Clinical and Cost Effectiveness of a Cleanser Protectant Lotion for Treatment of Perineal Skin Breakdown in Low-Risk Patients with Incontinence

   Perineal dermatitis is a potentially serious sequela of urinary and/or fecal incontinence. If untreated, denuded skin may rapidly progress to ulceration and secondary infection,¹ including bacterial (Staphylococcus) and yeast (Candida albicans) infections. This often results in physical discomfort, functioning limitations, and increased treatment costs. Frequent urinary incontinence and/or liquid stool have been cited by several authors^2,3 as causes of perineal skin breakdown; therefore, patients with incontinence may benefit from prophylactic care and expedited treatment of perineal dermatitis.

   Standard protocols for care of perineal dermatitis due to incontinence typically include a cleansing product and a barrier cream (two-step process).^4,5 A new, one-step, cleanser protectant lotion, Baza® Cleanse and Protect™ Lotion (Coloplast Corp., Marietta, Ga.), was recently developed to improve effectiveness and ease of perineal care in patients with incontinence. The primary objective of this multicenter, phase II product evaluation study was to determine the effectiveness of a new cleanser protectant lotion in reducing perineal erythema and pain in low-risk patients with incontinence. The secondary objective of this study was to determine the cost per application and caregiver time of the standard and study products.

Methods

   This study was conducted at two sites. Site One was Vencor Hospital in Minneapolis, Minn. (a long-term, acute care hospital). Site Two was the Minnesota Veterans Home, Minneapolis, Minn. (a skilled, long-term care facility). Institutional review board approval was obtained at each site and standard procedures were instituted to ensure the dignity and rights of study participants.

   Inclusion criteria included: 1) low-risk incontinence defined as a total score of 6 or less on Perineal Assessment Tool⁶ (PAT) (see Table 1); 2) grade 2 or 3 erythema (see Table 2); and 3) ability to provide informed consent or having a family member willing to provide informed consent. Exclusion criteria included: 1) younger than 18 years of age; 2) use of topical corticosteroids on the perineum within 2 weeks prior to enrollment; 3) current use of oral or parenteral corticosteroids equivalent to oral prednisone, 10 mg or greater; 4) known hypersensitivity to ingredients in the study lotion; 5) clinical signs and symptoms of skin infection; and 6) participation in a perineal skin care study within 4 weeks of enrollment. Incontinence was defined as the inability to control urinary and/or fecal output.⁵

   The Perineal Assessment Tool (PAT) is a valid and reliable risk assessment tool developed by Nix6 based on literature review (see Table 1).^2,7-13 The framework for the PAT is based on four factors that are determinants in perineal skin breakdown. These constructs include duration of irritant, intensity/type of irritant, perineal skin condition, and contributing factors that may cause diarrhea. Each subscale reflects degrees of risk factors. All subscales are rated from 1 (least risk) to 3 (most risk). Each rating has a descriptor and a description of each level of the scale. Total scores can range from 4 (least risk) to 12 (most risk).⁶ The PAT was used to categorize patients into high-, medium-, and low-risk patients. Only low-risk patients were eligible to participate in this study.

   After informed consent was obtained, treatment was initiated on day 1. For the following six consecutive days, assessments were performed by two certified wound ostomy continence nurses (CWOCN) with experience in perineal skin care, one at each site. Assessments included the PAT (see Table 1),⁶ Erythema Grading Scale,¹⁴ (a scale used in previous studies) (see Table 2), and Pain Score Scale, a five-point pain rating scale (see Table 2). To ensure interrater reliability of assessments, both research nurses independently viewed and correlated assessments of photographs of eight patients using the PAT and Erythema Grading Scale. Pain was assessed through verbal or physical communication.

   Regular healthcare clinicians provided perineal skin care to participants during the trial. Providers were oriented to the study protocol at inservice training sessions at both sites. Instructions for study product use were as follows: "Spray the affected area with the cleanser barrier lotion. Gently wipe clean, using a soft cloth to remove the debris. Rinsing is not required. Repeat as necessary." In addition, at the time of enrollment, healthcare providers of patients who consented to participate in the study were re-instructed on study product use and study protocol and an instruction sheet was left at the bedside. Each subject received a uniquely identified 8-oz spray bottle of study product. The healthcare provider recorded the number of times the study product was used on the bedside record sheet. All other perineal skin care products were removed from the room.

   Study methods. Statistical analysis. Analysis of data used an intent-to-treat approach. Data were incomplete for three participants. For these patients, data were analyzed using the last observation carry-forward technique. The Sign Test was used to measure the change in the erythema and pain score of each participant. Comparisons were made between scores from day 1 and scores for days 2 through 7. Computations were performed on StatView® (SAS Institute, Cary, NC).

   Economical analysis. Each uniquely identified bottle of study product was weighed pre- and post-study to determine amount of study product used during the 7-day treatment course. All weights were measured on the same scale and recorded by the same individual. The bedside record sheet documented the number of perineal skin care episodes per participant. Study product usage was determined with the following formula: (preweight - postweight)/(number of times product used) = average amount used per application.

   The average amount of study product used per application was calculated for each site. The average cost per application was calculated using the published institutional price. The average amount of standard (prestudy) product used per application was calculated in the same manner.

   Skin care products used in each facility's routine protocol (see Table 4) were evaluated for the amount of product used and the number of applications. Usage of the standard skin care products at each site was calculated by weighing the products pre- and post-use and recording the number of applications during an average day. Cost was calculated using published institutional prices.

   Caregiver time assessments were performed using a stopwatch to measure the amount of time for a regular caregiver to provide perineal skin care. At Site One, time was measured for a regular healthcare provider to perform perineal skin care for three participants using the one-step study product and three participants using their standard two-step process. At Site Two, time was determined for six participants in the same manner. Means with standard deviations were calculated for each site as well as for both sites together.

   Outcome measures. The primary outcome measure was change in erythema, comparing day 1 to day 7 scores. Erythema was graded using the Erythema Grading Scale (see Table 2). Secondary outcome measures included: 1) change in pain, comparing day 1 with day 7 using the Pain Grading Scale (see Table 2); 2) cost difference between the study regimen and site standard protocols; and 3) caregiver time difference between the study regimen and site standard protocols.

Results

   Of the 66 patients screened for study participation, 47 did not meet study criteria. Of the 19 subjects who met entry criteria, 10 were enrolled at Site One and nine at Site Two. Demographics of participants are listed in Table 3. The average PAT score at baseline was 5.9.

   Three patients presented protocol violations during the study. Of the three, two developed PAT scores greater than 6 during the study. On day three, one patient had a PAT score of 9. Candidiasis, not diagnosed prestudy, was suspected. The patient was withdrawn and treated with a topical antifungal. Another patient had a PAT score of 7 on day 3 and a PAT score 8 on days 4 and 5, with increased erythema. The erythema resolved on day 7, using the trial product. A third patient was transferred on day 3 of the study because of a myocardial infarction.

   Erythema results. By day 7, 18 of the 19 subjects demonstrated a statistically significant improvement in erythema (P < 0.002). Statistically significant improvement was first observed at day 3 and continued throughout the 7-day treatment regimen (see Figure 1). Mean erythema score was 2.3 (± 0.5) on day 1 and 0.6 (± 0.8) on day 7. By day 7, 10 of the 19 subjects (53%) had no evidence of erythema.

   Pain results. Of the 19 subjects, three could not communicate pain. Therefore, scores from 16 subjects were used to calculate mean score differences in pain. A statistically significant (P < 0.01) improvement in pain was noted, beginning with day 3 and continuing throughout the treatment regimen (see Figure 2). Mean pain score was 1.5 (± 1.0) on day 1 and 0.3 (± 0.8) on day 7. By day 7, 12 of the 13 participants who completed the study (92%) reported no pain. No adverse events were reported.

   Cost and caregiver time. Using the one-step protocol yielded a cost savings of $.05 per application for Site One and $.11 for Site Two for an average savings of $0.08 (see Table 5). At $10/hr, a 23-second savings of $.64/episode of perineal care was noted (see Table 6).

Discussion

   All participants tolerated the study product without adverse events. A significant reduction in average perineal erythema and pain scores was observed.

   Although this study was designed to evaluate the effectiveness of the study product for use in low-risk patients with incontinence, it also may be effective in higher risk patients. Participant Number 38 developed PAT scores of 7 to 8 on days 3 to 5. Despite this moderate-risk score, continued use of the study product resulted in an erythema score of 0 by day 7, suggesting that this cleanser protectant product may be effective for treating moderate- or high-risk patients, in addition to those at low risk.

   This study design had several advantages. First, evaluation of study product utilization by regular caregivers simulates "real-life" practice. Second, while several studies have evaluated economic implications of various incontinence regimens,^15-18 including two-step procedures, to the authors' knowledge, this is the first evaluation to address the economics of using a one-step cleanser/protectant product. A cost savings of $0.08 per application with an average of 2.6 episodes of perineal care per day yields an average product cost savings of $55.54 per patient, per year.

   Similarly, a 20% decrease in procedure time would result in personnel cost savings of $0.06 for each episode of perineal care (see Table 6). Combining caregiver ($0.06) and product ($0.08) savings yields a $0.14 cost savings per application. With an average of 2.6 episodes of perineal care per day, use of this one-step procedure for low-risk incontinent patients could save $136 per patient, per year.

   Use of a one-step perineal-cleansing product has several other potential advantages in addition to cost and time savings. Healthcare providers participating in this study commented on the ease and efficiency of use of the study one-step product, especially in removing dye from tube feedings and zinc-based ointments. Also, caregivers are less likely to breech infection control measures when minimal supplies are required (eg, less traffic in and out of rooms to gather additional or forgotten supplies). Perineal cleansing also may be more consistent when regimens are simplified.

   Before this study, the two study sites used a variety of incontinence products without formal guidelines. One clinical site now first identifies the risk for perineal skin breakdown using the PAT. Patients with a PAT score of 7 or less receive the study lotion for cleansing and protection. Patients with a PAT score of 8 to 12 receive the study lotion for cleansing and a skin barrier paste or an antifungal cream.

   The most important limitation of this study was the lack of a control group to compare the outcomes observed to those obtained using standard protocols of care.

Conclusion

   This Phase II, multisite evaluation indicates that the study lotion is a safe, effective, and economical product for treatment of low-risk perineal dermatitis due to incontinence and will likely complement and expand current treatment choices for patients with incontinence. Further controlled, double-blinded studies will be helpful in the future.

Acknowledgments

   The authors are grateful to Stephen E. Bohnenblust Ed.D, Professor, Department of Health, Minnesota State University, Mankato, Minn., for providing the statistical analysis.

   Funding for this study was provided by Coloplast Corp., Skin Care Division, Marietta, Ga.

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