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Empirical Studies

A Review of Perineal Skin Care Protocols and Skin Barrier Product Use

December 2004

    Perineal skin damage secondary to incontinence is painful, preventable, and occurs in as many as 33% of hospitalized adults and 41% of adults in long-term care.1,2

Despite the importance of perineal skin care protocols that seek to improve quality of care through evidence-based interventions for various conditions,3 the quality of and compliance with these protocols have not been examined in current literature. To address this dearth of information, a convenience sampling study was conducted to 1) determine the extent to which 76 perineal skin care protocols are consistent with Wound, Ostomy and Continence Nurses (WOCN) Society Clinical Practice Guidelines; and 2) calculate and estimate the level of compliance related to the use of protective perineal skin barriers to prevent skin breakdown for individuals with incontinence to treat pressure ulcers.

Literature Review

    Exposure to urine and/or feces leads to perineal skin damage. Sgadari et al4 reported the prevalence of incontinence in nursing home residents using a Minimum Data Set-derived from a cross-national database. In this sample of 279,191 residents, the prevalence of urinary incontinence was 46.4%, fecal incontinence was 29.5%, and a combination of urinary and fecal incontinence was 25.6%. Fecal incontinence is estimated to affect 16% to 66% of hospitalized elderly.5

    Perineal skin damage secondary to incontinence ranges in severity and may include erythema; swelling; oozing; vesiculation; and crusting and scaling in the groin, perineum, and buttocks region.5 Multiple potentially harmful variables work together to cause perineal skin injury. Moisture from incontinence alters the skin’s protective pH and increases the permeability of the stratum corneum. An intense irritant such as feces contains bacteria that can permeate the stratum corneum, allowing for secondary infections. The need for frequent cleansing can lead to further pH changes and damage from friction.5,6 Damaged skin is indicative of reduced blood flow or the loss of collagen or elastic fibrous connective tissues — conditions that affect skin nutrition, elasticity, and strength.7 Perineal skin injury may rapidly progress to ulceration and bacterial (Staphylococcus) and yeast (Candida albicans) infections that lead to discomfort and increased treatment costs.8 Additional problems associated with perineal skin damage include diminished quality of life (QOL), increased pain and costs, and pressure ulcer development.6,8-12

    Quality-of-life issues. Incontinence negatively affects QOL by causing vast psychosocial disabilities that influence careers, social experiences, and sexual relationships.9,10 It produces emotions such as fear (of accidents), anxiety, frustration, embarrassment, and depression. Persons with incontinence, especially the elderly, also fear the loss of independence and institutionalization. When the severity of the incontinence increases, emotional distress amplifies, as well as behaviors to conceal it.13 The psychosocial consequences of urinary and fecal incontinence are substantial, distressful,11 and measurable using QOL instruments such as the Incontinence Impact Questionnaire and Urogenital Distress Inventory.10 The dissemination and use of such tools is encouraged because increasing awareness of the consequences of incontinence may alter negative attitudes and behavior toward those who suffer from the condition; plus, healthcare providers might be motivated to seek and implement incontinence prevention and management programs.13

    Pain. The fifth vital sign, pain has gained much-deserved focus in today’s healthcare environment.6,8,9,11 The National Institutes of Health estimate that at least 50% of patients still suffer needlessly from pain. Clinical practice guidelines for pain management have been available since the mid-1980s from organizations such as the American Pain Society and Agency for Healthcare Research and Quality (AHRQ), formerly the Agency for Health Care Policy and Research (AHCPR). However, these guidelines are not widely followed.14

    Pain can lead to depression and increased healing time.14 It has been postulated that pain can actually facilitate the development of pressure ulcers by limiting movement and increasing tissue loads.15 The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) released revised standards for the assessment and management of pain for all patients in healthcare institutions; accreditation is provided only if institutions demonstrate that processes are in place to assess and manage pain appropriately in all patients.16

    The relationship between pain and wounds is well documented; much less is written about pain and perineal skin damage secondary to incontinence. Two recent studies evaluating the effectiveness of skin care products measured the perineal pain of subjects with perineal skin damage from incontinence. As part of a multicenter, phase II product evaluation conducted in long-term care settings, Warshaw et al8 reported that all study patients (N=19) with perineal skin damage secondary to incontinence had pain. In a prospective, descriptive study involving 32 residents of a skilled nursing facility, Lewis-Byers et al11 found a positive correlation (r = 0.88) between pain intensity and the level of perineal skin impairment.

    Pressure ulcers. Incontinence is a major risk factor in the development of pressure ulcers because it reduces the skin’s tissue tolerance by increasing its permeability and decreasing resistance to friction. In addition, the skin’s pH is increased, especially with fecal incontinence, rendering the enzymes in feces more active. Urine and feces together have been found to be more virulent in causing skin damage.13 Protective undergarments can exacerbate the problem by trapping heat and moisture.9 After completing a secondary data analysis involving 270 patients with pressure ulcers, Maklebust et al17 reported that 56.7% of patients with pressure ulcers had fecal incontinence and that patients with fecal incontinence were 22 times more likely to have ulcers than patients without fecal incontinence. Robinson and colleagues18 estimated that the average hospital spends $400,000 to $700,000 annually in direct costs to treat pressure ulcers. According to the AHCPR, the presence of pressure ulcers increases hospital stays up to five times and can cost an additional $35,000 for treatment, depending on the severity and stage of the wound.19 Pompeo20 determined that the cost of treating a hospital-acquired pressure ulcers can be as high as $55,000. The Centers for Medicare and Medicaid Services (CMS), JCAHO, and the AHRQ recognize pressure ulcers as a key indicator for quality of care. With a focus on prevention, new quality initiatives incorporate standards and reimbursement strategies to drive compliance and ultimately improve clinical practice.

    Most experts, including the National Pressure Ulcer Advisory Panel (NPUAP), believe the majority of acquired pressure ulcers can be avoided and support a modified version of the AHRQ Guidelines on pressure ulcer prevention, published in 1992.19 The NPUAP cites prevention as the best way to reduce the unnecessary costs incurred by healthcare system. Studies have shown that when a comprehensive program to prevent pressure ulcers is implemented, including thorough perineal cleansing and consistent application of a moisture barrier, the incidence of sacral/buttock pressure ulcers can be significantly reduced. Clever et al21 conducted a quasi-experimental, retrospective study using data from the medical records of 34 residents with incontinence in a 57-bed long-term care facility. Researchers noted a statistically significant reduction in nosocomial sacral/buttocks pressure ulcers when use of a skin protectant was incorporated into a pressure ulcer prevention program. Lyder and colleagues22 conducted a quasi-experimental study in two long-term care facilities and found a statistically significant decrease in the incidence of pressure ulcers when a comprehensive pressure ulcer prevention program, including the use of skin care perineal skin care, was initiated.

    Protocols and compliance. Protocols to improve quality of care with evidence-based interventions for various conditions exist. They define expected standards of prevention, care, and treatment and serve as educational tools and guidelines for staff. Protocols should be easily accessible, easy to follow, and periodically revised to reflect current practice.3 Nix24 presents a sample Policy and Procedure for Incontinent Skin Care Protocol that is based on current literature (see Table 1). The best-written protocols, however, are ineffective if they are not followed.

    Interventions for prevention and treatment of perineal skin damage should be performed promptly after each incontinent episode. In its Guideline for Prevention and Management of Pressure Ulcers,23 the WOCN includes the following interventions for preventing and treating perineal dermatitis:
  • Establish a bowel and bladder program for patients with incontinence
  • Avoid excess friction on the skin
  • Cleanse skin gently at each time of soiling with pH-balanced cleansers
  • Use incontinent skin barriers as needed to protect and maintain intact skin
  • Select underpads, diapers, or briefs that are absorbent to wick incontinence moisture away from the skin
  • Consider utilizing a pouching system or collection device.

    The Guidelines were designed to support clinical practice by providing consistent, research-based clinical decisions. A panel of experts from various clinical settings reviewed scientific evidence to develop the recommendations. The panel used provisional guidelines that the WOCN and the Wound Healing Society developed by expanding, updating, and elaborating on the work done by the two societies along with the AHCPR (AHRQ). The purpose of the guideline is to improve cost-effective patient outcomes and promote research in the areas where gaps exist between research and practice.

    Compliance with product usage is more likely to occur if the user of the product accepts or likes the product. Product safety, therapeutic activity (effectiveness), and convenience are key aspects of a high-quality product.6 Recent studies also suggest that perineal cleansing and protection may be more consistent when regimens are simplified and “one-step” products are available. When minimal supplies are required, staff are less likely to breech infection control measures and less staff monitoring is required.8,22

Methods

    To ascertain whether skin care protocols conform with WOCN Clinical Practice Guidelines and to determine the extent of compliance with protective perineal skin barrier use to prevent skin breakdown for individuals with incontinence, a convenience sample of perineal skin care protocols was obtained. During a 6-month period of time, information was requested from nurses identified in each facility for their involvement in wound, ostomy, continence issues. Their titles ranged from RN to DON to WOCN. Acute care and long-term care facilities in 32 states were solicited via emails and word-of-mouth. Of the 76 protocols received, 55 (72.3%) came from acute care hospitals and nine (11.8%) were from long-term care facilities throughout the US. Twelve (15.8%) were received without demographic information.

    To compare the protocols submitted, statements were extrapolated from WOCN Clinical Practice Guidelines for the Prevention and Management of Pressure Ulcers.23 A grid was created using statements related to the prevention of perineal skin damage secondary to incontinence. Alternative wording was accepted if the authors deemed it appropriate or similar enough to meet the guideline component. For example, “mild cleanser” was accepted as pH-balanced. The frequency at which each intervention was used was tabulated and percentages were calculated.

    Healthcare Products Information Services (HPIS) data were used to obtain the total amount of skin protectants sold to healthcare facilities.25 Established in 1994, HPIS collects monthly data that captures up to 85% of all sales of disposable hospital supplies from major healthcare product distributors. The information is used to project what is happening in the national market. The data consist of sales that identify vendor name, product code, provider type, unit of measure, and location of product sold based on zip code. The aggregate data provide quarterly analytical reports representing medical supply sales in market segments such as hospitals and nursing homes. Skin protectant spending was estimated using HPIS data and comparing it to urofecal (urinary and fecal) incontinence prevalence data.15

Results

    While some protocols were more detailed and comprehensive than others, the analysis revealed many similarities. Many incorporated similar or identical phrases, which indicate they derived from a common source, probably the AHRQ Guidelines.19 All 76 protocols lacked one or more interventions considered important in perineal skin care (see Table 2). Seventy-five percent (75%) of the protocols included the use of skin protectants as a final step of the incontinence skin care process.

    To estimate skin protectant spending, the authors performed the following calculations: The number of institutionalized elderly is reported to be 1,637,000 people.12 Of 883,980 institutionalized elderly, 54% have urofecal incontinence.5 The total annual spending on skin protectants is $32,727,198.25 Using the HPIS data, the average cost per application of the top five skin protectants sold in the US (year 2002) was estimated to range from 11 to 33 cents per application (average 23.5 cents). Data from HPIS were compared to urofecal prevalence data to estimate actual use of skin protectants for incontinent individuals — the estimated amount spent annually per patient is $37.02 ($32,727,198 ÷ 883,980), or 10 cents per day per patient.

Discussion

    The data suggest that many protocols of care are incomplete and that underutilization of skin protectants is common but no data were available with which to compare current findings. The sample size and sampling method are important limitations in this study. The literature reports a high prevalence rate of incontinence in long-term care but only nine protocols of care reviewed here were from long-term care facilities.

    Measuring compliance to protocols by product usage may be new to perineal skin care; however, the concept is not new in other healthcare arenas. Infection control practices, for example, have been evaluated by examining the use of personal protection equipment. Use of see-through needle disposal containers often reveal compliance with the “no needle capping” rule in infection control.26 Correlating the presence or absence of skin barrier use with the quality of protocols, however, may have limitations. The two sets of data collected in this study are different and a variety of variables (eg, product accessibility, staff acceptance of product, or a lack of education) could influence actual product use.

    Although the scope of HPIS data is limited, it provides an introduction to estimate dollars spent to prevent perineal skin injury. Current data suggest that only 10 cents per day per incontinent patient is spent; whereas, the average cost per application is 23 cents. Research to obtain perineal dermatitis prevalence data and comparisons to determine actual costs per incontinent episode using quality perineal skin care products is needed.

    Table 3 presents a method of estimating a facility’s product utilization and protocol compliance as an alternative, or in addition to, perineal dermatitis prevalence and incidence data. The table lists three incontinent clean-ups as an example (number most applicable to the clinical setting can be substituted) but focus is on the costs of skin protectants only.

    Because the authors postulate that adherence to protocols may be a direct result of caregiver understanding of the factors in play, they recommend organized and rigorous staff education in basic skin care and incontinence management as well as proper use of incontinence skin care products. Nursing personnel responsible for using these products should be solicited for feedback, such as where products are stocked and how accessible they are during the clean-up process. Careful selection of quality incontinence products by a designated committee or skin care specialist also is recommended. Products that combine steps and are easy to use may be necessary to encourage use.

    Validity and reliability testing of evidence-based protocols would be useful as well as programs to educate new staff and periodic competency assessments. Although data and outcome comparisons of incontinence care administered by certified nursing assistants (CNAs) versus licensed nursing professionals are not available, the authors believe that most bedside perineal care is done by CNAs as a result of the national nursing shortage. Therefore, education specifically targeted to CNAs, as well as to licensed nursing professionals who supervise CNAs, is mandatory.

Conclusion

    Caregivers want to provide the best care for their patients and are challenged to provide evidence-based best practices in less time while containing cost. As evidenced by the results of this study, protocol development alone is not enough. Protocols should be assessed for completeness to ensure inclusion of key evidence-based practices (eg, use of perineal skin barriers) and implementation should be documented. Healthcare facilities must develop ways to simplify processes, decrease process variation among staff, and promote compliance to meet these difficult challenges.

1. Lyder C, Clemes-Lowrance C, Davis A, Sullivan L, Zucker A. A structured skin care regimen to prevent perineal dermatitis in the elderly. J ET Nurs. 1992;12:12–16.

2. Lyder CH. Perineal dermatitis in the elderly. A critical review of the literature. J Gerontol Nurs. 1997:23(12):5–10.

3. Fenner SP. Developing and implementing a wound care program in long-term care. J WOCN. 1999;26(5):254–260.

4. Sgadari A,Topinkova E, Bjornson J, Bernabei R. Urinary incontinence in nursing home residents: a cross-national comparison. Age Aging. 1997;26(suppl 2):49–54.

5. Brown DS, Sears M. Perineal dermatitis: a conceptual framework. Ostomy Wound Manage. 1993;39:2–26.

6. Nix, D. Prevention and treatment of perineal skin breakdown. In: Milne C, Corbett L, Dubuc D, eds. Wound, Ostomy, and Continence Nursing Secrets: Wound, Ostomy, and Continence Secrets. Philadelphia, Pa.: Hanley & Belfus, Inc.;2002:373–377.

7. Scardillo J, Aronovitch SA. Successfully managing incontinence-related irritant dermatitis across the lifespan. Ostomy Wound Manage. 1999;45(4):36–44.

8. Warshaw E, Nix D, Kula J, Markon CE. Clinical and cost effectiveness of a cleanser protectant lotion for treatment of perineal skin breakdown in low-risk patients with incontinence. Ostomy Wound Manage. 2002;48(6):44–51.

9. Wagner TH, Patrick DL, Bavendam TG, et al. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996;47(1):67–72.

10. Ubersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess quality of life and symptom distress for urinary incontinence in women: the incontinence impact questionnaire and the urogenital distress inventory. Neurol Urodyn. 1995;14:131–139.

11. Lewis-Byers K, Thayer D, Kahl A. An evaluation of two incontinence skin care protocols in a long-term care setting. Ostomy Wound Manage. 2002;48(12):44–51.

12. The Characteristics of Long-Term Care Users. AHRQ Research Report. AHRQ Publication no. 00-0049, January 2001. Agency for Healthcare Research and Quality, Rockville, Md.

13. Fiers S, Thayer D. Management of intractable incontinence. In: Doughty DB. Urinary and Fecal Incontinence: Nursing Management, 2nd ed. St. Louis, Mo.: Mosby;2000:183–207.

14. Acute Pain Management Guideline Panel. Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma. Rockville, Md: U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research; February 1992. AHCPR Pub. No. 92-0032.

15. Shannon ML, Lehman CA. Protecting the skin of the elderly patient in the intensive care unit. Crit Care Nurs Clin North Am. 1996;8(1):17–28.

16. Comprehensive Accreditation Manual for Hospitals. The Official Handbook (CAMH). Joint Commission on Accreditation of Healthcare Organizations. 1999.

17. Maklebust J, Magnan MA. Risk factors associated with having a pressure ulcer: a secondary data analysis. Advances in Wound Care. 1994;7(6):25,27–28,31–34 passim.

18. Robinson C, Gloekner M, Bush S, et al. Determining the efficacy of a pressure ulcer prevention program by collecting prevalence and incidence data: a unit-based report. Ostomy Wound Manage. 2003;49(5):44–51.

19. Panel for the Prediction and Prevention of Pressure Ulcers in Adults. Clinical Practice Guideline Number 3: Pressure Ulcers in Adults: Prediction and Prevention. Rockville, Md.: U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research, 1992. AHCPR Publication 92-0047.

20. Pompeo MQ. The role of “wound burden” in determining the costs associated with wound care. Ostomy Wound Manage. 2001;47(3):65–71.

21. Clever K, Smith G, Bowser C, Monroe K. Evaluating the efficacy of a uniquely delivered skin protectant and its effect on the formation of sacral/buttock pressure ulcers. Ostomy Wound Manage. 2002;48(12):60–67.

22. Lyder CH, Shannon R, Empleo-Frazier O, McGeHee D, White C. A comprehensive program to prevent pressure ulcers in long-term care: exploring costs and outcomes. Ostomy Wound Manage. 2002;48:52–62.

23. Wound, Ostomy, and Continence Nurses Society. Guideline for Prevention and Management of Pressure Ulcers, WOCN Clinical Practice Guideline Series. Glenview, Ill.: WOCN Society;2003:14.

24. Nix D. An evaluation of 52 incontinent skin care protocols. 18th Annual Clinical Symposium on Advances in Skin & Wound Care. Chicago, Ill. October 16-19, 2003.

25. Incontinent Ointment/Barriers: Skin Care (90-354) in HPIS Trend Report (Dollars) Physician/Alternative Site Markets Class Summary. Spring House, Pa.: Healthcare Products Information Services, Inc.;2002.

26. Makofsky D, Cone JE. Installing needle disposal boxes closer to the bedside reduces needle-recapping rates in hospital units. Infect Control Hosp Epidemiol. 1993;14(3):140–144.

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