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NCT00285961 Clinical Trial

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Wounds and Injuries Clinical Trial

Official title:
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285961
Other study ID # 2003/364
Secondary ID
Status Completed
Phase N/A
First received February 1, 2006
Last updated May 11, 2009
Est. completion date April 2004

Study information
Verified date February 2009
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 11 Years
Eligibility Inclusion Criteria:

- Fractures of the wrist, forearm, elbow, ankle, foot

- Distortions of the wrist, elbow, ankle

- Wounds without tendon injuries

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Cork splint materials (instead of plaster splint)

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functionality
Primary Added value
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