A Chitosan-Coated Chamomile Microparticles Formulation to Prevent Radiodermatitis in Breast: A Double-blinded, Controlled, Randomized, Phase II Clinical Trial.

PURPOSE: The aim was to evaluate the effect of a topical formulation containing chitosan-coated Chamomilla recutita (L.) rauschert microparticles regarding the incidence, grade, and days for the appearance of radiodermatitis (RD) in women with breast cancer. METHODS: A double-blinded, controlled, randomized, phase II clinical trial developed with women diagnosed with breast cancer who will receive radiation therapy. The participants were randomly divided into 2 groups: control and treatment. They were followed up until the end of the treatment or the appearance of grade III RD. RESULTS: Fifty-four women were included in the study. There is no significant difference between the groups in the incidence (88.9% vs. 88.9%, P=1.0) or time to develop any grade of RD (3 days of difference, P=0.300). A significant reduction was observed in the incidence (P=0.03) and in the time to appearance (7 d of difference, P=0.01) grade 2 or >RD. In the follow-up evaluation (15 d after the end of treatment), the Chamomile group presented a superior skin recovery than the control group (P=0.0343). High-intensity local symptoms as pain, and pruritus were significantly reduced in the Chamomile group. CONCLUSIONS: Although no effect was observed with chamomile to reduce any grade of RD, it was effective to reduce grade 2 or >toxicity, to improve skin recovery and to diminish high-intensity local symptoms. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC): RBR-9hnftg, April 29, 2019.

Concept Analysis and Content Validation of Risk of Injury to the Urinary Tract: Nursing Diagnosis.

PURPOSE: To elaborate, propose, and validate risk for urinary tract injury as a nursing diagnosis. METHODS: Methodology was divided into three phases: analysis of the concept of urinary tract injury, elaboration of the diagnosis, and validation by a group of specialists. FINDINGS: Diagnosis label, definition, and inclusion in taxonomy were validated. In 15 risk factors proposed, 12 were validated. CONCLUSIONS: Risk of urinary tract injury was validated as a nursing diagnosis to contemplate the vulnerability of patients using urinary catheters. IMPLICATIONS FOR NURSING PRACTICE: Identification of these risk factors contributes to the elaboration of care plans to improve quality of care.