NCT01438541

A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration

A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation. The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Window	Dressing

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2011-09-22
• Last updated: 2016-10-14
• Results posted: 2016-10-14

Locations

3 sites across 1 country: United Kingdom