Effect of a Structured Skin Care Regimen on Patients With Fecal Incontinence A Comparison Cohort Study

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1 J Wound Ostomy Continence Nurs. 2014;41(1):1-7. Published by Lippincott Williams & Wilkins WOUND CARE Effect of a Structured Skin Care Regimen on Patients With Fecal Incontinence A Comparison Cohort Study Kyung Hee Park Keum Soon Kim ABSTRACT PURPOSE: The purpose of this study was to measure the effect of a structured skin care regimen for critically ill patients with fecal incontinence. DESIGN: A nonrandomized, quasi-experimental research design (comparison cohort) was used for data collection. SUBJECTS AND SETTING: Seventy-six patients with fecal incontinence, Bristol stool form 5, 6, and 7, and Braden Scale score of 16 or less in the intensive care units (ICUs) at Samsung Medical Center in Seoul, South Korea, participated in the study. METHODS: Of the 76 subjects enrolled, 38 were assigned to the experimental group and 38 to the control group. Participants in the active intervention group were being cared for in an ICU; participants in the comparison group were cared for on cardiac, thoracic surgery, general surgery, and neurosurgical ICUs. A structured skin care regimen was developed and implemented, which included the regular use of a no-rinse skin cleanser, application of a skin protectant, and an indwelling fecal drainage system when indicated. Stool consistency was evaluated via the Bristol stool chart. Nurses trained in data collection determined Incontinence-Associated Dermatitis and its Severity (IADS) scores and assessed the perianal and sacral skin for occurrence of pressure ulcers daily over a 7-day period. RESULTS: Patients in the intervention group had significantly lower IADS scores ( t = 4.836, P <.001) than subjects in the control group and were less likely to develop a pressure ulcer than were patients in the control group (5 vs 19, χ 2 = , P =.001). Patients with higher IADS scores were significantly more likely to develop a pressure ulcer (OR = 1.168, 95%CI = ). CONCLUSION: A structured skin care regimen decreased IADS scores and occurrence of pressure ulcers. Higher IADS scores were associated with an increased risk for development of pressure ulcers. KEY WORDS: fecal incontinence, incontinence-associated dermatitis, Incontinence Associated Dermatitis and its Severity (IADS) instrument, pressure ulcer, skin care. Introduction Incontinence-associated dermatitis (IAD) is defined as erythema of the skin when exposed to urine or stool; it is often accompanied by erosion of the skin and cutaneous candidiasis. 1 A pressure ulcer (PU) is defined as localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure in combination with shear according to joint guideline from National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel. 2 The etiology of IAD differs from that of a PU, 1 but these conditions often coexist. 3 Maklebust and Magnan 4 reported the frequencies of risk factors in 270 patients with PUs. Among the 270 patients with PUs, 153 patients (56.7%) had fecal incontinence, which was the second most frequent risk factor after impaired mobility (235/270, 87%). Analysis revealed that persons with fecal incontinence were 22 times more likely to develop a PU as compared to persons without fecal incontinence. The nature of the relationship between IAD and PU is not well understood, but existing research suggests that skin exposed to urine, stool, or affected by IAD is less tolerant to pressure, friction, and shear. 5, 6 Based on knowledge of this association, clinical practice guidelines for PU prevention include implementation of a structured skin care program. Several studies have shown that implementation of a regular program reduces the incidence of PU on the sacrum and buttocks. 7-9 Kyung Hee Park, MSN, RN, CWOCN, KGNP, Director of Samsung Medical Center International Wound Ostomy Continence Nursing Educational Program, Department of Nursing, Samsung Medical Center, Seoul, South Korea. Keum Soon Kim, PhD, RN, Professor, College of Nursing, Seoul National University. Seoul, South Korea. The authors declare no conflict of interest. Correspondence: Kyung Hee Park, MSN, RN, CWOCN, KGNP, Samsung Medical Center International Wound Ostomy Continence Nursing Educational Program, Department of Nursing, Samsung Medical Center, 50 Ilwon-dong, Gangnam-gu, Seoul, South Korea ( khparksmc@skku.edu ). DOI: /WON Copyright 2014 by the Wound, Ostomy and Continence Nurses Society J WOCN January/February

2 2 Park and Kim J WOCN January/February 2014 While the prevalence of incontinence among intensive care unit (ICU) patients is high, this issue is often relegated to a lower priority owing to the critical nature of other issues. 10 We observed a similar pattern of prioritization at the Samsung Medical Center. In 2011, the chief WOC nurse at Samsung Medical Center (KHP) developed and implemented a structured skin care program for patients in the ICU who were experiencing fecal incontinence; this program incorporated evaluation via the Incontinence-Associated Dermatitis and its Severity (IADS) Instrument. 11 The aims of this study were to evaluate (1) effect of a structured skin care regimen on the development and severity of IAD, (2) effect of the structured skin care program on PU development, and (3) the relationship between IADS scores and PU incidence. Methods Data were collected using a nonrandomized comparison cohort design. The intervention was a structured skin care regimen. The main study outcomes were mean IADS score and PU development. The comparison group was managed by the institutions standard skin care protocol, which did not address the prevention and treatment protocols of incontinence-associated dermatitis for fecal incontinence patients. Subjects were recruited from 5 ICUs within Samsung Medical Center, located in Seoul, South Korea, between April and July Inclusion criteria were fecal incontinence with Bristol stool form 12 5, 6, or 7 and no IAD and PU on baseline skin evaluation. Study procedures were reviewed and approved by the institutional review board of Samsung Medical Center. To avoid confusion, the experimental group and the control groups were assigned to different ICUs. Thirty-eight patients in the experimental group were enrolled from medical ICU, and 38 patients from the cardiac care unit, thoracic surgery unit, and neurosurgical ICUs composed the comparison group. Intervention A preliminary skin care protocol was developed based on literature search. Content validation was performed by 2 WOC nurses, 1 critical care nurse, and 1 dermatologist. Each member reviewed the protocol and assigned a score from 1 to 5 to the action items; a content validity ratio was then calculated using Lawshe s method. 13 The final protocol ( Table 1 ) was limited to items with a score of 4 or higher scores out of 5 in the validity test were included into the structured skin care protocol used for the experimental group. The preliminary skin care protocol comprised 31 items; 1 item with a content validity ratio less than 0.99 was discarded. The skin care protocol (intervention) included assessment of stool consistency and perianal skin, use of a no-rinse skin cleanser (Elta Cleansing Foam, Swiss-American Products, Inc, Carrollton, Texas), generic (nonbranded) moisturizer, TABLE 1. The Structured Skin Care Regimen for Incontinent ICU Patients Assessments 1. Regular skin assessment on admission 2. Regular skin assessment at repositioning 3. Regular skin assessment at Braden Scale scoring 4. Special skin assessment of high-risk patients (high-frequency diarrhea, etc) 5. Special skin assessment of patients with deteriorating skin condition 6. Feces assessment: Assessment of feces: Bristol stool type, frequency Interventions 7. Avoid wrapping the buttocks with diaper or brief when patients are on bed 8. Frequent change of linen 9. Use absorptive pad 10. No massage on erythema 11. Do not lie on the side of erythema 12. Initiate structured skin care immediately after incontinence 13. Mild washing: minimize friction damage. No scrubbing 14. Disposable wet tissue instead of cloth towel 15. Cleanse perineal skin with Elta cleansing foam 16. Gentle drying in case water and disposable tissue are used for washing 17. Apply moisturizer within 2-3 min after bathing 18. Avoid moisturizer with high concentrations of humectants (urea, glycerin, a-hydroxy acids, lactic acid) 19. Apply moisture barrier 20. Keep skin care products bedside to improve compliance 21. Use Anal Plug and FlexiSeal immediately before any skin damage occurs 22. Use Anal Plug to patient with Bristol stool type 5 and Use FlexiSeal to patients with Bristol stool type Minimize diarrhea with the consult with nutritionist and doctors 25. Mild erosion: apply liberal amount of skin protectant to cover the affected skin area 26. Treat areas of cutaneous candidiasis with antifungal agent followed by skin protectant 27. Erosion with exudate: Apply hydrocolloid paste with border foam dressing 28. Consult with expert when no improvement is made in 1 week 29. Educate all care providers on structured skin care regimen 30. Avoid the risk of cross contamination: write patient's name on products not to be used in other patients Abbreviation: ICU, intensive care unit. Copyright 2014 Wound, Ostomy and Continence Nurses Society. Unauthorized reproduction of this article is prohibited.

3 J WOCN Volume 41/Number 1 and a skin protectant (Elta SEAL Moisture Barrier, SwissAmerican Products, Inc, Carrollton, Texas). Adult containment briefs were not included in the protocol in order to minimize moisture exposure. Liquid fecal incontinence was immediately addressed with a containment device (Anal Plug, Coloplast A/S, Humlebak, Denmark) or stool diversion system (FlexiSeal, ConvaTec, Greensboro, North Carolina). The protocol also included a pictorial description of Bristol stool type 5 (soft blobs with clear-cut edges, passed easily), 6 (fluffy pieces with ragged edges, a mushy stool), Park and Kim 3 and 7 (watery, no solid pieces, entirely liquid)12 to aid nurses in assessment of the stool. The treatment of the skin erosion was described in the protocol. Self-adherent foam dressings (Mepilex Border, Mölnlycke Healthcare, Gothenburg, Sweden; Allevyn Thin, Smith & Nephew Medical Ltd, Hull, England) were applied to the eroded skin area and paste (Stomahesive Paste, ConvaTec, Greensboro, North Carolina) was applied to the edge of the dressing to prevent contamination by stool. Antifungal agent (Canesten Powder, Bayer Korea, Seoul, Korea) was applied to IAD suspected of the complication with candidiasis. The FIGURE 1. The identifying Incontinence-Associated Dermatitis (IAD) and its Severity instrument.11 Reprinted with permission. All copyright requests should be made to the copyright holder. JWOCN-D R1.indd 3 11/12/13 5:03 PM

4 4 Park and Kim J WOCN January/February 2014 TABLE 2. Subject Characteristics Variables Experimental (n = 38) Control (n = 38) P (N = 76) Gender, n (%) Male 18 (47.4) 22 (57.9).358 Female 20 (52.6) 16 (42.1) Age, M ± SD, y 66.2 ± ± st major problem for ICU admission, n (%) Respiratory 19 (50) 8 (21.1) Neurovascular 11 (28.9) 11 (28.9) Cardiovascular 2 (5.3) 12 (31.6) Digestive 6 (15.8) 7 (18.4) Abbreviation: ICU, intensive care unit. skin and fecal incontinence of the subjects were assessed every 2 hours. The preexisting protocol was operationally defined for this study as standard care. The standard care protocol did not address frequency or specific focus of skin assessment in incontinence patients. It did not specify interventions for managing diarrhea, although treatment suggestions for managing skin erosion were suggested in the protocol. When this study was initiated, the majority of ICU patients were managed with adult containment briefs. The use of fecal containment devices, fecal management systems, skin protectants, or moisturizers was based on nursing staff preference. Instruments The IADS instrument was used to evaluate incontinenceassociated dermatitis ( Figure 1 ). This tool requires the nurse to assess erythema, rash, and skin loss in 13 locations including the perianal, perineal, perigenital skin, and inner thighs. The IADS instrument has undergone initial validation; in addition, initial intraclass correlation was We obtained approval for the use of the IADS instrument from Borchert and colleagues. 11 Pressure ulcer occurrence and staging were based on the taxonomy of the National Pressure Ulcer Advisory Panel. 14 Pressure ulcers were defined as stage 1, 2, 3, 4, suspected deep tissue injury, and unstageable. The Bristol Stool Scale was used to aid nurses to assess stool consistence and accurately identify diarrhea. 12 The instrument classifies stool consistency based on 7 categories. Types 1 and 2 indicate hard stools. Type 3 and 4 indicate normal stools. Types 5, 6, and 7 indicate liquid stool with or without smaller formed or semiformed fecal content. Study Procedures Four 1-hour long educational sessions on the structured skin care protocol were provided for nurses who assessed and cared for patients. Educational techniques included a PowerPoint presentation, demonstrations of the products and devices, and oral explanations of the protocol. The knowledge of the ICU nurses was tested with 5 example cases and was appropriate to carry out the structured skin care protocol. Ten primary wound care nurses (PWNs), 5 for the experiment group and 5 for the control group, were educated on how to score the IADS instrument and to assess feces based on Bristol Stool Scale. Interrater reliabilities of IADS scores and Bristol Stool Scale of the 10 PWNs were and 0.939, respectively, on 5 computer-presented cases. Wound care nurses, who are institutionally qualified nurses by completing middle-level courses of wound care are giving primary wound cares at their units under the supervision of WOC nurses. The structured skin care protocol was attached to the nursing cart and its implementation was marked on a card by the ICU charge nurse. Wound care nurses or the principal investigator (K.H.P.) completed the IADS and checked for a new PU once a day for 7 days. The highest IADS scores and PU stage documented during the 1-week period were used for data analysis. Statistical Analysis Data were analyzed using Predictive Analytics SoftWare version 18.0 (SPSS Inc, Chicago, Illinois). Subject characteristics, IAD, and PU risk factors in the experimental group were compared with the standard care group using χ 2 or independent t -test. The IADS scores of the experimental (intervention) group were compared with those of control group using the independent t -test. Pressure ulcer development in experiment and control groups was compared using the χ 2 test. The relationship between IADS scores and PU development was analyzed with logistic regression. Receiver operating characteristic (ROC) curve analysis was performed to determine whether IADS scores could be used to predict PU development. Results The mean age of subjects was 68 ± 14 years (mean ± SD); 67% were aged 65 years or older. Slightly more than half (n = 40; 53%) were male. Most subjects (60.5%) had Bristol stool form 7. All 76 subjects had Braden Scale score of 13 or less, indicating that all participants were at risk for PU development. Homogeneity of the experimental and control subjects was tested by comparing demographic characteristics, IAD risk factors, and PU risk factors in the 2 groups using χ 2 or independent t -test. No significant differences were found between the groups ( Tables 2 and 3 ). Analysis of Intervention The structured skin care protocol reduced the severity of IAD in the structured skin care group compared with that of the Copyright 2014 Wound, Ostomy and Continence Nurses Society. Unauthorized reproduction of this article is prohibited.

5 J WOCN Volume 41/Number 1 Park and Kim 5 TABLE 3. Comparison of Pertinent Clinical Characteristics of IAD and PU in the Structured Skin Care Regimen (Experimental) and Standard Care (Control) Groups Variables Exp (n = 38), M ± SD or N (%) Con (n = 38), M ± SD or N (%) P (N = 76) Urinary Continence 5 (13.2) 8 (21.1) Incontinence with indwelling catheter 33 (86.8) 30 (78.9).361 Average intensity of fecal irritant a Type 5 7 (18.4) 6 (15.8) Type 6 8 (21.1) 17 (44.7).082 Type 7 23 (60.5) 15 (39.5) Average frequency of fecal incontinence (per day) 6 times 26 (68.4) 17 (44.7) 3 times, 5 times 10 (26.3) 20 (52.6) times 2 (5.3) 1 (2.6) Antibiotics 33 (86.8) 36 (94.7).43 Tube feeding 23 (60.5) 16 (42.1).108 Clostridium difficile 5 (13.2) 8 (21.1).361 Cardiac arrest Vasopressive medication for > 48 h Shock b Surgical procedure >8 h General edema/weeping Morbid obesity Malnutrition c Bed rest Liver failure Diabetes mellitus Age > 65 years old Sedatives/paralytics > 48 h Mechanical ventilation > 48 h Quadriplegia or spinal cord injury Nitric oxide ventilation Past history of pressure ulcers Heart drive lines Braden Scale score 11.8 ± ± BMI 22.4 ± ± Serum hemoglobin (g/dl) 9.6 ± ± Serum albumin (g/dl) 2.8 ± ± Total lymphocyte count (/mm 3 ) 926 ± ± Steroid 19 (50) 14 (36.8).247 Abbreviations: BMI, body mass index; IAD, Incontinence-associated dermatitis; PU, pressure ulcer. a Bristol Stool scale. b Septic, hypovolemic, cardiogenic shock. cpre-albumin < 20 (mg/dl), albumin < 2.5 (g/dl) or NPO greater than 3 days.

6 6 Park and Kim J WOCN January/February 2014 TABLE 4. The IADS Scores in the Experiment and Control Group (N = 75) Experiment (N = 37) M ± SD(N) Control (N = 38) M ± SD(N) P-value IADS Score 5.19 ± ± 11.7 <.001 Abbreviations: IADS, Incontinence-Associated Dermatitis and its Severity; M, mean; SD, standard deviation. TABLE 6. Relationship Between the IADS Score and Pressure Ulcers development (N = 75) B SE P OR 95% CI for OR Constant < IADS Score < Abbreviations: IADS, Incontinence-Associated Dermatitis and its Severity; CI, confidence interval; OR, odds ratio; SE, standard error. standard skin care group (5.19 ± 3.41 vs ± 11.7, t = 4.836, P <.001), indicating that the experimental group had less severe IAD than control group ( Table 4 ). Patients managed by the structured skin care protocol were also found to have a lower PU occurrence rate than were the standard care group (13.2% vs 50%; χ 2 = , P =.001) ( Table 5 ). Relationship Between IAD and PU Development Multivariate analysis also found a statistically significant relationship between IADS scores and the development of PUs ( P <.001). Patients with higher IADS scores had a higher likelihood of developing PUs (OR = %CI = ) ( Table 6 ). The ROC curve analysis revealed an area under the curve of.761, suggesting that higher IADS scores are associated with an increased likelihood of developing a PU (sensitivity 70.8%, specificity 6.7%, using a cut-off value of 7) ( Figure 2 ). Discussion Study findings demonstrate that a structured skin care protocol significantly reduced the severity of IAD in the experiment group when compared with standard care. This result is consistent with that of the study of Beeckman and colleagues, 15 who compared a soap and water regimen to a structure skin care protocol, using a 3-in-1 disposable washcloth that included a no-rinse skin cleanser, emollientbased moisturizer, and dimethicone-based skin protectant. We observed that nearly all patients with fecal incontinence had some evidence of IAD based on the IADS instrument. In contrast, Driver 10 reported a 50% occurrence rate in 16 patients with fecal incontinence. Bliss and associates 16 reported a 36% incidence rate among 45 patients with fecal incontinence. These differences may, in part, be related to differences in the instruments used to measure IAD. The IADS instrument recognizes the slightest redness such as pink as IAD and gives a score while the instrument used in Driver s study 10 identified IAD only when the skin was red, weepy, and denuded. Likewise the Perineal Skin Assessment Tool utilized in Bliss s study 16 also failed to identify mild erythema as IAD. Subjects in our study who were exposed to loose stool and demonstrated minimum redness identified as having IAD. The second reason of the high incidence of IAD in this study may be related to characteristics of study participants. Subjects in our study tended to have liquid stools ranked as Bristol stool forms 5, 6, and 7. The occurrence of PU was also lower in the structure skin care versus standard care group ( P =.001). Based on this finding, we hypothesize that the experimental skin care protocol helped reduce the frequency of PU development by preventing IAD and its propensity to compromise tolerance of pressure and shear forces in the sacral area. This TABLE 5. Pressure Ulcer Occurrence in Experimental and Control Groups (N = 76) Group Experimental Group (n = 38), n (%) Control Group (n = 38), n (%) P Developed pressure ulcer Yes 5 (13.2%) 19 (50%).001 No 33 (86.8%) 19 (50%) FIGURE 2. Receiver operating characteristic curve of Incontinence- Associated Dermatitis and its Severity. Copyright 2014 Wound, Ostomy and Continence Nurses Society. Unauthorized reproduction of this article is prohibited.

7 J WOCN Volume 41/Number 1 Park and Kim 7 finding is consistent with statements of the European Pressure Ulcer Advisory Panel that IAD and PUs often coexist. 3 In addition, implementation of aggressive interventions to reduce the exposure of the skin to stool, including the use of an anal plug, or fecal management system may have reduced likelihood of PU development. Multivariate analysis revealed an association between higher IADS scores and development of a PU ( P <.001). Specifically, patients with higher IADS scores (indicating more severe IAD) had a higher chance of developing a PU (OR = 1.168, 95% CI = ) ( Figure 2 ). ROC curve analysis revealed an area under the curve of.761, suggesting that IADS scores might be associated with an increased likelihood of development of a PU. Additional research is indicated to evaluate the relationship between IAD and PU risk. Conclusion A structured skin care program was developed for ICU patients with fecal incontinence. Implementation of the structured regimen decreased IADS scores and the occurrence of PU. Multivariate analysis revealed that higher IADS scores were associated with a greater likelihood of developing a PU. ACKNOWLEDGMENTS We thank K Borchert, MS, RN, CWOCN, ACNS-BC, for permitting the use of the IADS instrument for this study. We thank J. M. Hwang, RN, for the statistical analysis. We also thank J. H. Park, BSN, RN, CWON; K. M. Kwon, MSN, RN; E. S. Back, BSN, RN, CWOCN; M. S. Kim, MSN, RN; and K. D. Jung, MD, for participating in the expert group. We thank K. W. Baek, BSN, RN, COCN; H. J. Do, BSN, RN; M. J. Kim, MSN, RN, CWON; and W. I. Jung, BSN, RN, for assisting with data collection. References 1. Gray M, Beeckman D, Bliss DZ,, et al. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs ; 39 ( 1 ): National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC : National Pressure Ulcer Advisory Panel ; Defloor T, Schoonhoven L, Fletcher J, et al. Statement of the European Pressure Ulcer Advisory Panel-pressure ulcer classification: differentiation between pressure ulcers and moisture lesions. J Wound Ostomy Continence Nurs ; 32 : Maklebust J, Magnan MA. Risk factors associated with having a pressure ulcer: a secondary data analysis. Adv Wound Care ; 7 ( 6 ): Gray M, Bohacek L, Weir D, Zdanuk J. Moisture vs pressure: making sense out of perineal wounds. J Wound Ostomy Continence Nurs ; 34 ( 2 ): Junkin J, Selekof JL. Prevalence of incontinence and associated skin injury in the acute care inpatient. J Wound Ostomy Continence Nurs ; 34 ( 3 ): Lyder CH, Clemes-Lowrance C, Davis A, Sullivan L, Zucker A. A structured skin care regimen to prevent perineal dermatitis in the elderly. J ET Nurs ; 12 : 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 ; 48 ( 12 ): Cole L, Nesbitt CA. Three year multiphase pressure ulcer prevalence/incidence study: a regional referral hospital. Ostomy Wound Manage ; 50 ( 11 ): Driver DS. Perineal dermatitis in critical care patients. Crit Care Nurse ; 27 : Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs ; 37 ( 5 ): Lewis SJ, Heaton KW. Stool Form Scale as a useful guide to intestinal transit time. Scand J Gastroenterol ; 32 ( 9 ): Lawshe CH. A quantitative approach to content validity. Pers Psychol ; 28 : The National Pressure Ulcer Advisory Panel. NPUAP pressure ulcer stages/categories. Accessed March Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, Defloor T. Prevention and treatment of incontinenceassociated dermatitis: literature review. J Adv Nurs ; 65 ( 6 ): Bliss DZ, Savik K, Thorson MA, et al. Incontinence-associated dermatitis in critically ill adults: time to development, severity, and risk factors. J Wound Ostomy Continence Nurs ; 38 ( 4 ): 1-13.