Compression in Anklefracture Treatment, The CAT-study

NCT02481076 | Unknown

• 1 other identifier: H-2-2013-140
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

malleolar fractures; ORIF; compression; infection; wound dehisence

Outcome Measures

Primary Outcomes (1)

• number of participants with post-surgical wound infection, after ankle fracture operation,

  The project manager will evaluate the patient twice during the 6 weeks follow-up, in the out-patient clinic. Clinical pictures will be taken at each visit, for two senior doctors to perform a blinded evaluation according to the primary outcome. Infection is defined as Increased pain, swelling, pus secretion, redness, or warmth around the affected area. Need for antibiotics. Not all signs has to be present. The outcome is registred as "number of patients with infection"

  Within the first 6 weeks after surgery.

Secondary Outcomes (7)

• Wound dehiscence.

  Within the first 6 weeks after surgery.

• Skin necrosis.

  Within the first 6 weeks after surgery.

• Visible osteosynthesis material

  Within the first 6 weeks after surgery.

• Blisters

  Within the first 6 weeks after surgery.

• Deep venous thrombosis

  Within the first 6 weeks after surgery.

Study Arms (2)

compression therapy

EXPERIMENTAL

Intervention arm: administration of * Flowtron Hydroven boot in the Emergency Department * Coban2 Lite after surgery * Flowtron Hydroven boot after surger, before discharge

Device: Flowtron Hydroven and Coban2 Lite; Device: compression bandage

controle

OTHER

The leg is elevated on a Braun frame. This is the "old fashioned" conservative treatment to prevent swelling.

Other: Braun frame

Interventions

Flowtron Hydroven and Coban2 Lite DEVICE

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

Also known as: Flowtron Hydroven, Coban2 Lite

compression therapy

Braun frame OTHER

The leg is elevated on a Braun frame

controle

compression bandage DEVICE

application of flowtron hydroven boot and compression bandage

compression therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years.

You may not qualify if:

• Sub study 1:
• Age under 18
• Dementia
• Need for external fixation
• Known or suspected DVT or pulmonary embolism
• Patients without Danish CPR-number, or address in Denmark
• Patients who doesn´t want to participate or who are not able to give written or oral consent
• No palpable pulse in the foot in the affected leg (the posterior tibial,- or dorsal artery)
• Multi-traumatized patients and patients with fractures of more than one extremity
• Sub study 2:
• Age under 18
• Dementia
• Need for external fixation
• Multi-traumatized patients and patients with fractures of more than one extremity

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• The Research Unit, Northzealand Hospital: collaborator
• Department of Orthopedic Surgery, Northzealand Hospital: collaborator

Study Sites (1)

Unit of Orthopedic Surgery, Nordsjællands Hospital

Hillerød, Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Ankle Fractures; Infections

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Stig Sonne-Holm, Ass. Prof.

  Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, MD

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: June 25, 2015
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)