Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial.

Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside the baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance, peristomal skin complications, feeling unable to cope, and self-isolation. An interventional, single-arm, multi-centre study was undertaken in the 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).

Psychometric validation of the Ostomy Skin Tool 2.0.

Background: Peristomal skin complications (PSCs) pose a major challenge for people living with an ostomy. To avoid severe PSCs, it is important that people with an ostomy check their peristomal skin condition on a regular basis and seek professional help when needed.

Aim: To validate a new ostomy skin tool (OST 2.

An ostomy baseplate with a skin-protection technology reduces peristomal skin complications: a randomized controlled trial (the ATTRACT study).

Background: 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.

Objectives: To evaluate the performance of an ostomy baseplate with a skin-protection technology.

Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study.

Objectives: NovoPen Echo * is a durable pediatric insulin pen incorporating half-unit dosing starting at 0.5 units and a last-dose memory function. The REMIND † (Rating the Effects of Memory function in pediatric INsulin Devices) study primarily examined the safety of this new device by collecting data on technical complaints (TCs) related to adverse reactions (ARs) during use in a clinical setting.