NCT01354899

Brief Summary

The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

May 9, 2016

Completed
Last Updated

May 9, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

May 16, 2011

Results QC Date

February 25, 2016

Last Update Submit

April 5, 2016

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Erythema (No/Yes)

    Measure number of skin breakdown during from enrolment to termination.

    During 5 days

Secondary Outcomes (1)

  • Overall Experience of Use of the Dressing

    During 5 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients at ICU.

You may qualify if:

  • Provision of written informed consent
  • Braden total score ≤ 12 at enrolment
  • Male or female, ≥ 18 at enrolment
  • No skin- breakdown
  • Subject or family member is able to understand and comply with the requirements of the study, judged by the investigator

You may not qualify if:

  • Risk area dosen´t fit the dressing size
  • Documented skin disease
  • Kown allergy to any of the components in the dressing
  • Previous enroled in present study
  • Subject included in other ongoing clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

  • Jan Faergemann, Professor

    Dermatology Department Sahlgrenska University Gothenburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 9, 2016

Results First Posted

May 9, 2016

Record last verified: 2016-04

Locations

SE(1)