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Macerated and excoriated tissues. A randomised controlled trial in wound care. Case Studies. Sylvia Hampton. BSc (Hons) DPSN RGN Research and Tissue Viability Nurse. Eastbourne Hospital NHS Trust. INTRODUCTION The Eastbourne Hospital Trust Research & Tissue Viability nurse (TVN), was concerned with the large number of wounds that became excoriated over peri-wound areas, and approached six companies, searching for an appropriate product to solve the problem. This case study is a direct result of that search. There are significant differences in structure and characteristics of skin of various people of all ages. Skin that is oily, dry, moist, papery or normal will react differently to any mechanical insult applied to it. Therefore, patient’s wounds may be treated in identical ways with one having a successful outcome and another’s healing delayed by complications. Maceration is one of the complications that can occur, caused possibly by a wet discharge from the wound or wound dressing which moistens the viable tissue around the wound. Tissues, softened in this way become easily damaged and have the potential to breakdown more easily, offering an entry for infection. Maceration can occur around a wound or stoma or can be a direct result of faecal or urinary incontinence. Injury caused to tissues from faecal fluid incontinence is particularly difficult to treat as dressings may constantly require removal following each episode of diarrhoea. A literature search revealed very little work had been completed on the problem of maceration and excoriation with only one major reference (Dealey, 1992). The TVN approached six companies for advice and a solution. Various options were offered including skin wipes and creams. However, a new product by 3M called Cavilon( No Sting Barrier Film (NSBF) offered a possible solution. This was acceptable to infection control as it was presented in a one use only package in the form of a swab (“lollipop”) soaked in a film. Cavilon NSBF was primarily produced as a protection for skin from incontinence, however, the TVN believed there was a potential for this barrier film to be used for treatment of macerated peri-wound areas, various types of stoma sites, to increase the adherence of some dressings and to protect patients from skin sensitivities from tape. The following study was developed to establish whether the product would protect skin and promote a healing environment. The purpose of this study was to explore the potential of Cavilon NSBF in reducing maceration and excoriation that sometimes occurs in patients with wounds, stoma sites and on perennial and gluteal maximus areas in faecal and urinal incontinence. The study extended, during the six months, to include sensitivity to dressings and tapes as it was found that Cavilon NSBF reduced erythema and skin damage caused by the adhesive in some products. The aim of the study on Cavilon NSBF was to assess the film’s effect on areas that were difficult to protect. Randomised controlled trials (RCT) in wound care are considered often too difficult to undertake because of many variables such as medical condition and mobility. Each patient is so completely different that, unless a very large sample population is used, it is impossible to show that the product is having an effect on wound healing. Large populations of certain types of wounds can only be found if a multi-centered study is undertaken which can create organisational problems. This study used the patient as their own control by placing the film on one half of the peri-wound with a conventional treatment - such as a barrier cream - placed on the other half of the peri-wound area. Choice of control treatment relied on the patient’s named nurse to dictate. Photographs were taken at dressing changes, preferably daily. This relied heavily on the prescribed and optimum period that the primary dressing should remain in situ. CONCLUSION As there has been very little work completed on the treatment of macerated and excoriated wounds, this RCT has important implications in the treatment of peri-wound areas and any other area affected by maceration and excoriation. Each peri-wound area and each patient with excoriation from diarrhoea showed improvement with the use of Cavilon NSBF and, although the experiment could not be taken to conclusion, which might have demonstrated healing on the experimental side of the peri-wound area and non-healing on the control tissues, it illustrated that there are solutions to the problem of maceration and that further research is necessary. The primary objective of the study had been to find a treatment that would support healing in the surrounding tissues whilst not interfering with treatment of the wound. This was a comparatively small sample number. Of the 62 patients taking part in the study, 61 showed improvement under Cavilon NSBF and 53 patients who survived (85%) went on to complete healing of the macerated tissues when the film was applied to the whole area. Only 2 patients took longer than 3 weeks to complete. As the study progressed, it was regarded to be more ethical to treat all the affected area rather than just one part. Although this proved to be highly beneficial for the patients, it created a major deviation from the protocol. It is often found that the dressing used in a wound contributes to the maceration of the peri-wound area. Altering the dressing to support the surrounding tissues can delay healing in the wound bed; not altering the wound dressing means that there could be deterioration in the wound as the surrounding tissues deteriorate. Nevertheless, as a difference was noted in every case, it is possible that this is a reflection of results that could be taken from a larger population sample. Using patients as their own control is the only way to obtain comparative differences in wound healing. The versatility of Cavilon No Sting Barrier Film made this study very exiting and new. REFERENCE Dealey, C. (1992) Using skin wipes under adhesive tapes. Journal of Wound Care. 1. 2. 19-22 Torrance, C. (1983) Pressure Sores: Aetiology, Treatment and Prevention. London. Croome Helm. 3Health Care The use of Cavilon™ No Sting Barrier Film in the treatment of macerated tissues caused by wound exudate A case study. Mrs Roberts was a 68 year old lady who had bilateral swelling of the legs with a large ulcer on the back of her calves. The general acceptance was that this was lymphoedema with associated bilateral ulceration. Assessment of the skin showed that there was little hypertrophy, reduced pitting and enhanced natural skin folds. The swelling was large and affected both lower and upper parts of the legs. Mrs Roberts was obese and required a zimmer frame to mobilise. The ulcers had begun when she had received a knock with a shopping trolley. The left ulcer became clinically infected with staphylococcus aureus and the redness extended from the wound to her heel at the base of the wound and for about 8 cms surrounding the wound (figure 1). The ulcer was (figure 2). Erythema, caused by infection, would not leave white patches in the creases. Figure 2 Figure 1 malodorous and extremely painful. The slough in the wound was cleaned with hydrogel and covered with a foam sheet. The exudate from the wound was destroying the epithelium surrounding the wound and this can be identified by the white patches in the creases of the foot LO.0889B 10/98 The only way that the many variables in a randomised controlled trial can be “controlled”, is to use the patient as their own control and so Cavilon No Sting Barrier Film (NSBF) was applied to the right side of the peri-wound area. To comply with ethical requirements, the study stated that if the experimental half of the wound showed improvement before the control half of the wound, then Cavilon No Sting Barrier Film would then be applied to the entire area. If the experimental half of the wound showed deterioration when compared to the control side, then the study would be halted. The peri-wound area improved on the right side within 36 hours and so Cavilon NSBF was applied to the whole peri-wound. The pain in the peri-wound area reduced and Mrs Roberts said she felt “more comfortable”. Compression would have shown good results but this was refused by Mrs Roberts. On discharge, the wound was successfully being treated with a zinc bandage.