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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438541
• Other study ID #: Window 02
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: July 2, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Device:
• Window
Dressing

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS	Birmingham
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	The Mid Yourkshire Hospitals NHS Trust	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No skin breakdown during the study period, by observation of the skin.	To evaluate the performance of a thin self-adherent dressing in preventing the development of category 2 and above pressure ulcers in vulnerable subjects with a high risk of skin breakdown.	14 days	No
Secondary	Conformability of a dressing	To investigate the conformability of a thin self-adherent dressing coated with a soft silicone layer in this subject population.How the dressing reacts when it comes to stay on ability and skin status according to nurse evaluation.	14 days	No
Secondary	Performance of a dressing	Occular observation of the performance of a thin self-adherent dressing coated with a soft silicone layer in this subject population.	14 days	No