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Compression in Anklefracture Treatment, The CAT-study

NCT02481076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2016-08-16

No results posted yet for this study

Summary

The aim of this project is to find out if compression treatment can lower the incidens of surgical wound complications, such as infection and wound rupture, in patients with ankle fractures. The compression regime consists of a two-layered compression stocking applied after surgery and a massage boot applied both before and after surgery.

The largest part of the study is the clinical trial, with which we aim to prove the hypothesis:

\* That the compression regime reduces wound infections from 10-40% to 5% on patients with a broken ankle (Either one side of the ankle, two or three sides (including the posterior part of the ankle))

Conditions

  • Ankle Fractures

Interventions

DEVICE

Flowtron Hydroven and Coban2 Lite

The patient in the intervention group will use both compression boot and compression bandage, as described in intervention arm

OTHER

Braun frame

The leg is elevated on a Braun frame

DEVICE

compression bandage

application of flowtron hydroven boot and compression bandage

Sponsors & Collaborators

  • The Research Unit, Northzealand Hospital

    collaborator UNKNOWN

  • Department of Orthopedic Surgery, Northzealand Hospital

    collaborator UNKNOWN

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Stig Sonne-Holm, Ass. Prof. · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-12-31
Completion
2017-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481076 on ClinicalTrials.gov