence.
Data analysis. Staff entered data into the participant’s medical record. The investigator transferred the data onto Case Report Forms that then were sent electronically to a centralized secure database for analysis.
Descriptive statistics were used to summarize demographic and clinical characteristics of the enrolled participants. Number of available observations (n), mean, standard deviation (SD), median, and minimum and maximum values were assessed, along with the frequency and percentage of participants assigned to either IAD present or IAD risk category.
The PAT and IAD Skin Condition Assessment Tool scores were tabulated at baseline and week 4. Because this was not a controlled, randomized comparison study, a formal sample size calculation based on statistical need was not performed. Data from the 3 facilities were aggregated for analysis because too few residents participated to evaluate outcomes per facility.
IAD-positive participants, regardless of severity at baseline, were analyzed using the McNemar chi-squared test for paired or dependent data. Data were assessed for each participant with IAD and IAD diagnosis change between baseline and post-procedure timepoints, which identified concordant pairs (no change in IAD diagnosis between baseline and post-procedure) and discordant pairs (change in diagnosis or severity between baseline and post-procedure). Discordant pairs could be in both direction (IAD=YES at baseline to IAD=NO post-procedural, or IAD=No at baseline then YES=post-procedure). The McNemar test then was calculated using these discordant and concordant pairs. Because pressure injury was not a variable studied, it was not analyzed. However, the investigator reviewed the weekly infection control data to see who had IAD.
A total of 43 residents met inclusion criteria, provided consent, and were enrolled. Three (3) dropped out voluntarily after the baseline visit and were excluded from analysis. The remaining 40 enrolled residents completed study requirements and qualified for evaluation (12 from facility 1, 17 from facility 2, and 11 from facility 3), including 31 women (78%). Participant mean age was 83 (range 62–98) years. Ambulatory status at baseline was 2 bedbound, 6 mostly bedbound but occasionally able to move to a chair, and 32 wheelchair-dependent patients. At the time of enrollment, 25 participants presented with IAD; 15 had intact skin but were determined to be at risk of developing IAD; 36 had a reported known history of IAD. Of those, the proportion of participants with scores indicating a change from IAD-positive to IAD-negative between baseline and post procedures (6 IAD positive post-procedure and 19 IAD-negative post procedure) was significant for all time points: from 16 (62.5%) IAD-positive at baseline to 9 (37.5%) at week 1 (P = .0016); 8 (35.0%) from week 1 to week 2 (P = .0023); 7 (32.5%) from week 2 to week 3 (P = .005); and 4 (15.4%) at week 4 (P <.0001) (see Figure 1). The overall reduction in IAD severity from a mean score of 3.3 ± 1.7 at baseline to a mean score of 0.7 ± 1.4 at week 4 also was significant (P <.001). The mean PAT score (ie, risk for perineal skin breakdown) for these 25 participants decreased from 8.7 at baseline to 7.5 at week 4 (see Figure 2). The 15 participants without IAD at enrollment maintained intact, nondamaged skin at all data collection time points from baseline to week 4. PAT score risk levels decreased from high (7 or greater) to low (6 or less) as a result of a specific reduction in the duration of irritant exposure category in these participants at week 4 (see Figure 2).
Impact on IAD rates. Facility IAD rates began to increase after the investigator completed staff training on the importance of differentiating between IAD and pressure injury. As a serendipitous finding, investigators noticed (as did the infection control nurse) the IAD and pressure injury rates reversed. IAD rates continued to increase in each facility for the study duration as follows: facility 1 from 0% to 4.5%; facility 2 from 0.05% to 3.4%; and facility 3 from 0.0% to 0.3%. Conversely, reported pressure injury incidence rates increased in all 3 facilities for the 1-month post study follow-up period: facility 1 from 1.2% to 3.8%; facility 2 from 1.2% to 1.5%; and facility 3 from 0.6% to 0.9%, while IAD rates decreased in facility 1 from 4.5% to 2.3%; in facility 2 from 3.4% to 2.9%; and in facility 3 from 0.3% to 0.0%.
The study focused on evaluating the clinical impact of a disposable, high-fluid capacity underpad on IAD rates in SNFs used for residents with incontinence who were in bed longer than 2 hours. The analysis revealed significant differences in the reduction of IAD in the 25 participants enrolled with IAD. In addition, the 15 participants with intact skin who were identified to be at risk of IAD maintained intact, nondamaged skin between baseline and week 4.
Based on the authors’ observations, absorbent products are widely used in SNFs for containing urine and feces; bed- and chairbound nursing facility residents wear diaper-type briefs. Some residents who are ambulatory during the day and not toileted during the night also wear briefs when confined to bed. Improper application of these products, using an incorrect size, or not changing a brief in the recommended timeframe may result in MASD.14 It has been reported in a multicenter prospective surveillance study15 (N = 118) and a randomized trial16 (N = 68) that absorbent products can further increase the risk of skin problems, inflammation, and infections, especially if used inappropriately.
Based on the authors’ clinical experience, many hospitalized patients with incontinence who are bed- and/or chairbound typically do not wear diaper-type briefs. Increasingly, hospital staff use disposable underpads with high fluid capacity designed to wick moisture away from the skin.10,17 In the authors’ experience, relatively little attention is paid to the problems associated with using these and other nonpermeable containment products while SNF residents are in bed longer than 2 hours.
The International Organization for Standardization (ISO) document18 Urine-absorbing aide – General guidelines on evaluation describes factors that should be considered when evaluating adult incontinence absorbing aids. This document stresses that no research has identified a single product proven suitable for every user. ISO clinical researchers19 have concluded that, due to the considerable variability in individual user preference, patient-centered management of incontinence may best be achieved by allowing users to choose combinations of designs for different circumstances (eg, nighttime versus daytime usage). The current findings suggest a high-fluid capacity absorbent pad used by SNF residents who are in bed more than 2 hours may be a helpful component of an individualized incontinence management program.
During the study, facility-reported IAD rates increased in each facility while pressure injury incidence rates decreased. The inverse was true 1 month post study: pressure injury incidence rates increased while IAD rates decreased. The authors believe this was a result of the staff education on distinguishing between IAD and pressure injury provided by the investigator before and during the study. The investigator noted that the participating facilities did not believe IAD was a problem among residents until educated on the subject. The inverse findings noted in the 1 month follow-up period suggest ongoing education is essential to reinforce the differentiation between IAD and pressure injury.
Gray et al20 observed that IAD is frequently misclassified as a pressure ulcer. Trevellini and Smith17 describes a performance improvement project initiated in a 750+ bed acute care facility ICU to empower the staff nurse to identify and classify skin integrity issues according to etiology and implement evidence-based nursing strategies to prevent IAD, fungal rash, and pressure injury. In this study, 100 wound care nurses were asked to review 9 unique wound photos and determine whether the primary etiologic factor was pressure, moisture, IAD, or skin tear. The analysis revealed that the agreement between the 100 respondents for the 9 photos was only 17% better than chance alone.
A randomized controlled trial21 with a convenience sample of more than 1200 Belgian, Dutch, British, and Portuguese nurses asked participants to classify photos of pressure injuries and IAD; in the post test, the percentage of correct assessments of IAD was significantly higher in the education group (70.7%) versus 35.6% in the control group (P <.001).
The current study supports other research findings that generalist nurses are not well versed in determining etiology of buttock wounds.22 Previous studies did not examine interventional results over a period of time. In this study, educational efforts had a short-lasting effect. Future research is indicated to determine the most effective method to improve nurses’ ability to identify and distinguish IAD from pressure injury. Last year, penalties imposed on Medicare and Medicaid certified nursing homes (for all deficiencies combined) ranged from $1000 to more than $354 000.6 Therefore, it is critical that IAD is not erroneously documented as a pressure injury.
A feasibility study conducted by researchers in the UK23 concluded IAD instruments are too time-consuming and linguistically complex for use in routine clinical practice in nursing homes. These findings suggest that a simple rating tool combined with photographs to illustrate the different severity categories may be suitable for daily monitoring of skin health in nursing home residents, at least to address some of the issues noted in the current study.
Because this was not a randomized controlled study, findings cannot be applied to the general population of SNF residents who are incontinent. The study protocol may have resulted in more frequent wetness checks, turning, and repositioning than before study initiation. Also, the education that focused on differentiating between IAD and pressure injury may have impacted the reported IAD and pressure injury incidence rates.
No validated tool to reliably detect the presence of IAD and measure its severity has been deemed superior in the clinical setting. Clinical tools that provide objective measurement of IAD severity are limited, as are validated skin health tools for determining intervention outcomes in trials such as this, tempering the current outcomes.
All participants were provided a pad made by a single manufacturer. Therefore, the influence of pads from different manufacturers on IAD or pressure injury prevalence or incidence rates was not addressed. In addition, pad change frequency varied for each participant. Thus, no cause and effect can be attributed to a single product. Each SNF resident should have an individualized plan of care to manage incontinence that is based on a number of factors.
Implications for Practice and Research
Although wound, ostomy, continence nurses may be involved in policy regarding the use of incontinence products in the SNF setting, very little evidence is available to support these decisions. Studies such as this, although limited, may be of assistance when developing clinical practice pathways for the use of incontinence containment products or configuring a simple rating tool to assist with identification of IAD and recommending appropriate interventions. The current findings also reinforce the need for education regarding the prevalence of IAD in SNFs and its differentiation from pressure injury. These results support previous conclusions that a simple, valid, and reliable rating tool suitable for routine clinical practice by nurses and other caregivers in nursing homes, is needed.
Using a disposable, high-fluid capacity underpad as replacement for nonvapor permeable containment products for SNF residents in bed longer than 2 hours may impact the severity of IAD when present and reduce its incidence. The current findings support recommendations that studies comparing the effect of various pad types on skin health in older adults are needed to help reduce the incidence of IAD.14,24,25 Because pad function depends in part on the available brand, it is probable that differences in design and composition may affect skin differently.
The inverse impact reported on IAD and pressure injury incidence rates suggests that education focused on differentiating between these conditions would be valuable in the SNF setting. This may lead not only to improved quality of care but also to more accurate federal and/or state survey findings. n
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24. Palese A, Regattin L, Venuti F, et al. Incontinence pad use in patients admitted to medical wards: an Italian multicentre prospective cohort study. J Wound Ostomy Continence Nurs. 2007;44(6):649–654.
25. Bliss DZ, Bland P, Wiltzen K, et al. Absorbent briefs containing curly fiber lower (acidify) skin pH reducing risk for incontinence associated skin damage (IASD). Poster session presented at: WOCN Society and CAET Joint Conference. June 4–8, 2016. Montreal, Quebec, Canada.
Potential Conflicts of Interest: GM Associates received a research grant from Medtronic (Minneapolis, MN) to conduct the study.
Ms. Motta is a reimbursement and clinical consultant as President and CEO, GM Associates, Inc, Loveland, CO. Ms. Milne is an Advanced Practice Wound, Ostomy, Continence Nurse, Connecticut Clinical Nursing Associates, Bristol, CT. Please address correspondence to: Glenda Motta, RN, MPH, 845 Crabapple Drive, Loveland, CO 80538; email: email@example.com.