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The evidence on products for the prevention of radiodermatitis is limited. The primary objective was to analyse the effectiveness of the spray skin protectant ‘non-burning barrier film’ in the prevention of radiodermatitis with moist desquamation in patients with the anal canal and rectal cancer followed in nursing consultations compared to a standardised moisturiser based on Calendula officinalis and Aloe barbadensis. Single-blind randomised clinical trial. The study was performed in a hospital in Rio de Janeiro, Brazil, with 63 patients undergoing anal canal and rectal cancer treatment, randomised into one of the following two groups: an experimental group, which used a spray skin protectant and a control group, which used a moisturiser. Data were collected using an initial and subsequent evaluation form and were assessed using descriptive and inferential analyses. Participants who used the spray skin protectant had a lower chance of presenting radiodermatitis with moist desquamation and a longer time without this outcome when compared to the control group. The overall incidence of radiodermatitis was 100%, with 36.5% being severe. Furthermore, 17.5% of participants discontinued radiotherapy due to radiodermatitis. There were no differences between the groups regarding the severity of radiodermatitis and the number of patients who discontinued radiotherapy. The skin protectant was effective in preventing radiodermatitis with moist desquamation amongst patients with anal canal and rectal cancer.
Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.
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