A single-blind, randomised controlled trial of StrataXRT® - A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer.

AIM: Investigate the effects of StrataXRT® versus 10% Glycerine (Sorbolene cream) for preventing and managing radiation dermatitis in patients with head and neck cancer receiving radical radiotherapy (≥50 Gy) with or without chemotherapy or biotherapy. METHODS: A single-blind, randomised controlled, superiority trial was conducted. Patients either received StrataXRT® or Sorbolene (usual care). Skin toxicity, pain, itching and skin-related quality of life scores were collected from baseline, and up to four weeks post-treatment. RESULTS: A total of 197 patients were randomised into the study. Skin toxicity was dependent on the treatment group with StrataXRT® patients experiencing lower mean skin toxicity at the end of the radiation treatment (P = 0.002). At the end of treatment, the StrataXRT® arm had a lower percentage of grade 2 (80%) and grade 3 (28%) skin toxicity compared to the sorbolene arm (91% and 45% respectively). After adjustment for Cetuximab, the StrataXRT® arm had a 12% lower risk of experiencing grade 2 skin toxicity (RRR = 0.876, 95% CI: 0.778-0.987, P = 0.031); and a 36% lower risk of experiencing grade 3 skin toxicity (RRR = 0.648, 95% CI: 0.442-0.947, P = 0.025). Cox regression analysis showed that patients receiving StrataXRT® had a 41.0% and 49.4% reduced risks of developing grade 2 and 3 skin toxicity respectively throughout treatment compared to the Sorbolene arm. There were no differences between groups in patient-reported outcomes. No treatment interruptions and study product related adverse events were reported in either arm. CONCLUSION: StrataXRT® is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity. TRIAL REGISTRATION: ACTRN12616000511437.

Do nurse navigators bring about fewer patient hospitalisations?

PURPOSE: Nurse navigators (NNs) coordinate patient care, improve care quality and potentially reduce healthcare resource use. The purpose of this paper is to undertake an evaluation of hospitalisation outcomes in a new NN programme in Queensland, Australia. DESIGN/METHODOLOGY/APPROACH: A matched case-control study was performed. Patients under the care of the NNs were randomly selected ( n=100) and were matched to historical ( n=300) and concurrent ( n=300) comparison groups. The key outcomes of interest were the number and types of hospitalisations, length of hospital stay and number of intensive care unit days. Generalised linear and two-part models were used to determine significant differences in resources across groups. FINDINGS: The control and NN groups were well matched on socio-economic characteristics, however, groups differed by major disease type and number/type of comorbidities. NN patients had high healthcare needs with 53 per cent having two comorbidities. In adjusted analyses, compared with the control groups, NN patients showed higher proportions of preventable hospitalisations over 12 months, similar days in intensive care and a smaller proportion had overnight stays in hospital. However, the NN patients had significantly more hospitalisations (mean: 6.0 for NN cases, 3.4 for historical group and 3.2 for concurrent group); and emergency visits. RESEARCH LIMITATIONS/IMPLICATIONS: As many factors will affect hospitalisation rates beyond whether patients receive NN care, further research and longer follow-up is required. ORIGINALITY/VALUE: A matched case-control study provides a reasonable but insufficient design to compare the NN and non-NN exposed patient outcomes.