Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2015-03-31
2018-04-30
Brief Summary
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The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.
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Detailed Description
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This can lead to severe oedema which can compromise the ability to perform surgery due to blister formation or the inability to close the skin after surgery. Studies have shown that the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from diagnosis to surgery as well as reduce length of hospital stay.
Purpose of the study is in a randomized study to investigate whether patients requiring surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC than patients not using IPC.
All patients age 18 or above admitted to our hospital with malleolar fractures (AO type 44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of surgery(time of incision) will be the primary outcome. Patients will be seen in a postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IPC and bandage
Pneumatic device and bandage
Flowtron ACS800
Flowtron ACS800 and bandage
Bandage
Bandage only
Bandage only
Bandage only
Bandage
Bandage only
Interventions
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Flowtron ACS800
Flowtron ACS800 and bandage
Bandage
Bandage only
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known or suspected acute DVT or flebit.
* Severe decompensated heart failure.
* Pulmonary embolism.
* Acute skin conditions as dermatitis, infected wounds or recent skintransplant.
* Open fracture.
* Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.
* Pregnancy.
18 Years
ALL
No
Sponsors
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Hospital of Southern Jutland
OTHER
Responsible Party
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Principal Investigators
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Jesper O Schønnemann, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital southern Jutland
Locations
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Jesper O. Schønnemann
Aabenraa, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IPC-study
Identifier Type: -
Identifier Source: org_study_id
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