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

Molnlycke Health Care

Status and phase: Completed; Phase 4

Conditions: Pressure Ulcer

Treatments: Device: Window

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438541

Window 02

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission

2. aged 18 years or over

3. have an expected total length of stay of 5 or more days

4. at high risk of PU development due to one or more of the following

   • bedfast/chairfast AND completely immobile/very limited mobility
   • category 1 PU on any pressure area skin site (see appendix G)

5. give their written, informed consent to participate

6. expected to be able to comply with follow-up schedule

Exclusion criteria

1. risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm
2. subject has category 2-4 pressure ulcer
3. subject has documented skin disease at time of enrolment, as judged by the investigator
4. known allergy/hypersensitivity to any of the components in the dressing
5. previous enroled in the present study
6. subject included in other ongoing clinical investigation at present, as judged by the investigator

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Window

Experimental group

Description:

WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.

Treatment:

Device: Window