An open-label, prospective, randomized, noninferiority study was conducted at a large academic, Magnet-designated, Level I trauma center to compare the peripheral intravenous catheter securement-related complication rates of 2 different stabilization systems. The control stabilization system included the StatLock device with a nonwinged catheter, and the investigational stabilization system included a closed catheter system with a specially designed Tegaderm dressing. Data from 302 subjects indicated that the investigational stabilization system was noninferior or similar to the control stabilization system with respect to the overall securement-related complications. The cost of the investigational stabilization system was approximately 75% of the cost for the control stabilization system.
This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.
Medical adhesive-related skin injury is a prevalent event in the acute care setting. Preventing skin injury has the potential to reduce complications, increase patient satisfaction, and improve clinical outcomes.
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