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An Evaluation of Two Incontinence Skin Care Protocols in a Long-Term Care Setting

Empirical Studies

An Evaluation of Two Incontinence Skin Care Protocols in a Long-Term Care Setting

Index: Ostomy Wound Manage. 2002;48(12):44-51.

   Preserving functional status and promoting quality of life are significant goals of care for residents of long-term care facilities. Management of incontinence and maintenance of skin health are important components of achieving these goals.

   In the long-term care setting, urinary incontinence is common. The 1996 AHCPR Guideline, Urinary Incontinence in Adults: Acute and Chronic Management, estimates the prevalence of urinary incontinence at 50%.1 Recent long-term care studies document a 13% prevalence of urinary incontinence and a prevalence of both urinary and fecal incontinence, also known as urofecal incontinence, of approximately 54%.2 Exposure of the skin to urine and feces that accompanies incontinence increases the risk of skin impairment.

   Incontinence management, a time-consuming and frequently frustrating task, is generally delegated to the nursing assistant. Typically, this intervention consists of changing absorbent products and providing skin care to maintain skin integrity, control odor, and promote comfort and dignity.

   Perineal skin damage secondary to incontinence affects residents and their caregivers. The discomfort associated with altered skin integrity may impair a resident's functional status and quality of life. Skin breakdown also increases care requirements, placing additional responsibilities on the caregiver that can result in caregiver frustration, dissatisfaction, and burnout. Finally, costs of care escalate as additional caregiver time and supplies are required to care for damaged skin.

   In one long-term care facility, residents with incontinence frequently experienced skin damage. The facility's standard incontinence protocol included cleansing the skin after each incontinent episode with soap and water, followed by applying a moisturizer without barrier properties. The author hypothesized that skin breakdown was related to inadequate skin protection from irritants and moisture and proposed revising the protocol to include use of a no-rinse skin cleanser (3M™ Cavilon™ Antiseptic Skin Cleanser, 3M Health Care, St. Paul, Minn.) followed by application of a moisture barrier with durable properties (3M™ Cavilon™ Durable Barrier Cream, 3M Health Care, St. Paul, Minn.). Facility administration requested data to support revision of the existing protocol and consider purchase of cleansing and protective products.

   The purpose of this prospective descriptive study was to compare the effect of two skin care protocols on skin condition, pain, and caregiver time in a long-term care facility.

Literature Review

   Incontinence and skin care. Skin damage resulting from exposure to urine and feces is a well-known complication of incontinence. Berg3 articulated a model of diaper dermatitis development in the infant. He hypothesized that a number of key factors combine to create skin injury. Increased stratum corneum permeability, pH changes, microbial overgrowth with attendant secondary infections, and direct irritation appear to interact within the occlusive environment of an absorbent incontinence product.4,5 This set of factors is thought to have relevance for adults as well. As with other types of nonallergic irritant contact dermatitis, duration of exposure and the nature of the irritant (ie, urine versus liquid stool) determine the severity of the skin's response to a great extent.

   Additional risk of injury is thought to exist for the elderly, as aging affects the stratum corneum's barrier properties.6-8 Once damaged, the stratum corneum and its barrier function recover slower in elderly persons.7-10 This places the elderly at greater risk for repetitive and/or cumulative skin injury11 that can occur when exposure is recurrent or the irritant is highly damaging, such as that seen with diarrhea.
Perineal skin damage, particularly when it results in severe inflammation or partial-thickness skin loss, can cause discomfort. Although interest in the relationship of pain and wounds has increased,12 little is known about the relationship between severity of incontinence skin damage and pain.

   Skin care is considered fundamental to preventing or improving incontinence dermatitis.1 Typical procedures include cleansing to remove irritants followed by drying the skin. Although bar soaps are commonly used, they adversely affect the stratum corneum by altering pH and removing surface lipids.13 This is significant, as normal skin pH is necessary for maintenance and repair of intercellular lipid layers, critical to normal barrier function.14

   Using a pH-balanced liquid perineal cleanser has several clinical advantages. These products minimally disrupt skin pH and ingredients called surfactants (surface active agents) help loosen soil from skin, reducing friction necessary for clean up. Additionally, cleansers are considered labor-saving because they eliminate the need for gathering water and a basin.

   After cleansing, product(s) to protect the skin or create an environment for healing must be selected. Product and protocol selection is often based on a variety of professional and personal experiences and to a lesser extent to an understanding of product ingredient characteristics. Occasionally, product selection is based solely on economic considerations such as cost and contractual purchasing agreements.
Moisturizers may be applied after cleansing to donate moisture, bind moisture within the epidermis, improve skin texture, or prevent evaporative water loss. While moisturizers improve the skin's appearance and plasticity, their ability to reduce the risk of extrinsic damage with respect to incontinence dermatitis is unproven.

   Protective products include moisture barriers (creams, ointments, and pastes) and barrier films. Barrier creams are mixtures of oil and water (emulsions) containing ingredients such as petrolatum, zinc oxide, or dimethicone, alone or in combination, to provide protection from moisture and irritants. Creams may be occlusive or breathable; breathable products are advantageous because they allow normal diffusion of moisture through the skin, preventing potential increased permeability caused by over-hydration of the stratum corneum associated with occlusion. Ointments and pastes are occlusive by definition, but may provide a physical as well as chemical barrier to urine and stool. Barrier films consist of a thin, protective, breathable polymeric film that repels offending agents.

   Incontinence skin care protocols. In its 1996 publication, Urinary Incontinence in Adults,1 the Agency for Health Care Research and Quality recommended use of topical barriers to protect skin from moisture but noted that recommendations were based on expert opinion and that no randomized, controlled clinical trials comparing effectiveness of product categories had been published. Only a few nursing studies have examined the effectiveness of various treatment protocols.

   Byers et al15 studied the effect of various skin care regimens on skin integrity in 10 female residents of a long-term care facility. Soap and water and a no-rinse cleanser were used alone and in combination with a moisture barrier over a 3-week period. Soap and water was the least effective regimen. The no-rinse cleanser used in combination with a moisture barrier was the most effective at maintaining skin integrity.
In a prospective clinical trial involving 15 geriatric patients in a psychiatric unit, Lyder16 evaluated the effect of a structured skin care regimen on preventing perineal dermatitis. A cleanser, moisturizer, and moisture barrier were applied after each incontinent episode. The control group received no treatment, a combination of a cleanser and a moisturizer, a cleanser alone, or soap and water. Incidence was found to be identical in both groups (33%), but the small sample size and lack of a schedule for wetness checks were identified as significant limitations. Interestingly, dermatitis was observed to develop rapidly and only occurred in patients with both fecal and urinary incontinence.

   Cooper and Gray17 compared the impact of two skin care regimes on skin integrity. Patients (N = 93) were randomly assigned to a soap and water cleansing (control) or a multifunctional skin care product (cleanser/moisturizer/barrier) group. Of the soap-and-water group participants, 37% maintained integrity, compared to 66% of the patients receiving the multifunctional product (P = 0.05). Skin deteriorated in 30% of the soap-and-water group versus 12% of the multifunctional group. Statistical significance was not reported.

   McMullen18 examined two treatment protocols for patients with incontinence who had perineal Candida albicans. The control group was treated with an antifungal agent (eg, nystatin, clotrimazole) per physician order two, three, or four times per day after cleansing. The study group received one of the antifungal medications followed by application of a moisture barrier product. Symptoms of patients were resolved and skin cultures were negative after an average of 4.6 days in the study and 7.9 days in the control group. The addition of a moisture barrier product was thought to allow the antifungal preparation to remain effective in the presence of incontinence.

Methods

   To compare the effect of two skin care protocols on skin condition, pain, and caregiver time, a prospective descriptive study was conducted in a 194-bed skilled nursing facility during a 3-week period. Patients experiencing urinary, fecal, or urofecal incontinence were included in the study. Residents with an indwelling catheter were excluded. The participants (N = 32) experienced urinary, fecal, or mixed incontinence and were randomly assigned to either the study or control group. Residents in even-numbered rooms were assigned to the control group; patients in odd numbered rooms were assigned to the study protocol (see Table 1).
Nursing assistants instructed in the purpose and design of the study delivered care. Cleansing was performed after each incontinent episode for both groups. For the control group (n = 14), soap and water was used, followed by the application of a moisturizing lotion. The study group (n = 18) was cleansed with a no-rinse pH-balanced liquid cleanser. During the first incontinent episode of care on each shift, a moisture barrier cream with durable properties was applied. At subsequent episodes, skin was cleansed without additional application of the barrier (see Table 2).

   A single evaluator performed a baseline skin assessment at the beginning of the trial and every 3 days for seven subsequent assessments comprising a 3-week period. A 5-point Likert-type scale was used to evaluate perineal skin condition, with scores ranging from 0 for normal intact skin to 4 for erosion/ulceration of skin. A four-point Likert-type scale was used to evaluate pain associated with skin condition, with scores ranging from 0 for no pain to 3 for severe pain. The number and type of incontinence episodes were obtained from the subject's medical record on the days assessed.

   A time study was conducted to determine amount of caregiver time required for each protocol. The evaluator witnessed and timed nursing assistants over several episodes of care. Average time, in nearest minutes, was obtained for supply gathering and set-up, resident cleansing, and lotion or moisture barrier application.

   Skin condition and pain rating scores were averaged across assessments for each resident to obtain an average rating. These average ratings, as well as the baseline ratings and ratings at completion, were compared between the two groups using the Wilcoxon rank-sum test. Significance of the association of skin condition and pain ratings was assessed using the Mantel-Haenszel chi-square test, which is appropriate for ordinal rankings. Strength of the association was estimated using the Spearman rank correlation coefficient.

Results

   Thirty-two patients were enrolled in the study and data from 31 subjects were analyzed. One subject was dropped from the study as a result of regained continence.

   The control group had a total of 783 episodes of urinary incontinence and 119 episodes of fecal incontinence during the course of the study. This represents an average of 8.3 urinary and 1.1 fecal incontinence episodes per subject per day. This group received an average of 8.2 applications of lotion per day. The study group had a total of 742 episodes of urinary incontinence and 144 episodes of fecal incontinence with an average of 7.1 urinary and 1.1 fecal incontinence episodes per 24 hours. They received an average of 2.8 applications of barrier cream per day.

   Skin integrity. Skin integrity was maintained in nine of 13 (69%) patients in the control group. One patient (8%) experienced slight improvement, moving from a skin condition score of 2 to 1. The skin condition of three out of 13 (23%) of patients in this group worsened or did not improve from an abnormal baseline.

   In the study group, skin remained intact in 13 out of 18 residents (72%). Three patients (17%) experienced improvement of their skin while on the study protocol and moved from a score of 3 to 0 (normal). Two residents (11%) experienced worsening of their skin condition. One subject moved from a score of 0 to a score of 2 while experiencing a significant deterioration in overall health condition, and one subject developed diarrhea and deteriorated from a baseline score of 1 to a score of 3.

   The mean skin condition score of both groups was compared at baseline assessment and at the conclusion of the evaluation (see Table 3). The average baseline skin condition scores of the control and study groups were similar (0.54 and 0.56, respectively). However, by the end of the evaluation, the mean score of the control group increased to 0.77, while the study group decreased to 0.28. The differences in skin condition between the two groups were not statistically significant.

   Pain. Five residents (35%) in the control group reported pain; two residents gave a pain rating of 3 during the entire course of the evaluation. One resident reported improvement, moving from a score of 2 to 1, one resident reported pain worsening from a score of 1 to a score of 3, and one resident had a brief period of pain (rating of 1) with complete resolution (score of 0).

   In the study group, four residents (22%) experienced pain. Three of the residents began the evaluation with pain (score of 2) progressing to a resolution of pain (score of 0) during the course of the evaluation. One resident reported pain worsening from a score of 0 to a score of 2.

   The mean pain ratings for each group at study initiation and completion were compared (see Table 3). Pain ratings at baseline differed but the difference was not statistically significant. The control group reported a mean pain intensity of 0.69; the study group averaged 0.33. Mean score for the control group increased slightly to 0.77 at the end of the evaluation. Mean score of the study group decreased to 0.11 during the course of the evaluation. The differences in pain ratings of the two groups were not statistically significant. A significant association between skin condition and pain was observed (P <0.0001). The Spearman rank correlation coefficient was 0.88, indicating a strong association (see Figure 1).

   Time. Time requirements for set-up and cleansing differed between groups. The control group set-up and cleansing protocol involved collecting supplies, running water, and washing and rinsing the patient and took 13 minutes. The study group required the gathering of supplies and application of a no-rinse cleanser, totaling 5 minutes. Application of the lotion and durable barrier cream took the same amount of time (2 minutes). However, the durable barrier cream only was applied three times per day versus the per-episode application of the lotion. These times did not include redressing the resident or changing linens (see Table 4).
In the control group, skin care required 120 minutes per day (average eight incontinent episodes per day). In contrast, care for the study group totaled 41 minutes (average of seven incontinent episodes per resident) for a difference of 79 minutes over 24 hours (see Table 4).

Discussion

   The purpose of this study was to determine if different incontinence skin care protocols affect skin integrity, pain, and time required for care. Results indicated that more residents in the study than in the control protocol maintained skin integrity or improved. Sample size was too small to detect statistically significant differences in skin integrity. This is consistent with the findings of Byers14 and Cooper and Gray.16

   Although deterioration in skin condition was observed in both groups, twice as many patients in the control group worsened or did not improve from an abnormal baseline. This finding also is similar to that of the Cooper and Gray study. In the study group, both instances of skin deterioration occurred following a change in patient condition (eg, diarrheal stools and significant medical status change). In contrast, none of the patients in the control group whose skin condition deteriorated experienced such an event. Only one resident in the control group improved but failed to resolve to normal skin condition. Residents in the study group improved from more severe impairment (ie, intense erythema with vesicles or other surface defect) to normal skin. Sample size was too small to detect statistically significant differences in skin integrity.

   Not surprisingly, incidence of pain and its severity correlated with severity of skin impairment. Residents with skin condition ratings of 1 to 2 complained of either no pain or slight pain, while those with skin condition ratings of 3 to 4 had moderate to severe pain. In both groups, the severity of pain resolved with skin condition improvement in all participants who reported pain. At the conclusion of the evaluation period, four residents in the control group reported pain; whereas, only one patient in the study group reported pain - consistent with the observed changes in skin condition. This appears to be the first report on the relationship between incontinence related skin impairment and pain in an adult population.

   Considerable differences between the groups in time spent providing skin care both per shift and over a 24-hour period were observed. The soap and water regimen required more than twice as much time as the cleanser protocol. Lotion and barrier cream application required the same amount of time but the latter only needs to be applied three times per day. The time difference between the control and study protocols was 9 minutes per incontinent episode. Using an average of two incontinent episodes per shift, nursing assistants with a care load of seven incontinent residents could save an average of 126 minutes, or 2 hours per shift, using the cleanser and barrier cream protocol. Similarly, for a resident experiencing an average of seven incontinence episodes per day, the study protocol would save 64 minutes per day per resident (41 minutes versus 105 minutes).

   The time saved providing incontinence care would enable available caregivers to redirect efforts to other essential activities such as ambulation, feeding, or social interaction.

Limitations

   A number of factors limit the ability to generalize these study findings. Sample size was small and limited to one facility and the number of incontinence episodes was based on documentation instead of direct observation. Nursing assistants may have been more attentive to caring for patients in the study group as a result of the study and the presence of novel skin care products, and the presence of an observer may have increased the time required for care. Finally, measurement of product and related supplies costs would have helped elucidate the potential economic impact of the two protocols of care.

Conclusion

   The desired outcome of incontinence skin care is prevention of skin damage. The results of this study support use of a pH-balanced skin cleanser in combination with a barrier cream with durable properties to help prevent skin damage and improve the condition of impaired skin while saving nursing time.

   Controlled studies comparing the clinical efficacy of cleansing and moisture barrier products are needed to help clinicians differentiate among the profusion of skin care products available in today's market and determine the effectiveness of different protocols of care. Their economic impact, product costs, and caregiver time also should be evaluated.

   Despite its limitations, the study outcomes obtained provided sufficient evidence to change incontinence care practices in the authors' institution.

Acknowledgment

   The authors wish to thank Sarah Isakson, RN, MSN, CWOCN, for her invaluable assistance in preparing this manuscript.