NCT01438541

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2016

Completed
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

September 13, 2011

Results QC Date

May 13, 2016

Last Update Submit

August 22, 2016

Conditions

Pressure Ulcer

Keywords

No skin breakdownPreventionprotection of the skin

Outcome Measures

Primary Outcomes (1)

  • Erythema ( No/Yes)

    Total improvement of erythema

    14 days

Secondary Outcomes (2)

  • Overall Experience of Use of the Dressing

    14 days

  • Evaluate the Dressing Shape

    14 days

Study Arms (1)

Window

EXPERIMENTAL

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.

Device: Window

Interventions

WindowDEVICE

Dressing

Window

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute vascular, surgical, orthopaedic, medical or care of the elderly admission
  • aged 18 years or over
  • have an expected total length of stay of 5 or more days
  • 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)
  • give their written, informed consent to participate
  • expected to be able to comply with follow-up schedule

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospitals Birmingham NHS

Birmingham, B152TH, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

The Mid Yourkshire Hospitals NHS Trust

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Tina Kjellén
Organization
Molnlycke Health Care AB
tina.kjellen@molnlycke.com
+46317223098

Study Officials

  • Carol Dealey, BSc

    University Hospital Birmingham NHS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

October 14, 2016

Results First Posted

October 14, 2016

Record last verified: 2016-08

Locations

GB(3)