Coloplast (Denmark)

Intermittent catheterization (IC) remains the standard of care for patients who are unable to empty their bladder. However, incomplete bladder emptying and urinary tract infections (UTIs) can persist, leading to complications such as recurrent infections, episodes of hospitalizations, and decreased quality of life. The Micro-hole Zone Technology (MHZT) catheter (Luja™) represents an innovative catheter design that aims to address known mechanical risk factors for UTI by minimizing flow-stops, mucosal microtrauma, and residual urine, all key contributors to infection risk. A scoping literature search was performed in PubMed and Google Scholar to identify all preclinical, clinical, and patient-reported outcome (PRO) studies evaluating the MHZT catheter (Luja). To contextualize its performance, findings were systematically compared with conventional two-eyelet catheters (CEC) across the same endpoints. The co-primary endpoints were (1) frequency of flow-stops and (2) residual urine volume at first flow-stop (RV1). Secondary endpoints included intracatheter pressure peaks, haematuria, and PRO measures related to comfort, ease of use, and perceived completeness of bladder emptying. Preclinical studies demonstrated significantly fewer flow stop with the MHZT (0% vs. up to 80% with CEC), markedly reduced residual volume at first flow-stop (mean 3.6 ± 3.9 mL vs. 38.1 ± 26.7 mL; p < 0.001) and lower intraluminal pressure peaks (− 42 ± 11 vs. − 132 ± 7 mbar; p < 0.001). From summarized data across randomized controlled trials (n > 250), catheterizations with Luja resulted in zero flow-stops and complete emptying at first flow-stop (RV1 < 10 mL) > 87% of the times compared to approximately 50% for CEC. PRO data from > 3,400 users indicated improved confidence in complete emptying, easier use and less worry for UTIs. By triangulating evidence across preclinical, clinical, and PRO studies, this review demonstrates that the MHZT/Luja catheter significantly improves bladder drainage compared with conventional designs, reducing flow-stops, residual urine, and urothelial trauma. Given that infection remains one of the most frequent IC complications, Luja offers a promising approach to lowering UTI risk factors. Enhanced user experience and confidence in complete emptying further support its potential clinical benefit.

To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, in venous leg ulcers (VLUs) after four weeks of treatment. This non-comparative, one-armed, open-labelled study included patients from two sites (clinics or community nursing caseloads) in the UK between February and May 2024. The primary endpoint was relative wound area reduction (WAR) after four weeks of treatment. Adverse events (AEs) were also assessed. In total, 50 patients with VLUs either infected or at risk of infection, and with medium-to-high levels of exudate, were included in the intention-to-treat (ITT) population. Of these, 45 patients completed the investigation on treatment and five patients discontinued the treatment. In the primary analysis, the estimated mean relative WAR after four weeks was 46.3% (95% confidence interval (CI): 36.5, 56.2%) in the full analysis set (n=49). In the sensitivity analysis based on the ITT population, it was 43.9% (95% CI: 33.1, 54.7%). In total, three AEs were found to be related to the investigational device; all were non-serious. In this study, treatment of VLUs with the investigational device showed that the mean relative WAR after four weeks of treatment was 46.3%. This reduction in wound area is comparable to the performance of other silver-containing wound dressings. In addition, the results of this clinical investigation revealed no safety concerns. Thus, the study demonstrated that the investigational device is both a safe dressing and one that performs as intended to facilitate VLU healing.

The objective of the study was to show the clinical performance and cost-effectiveness of a Silicone foam dressing with 3DFit™ Technology compared to current standard of care. This was an open-labelled, two-arm, randomised controlled multicentre study conducted from February to December 2023. One hundred and two participants with an exuding, non-infected and chronic ulcer were randomised in a 1:1 fashion and treated with either a Silicone foam with 3DFit™ Technology or standard of care (a filler combined with a secondary dressing), stratified by venous leg ulcers and diabetic foot ulcers. After a 4-week study period, wound size and total costs were evaluated. After 4 weeks of treatment, a comparable percentage in wound area reduction was observed in both treatment arms with mean and 95% confidence interval of 54.3% (37.1%; 71.5%) and 43.0% (26.5%; 59.6%) for the investigational and comparator dressing, respectively. This corresponded to a mean difference of 11.3% ([-10.22; 32.86], p = 0.299). Total mean estimated costs were significantly lower for the investigational dressing (£14.3, 95% confidence interval [£9.6; £19.0]) compared to the two-dressing regime (£21.4 [£16.9; £26.0]), corresponding to a 33% price reduction (p = 0.033) after 4 weeks of treatment. With this RCT, a conforming Silicone foam dressing with 3DFit™ Technology was shown to be clinically comparable and a cost-effective alternative to using a filler and a secondary dressing at a significantly lower cost in both venous leg ulcers and diabetic foot ulcers up to 2 cm in depth.

Abstract Background Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance peristomal skin complications, feeling unable to cope and self-isolation. Method An interventional, single-arm, multi-centre, study was undertaken in United Kingdom, to evaluate a novel digital leakage notification system for ostomy care including a Support Service (=Test Product) for 12 weeks in patients with a recent stoma formation (≤9 months). Patients completed questionnaires at baseline and after 4, 6, 8, 10 and 12 weeks, evaluating leakage episodes, Ostomy Leak Impact (tool containing three domains) and patient self-management (by PAM-13). Additionally, mental well-being (by WHO-5) and quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear- and linear mixed models. Results 92 patients (ITT population) were recruited with a mean age of 49.4-years (range 18-81 years). 80% had an ileostomy and 53% were female. After 12 weeks use of the Test Product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, P &lt;0.046) was observed. Ostomy Leak Impact scores improved across all three domains ( P &lt;0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: Δ6.6, P &lt;0.001), as did the WHO-5 well-being index (Δ8.0, P &lt;0.001). Lastly, EQ-5D-5L-profile-scores tended to improve ( P =0.075). Conclusion A new digital leakage notification system demonstrated strong improvements to patients’ stoma self-care, mental well-being, and QoL. What does this paper add to the literature? Sensor technology embedded in supporting ostomy solutions can notify users about leakage seeping underneath the baseplate and thus secure a timely change of the baseplate before effluent may reach outside the baseplate soiling clothes or bedsheets. The technology showed potential in increasing quality of life for people with a stoma.

ABSTRACT Background Living with an ostomy is often associated with costly complications. This study examined the burden of illness the first two years after ostomy creation. Methods Data from Danish national registries included all adult Danes with an ostomy created between 2002 and 2014. Results Four cohorts consisted, respectively, of 11,385 subjects with a colostomy and 4,574 with an ileostomy, of which 1,663 subjects had inflammatory bowel disease (IBD) and 1,270 colorectal cancer as cause of their ileostomy. The healthcare cost was significantly higher for cases versus matched controls for all cohorts. In the first year, the total healthcare cost per person-year was €27,962 versus €4,200 for subjects with colostomy, €29,392 versus €3,308 for subjects with ileostomy, €15,947 versus €2,216 when IBD was the underlying cause, and €32,438 versus €4,196 when it was colorectal cancer. Healthcare costs decreased in the second year but remained significantly higher than controls. Hospitalization and outpatient services were primary cost drivers, with ostomy-related complications comprising 8–16% of hospitalization expenses. Conclusion Compared to controls, subjects with an ostomy bear a significant health and financial burden attributable to ostomy-related complications, in addition to the underlying disease, emphasizing the importance of better ostomy care to enhance well-being and reduce economic strain.

Wounds that become complex and hard-to-heal are a challenge for all health care systems. Identifying and understanding the nature of these wounds is necessary to allow appropriate intervention. To present the epidemiological outcomes of the VIPES study. The prospective, observational VIPES study aimed to describe the use and investigate the performance of 2 wound dressings-a silicone foam and a gelling fiber-in the management of chronic and acute wounds in a community setting in France. Of 407 patients recorded, 285 were included in the analysis. The 184 chronic wounds included ulcers (venous/arterial/mixed, diabetic foot, and pressure) and malignant wounds. The 101 acute wounds included surgical and traumatic wounds. Of all wounds, 98.2% were exuding and 77.9% showed exudate pooling. Unhealthy wound edges and periwound skin were reported in 57.2% and 35.4% of wounds, respectively. Of all wounds, 78.6% were in treatment failure (poor exudate management or stagnant wound). The silicone foam dressing (n = 86) and the gelling fiber (n = 199) were generally used in wounds with low or moderate exudation, or moderate or high exudation, respectively. The VIPES study highlights that wounds can be complex and that community care practices in France warrant improvement. Practical and up-to-date wound management recommendations are needed.

ABSTRACT For improved wound healing, antimicrobial adhesives are one path forward. However, with the current challenge of bacterial resistance, it is essential to choose the included drug carefully. Octenidine is an obvious choice due to its broad antimicrobial efficacy and no reported bacterial resistance. In its pure form, octenidine complexes efficiently with the platinum catalyst in the silicone composition, inhibiting the targeted hydrosilylation reaction and hindering curing. This obstacle is overcome by screening octenidine with cyclodextrins in homogeneously dispersed glycerol droplets, suppressing Pt inhibition in the silicone phase. Curing efficiency is demonstrated using rheology, which shows that it is possible to incorporate one wt% of octenidine into glycerol–silicone adhesives in the presence of (2-hydroxypropyl)-β-cyclodextrin without affecting the adhesives’ mechanical properties. The interaction between octenidine and (2-hydroxypropyl)-β-cyclodextrin through an inclusion complex is confirmed by ROESY spectroscopy. Despite this screening, octenidine is still released efficiently from the glycerol–silicone adhesives upon contact with water, and the resulting antimicrobial action is subsequently demonstrated. This new technology constitutes a simple and efficient method for preparing wound care adhesives that actively inhibit the growth of four bacteria strains and one fungus.

AimsTo generate utility decrements for three attributes associated with catheterization for individuals with a spinal cord injury (SCI): the process of catheterization, the physical impact of urinary tract infections (UTIs) and worry associated with hospitalization.Materials and methodsHealth state vignettes comprising various levels of the three attributes were developed. Two cohorts of respondents, corresponding to people with SCIs and a sample broadly representative of the UK population, were presented with nine vignettes (three vignettes for the mild, moderate and severe health states in addition to a random set of six vignettes). It was assumed no or a nominal decrement was associated with the mild health state. Utility decrements were derived from analysing the data obtained from the online time trade-off (TTO). A proportion of the SCI cohort (n = 57) also completed the EQ-5D-5L questionnaire.ResultsUtility decrements were generated using statistical models for the general population (n = 358), the SCI population (n = 48) and the two populations combined (merged model, n = 406). Results from the two cohorts showed minimal differences. For the merged model, SCI status was not statistically significant. All interaction terms, excluding SCI and the severe level of the physical attribute, were not statistically significant. Compared to the mild level, the greatest utility decrement calculated was the severe level of the emotional (worry) attribute (0.09, p < .001) for the SCI population. A significant decrement of 0.02 (p < .001) was calculated for the moderate level of the emotional attribute for all models. The mean utility score for those with SCI having completed the EQ-5D-5L was 0.371.LimitationsModest sample size of respondents from the SCI population (n = 48).ConclusionsWorry associated with hospitalization had the greatest impact on patients’ health-related quality of life (HRQoL). The catheterization process, such as the lubrication and repositioning of the catheter, also impacted on patients’ HRQoL.

Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, negatively affecting their health-related quality of life (HRQoL). PSCs may also have an impact on healthcare costs for society with more visits to healthcare professionals and increased consumption of products and treatment strategies, which amplifies the need for new strategies to reduce or prevent PSCs. To evaluate the performance of an ostomy baseplate with a skin-protection technology. The target group comprised people living with a stoma with liquid faecal effluent, who struggled with PSCs. A randomized, controlled, open-labelled, cross-over trial was conducted from September 2021 to February 2022 in five different countries. Each participant tested the investigational product against a comparator product (SenSura® Mio). The Ostomy Skin Tool 2.0 was used to evaluate the peristomal skin and HRQoL was measured using the Dermatology Life Quality Index (DLQI) questionnaire. Data were analysed in mixed repeated-measures models. A total of 79 adult participants (mean age 54.5 years, female 45.6%) were included in the intention-to-treat (ITT) population. A significant reduction in PSCs (P = 0.015) and HRQoL (P = 0.035) was found for the investigational product when compared with the comparator product. Also, significantly more study participants preferred the investigational product when compared with the comparator product (P = 0.017). The investigational product, an ostomy baseplate with a skin-protective technology, reduced PSCs and improved the HRQoL of people living with a stoma with liquid faecal effluent. Consequently, the investigational product was the preferred ostomy appliance of the participants. Thus, the product investigated in this study may be a new solution to be included in everyday clinical practice to overcome leakage-induced PSCs for people living with a stoma.