Cath Lab Digest

P erineal 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.