A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities.

Multicenter, phase-4, randomized, comparative-efficacy study in patients with VLUs or DFUs comparing for noninferiority the percentage change in target ulcer dimensions (area, depth, and volume) a single-use negative pressure wound therapy (s-NPWT) system versus traditional NPWT (t-NPWT) over a 12-week treatment period or up to confirmed healing. Baseline values were taken at the randomization visit. Randomized by wound type and size, 164 patients with non-infected DFUs and VLUs were included. The ITT population was composed of 161 patients (101 with VLUs, 60 with DFUs) and 115 patients completed follow-up (64 in the s-NPWT group and 51 in the t-NPWT group) (PP population). The average age for all patients was 61.5 years, 36.6% were women, and treatment groups were statistically similar at baseline. Primary endpoint analyses on wound area reduction demonstrated statistically significant reduction in favor of s-NPWT (p = 0.003) for the PP population and for the ITT population (p < 0.001). Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT. Faster wound closure was observed with s-NPWT (Cox Proportional Hazards ratio (0.493 (0.273, 0.891); p = 0.019) in the ITT population. Wound closure occurred in 45% of patients in the s-NPWT group vs. 22.2% of patients in the t-NPWT group (p = 0.002). Median estimate of the time to wound closure was 77 days for s-NPWT. No estimate could be provided for t-NPWT due to the low number of patients achieving wound closure. Device-related AEs were more frequent in the t-NPWT group (41 AEs from 29 patients) than in the s-NPWT group (16 AEs from 12 patients). The s-NPWT system met noninferiority and achieved statistical superiority vs. t-NPWT in terms of wound progression toward healing over the treatment period. When NPWT is being considered for the management of challenging VLUs and DFUs, s-NPWT should be considered a first choice over other types of NPWT.

TIME CDST: an updated tool to address the current challenges in wound care.

Despite the understanding that wounds are a common problem affecting the individual, the health service and society as a whole, there continues to be a lack of a systematic, structured, evidence-based approach to wound management. The TIME principle was first published in 2003, 1 and has since been integrated by many into clinical practice and research. However, this tool has been criticised for its tendency to focus mainly on the wound rather than on the wider issues that the patient is presenting with. At an expert meeting held in London in 2018, this conundrum was addressed and the TIME clinical decision support tool (CDST) was elaborated upon. This article introduces the TIME CDST, explains why it is required and describes how its use is likely to benefit patients, clinicians and health-service organisations. It also explores the framework in detail, and shows why this simple and accessible framework is robust enough to facilitate consistency in the delivery of wound care and better patient outcomes. Finally, it outlines the next steps for the rollout, use and evaluation of the impact of the TIME CDST.

Evaluation of a skin barrier cream for managing IAD in elderly patients using high-frequency ultrasound.

Incontinence-associated dermatitis (IAD) is a defined pathological entity and presents a significant burden for patients and health-care systems. The main objective of this evaluation was to test the efficacy and safety of a skin barrier cream in the management of uncomplicated IAD in elderly patients. Ten incontinent patients with mobility problems that presented with signs of IAD were included in the evaluation. The evaluation took place during a 2-week period. The product's efficacy was objectively evaluated in each patient with high-frequency ultrasound scans taken from the irritated skin compared with an ultrasound scan taken from normal adjacent (control) skin. Data analysis showed a statistical significance in favour of the capacity of the product to help reduce inflammatory signs. Photographic follow-up allowed correlation of ultrasound findings and clinical signs. The product was effective in treating the skin irritation and preventing further skin breakdown. There were no adverse events during the evaluation.