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A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures
This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling. 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.
Malleolar fractures are often complicated by tissue swelling due to soft tissue injury, haemorrhage and secondary inflammation. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jesper O. Schønnemann
Aabenraa, Denmark
Start Date
March 1, 2015
Primary Completion Date
April 1, 2017
Completion Date
April 1, 2018
Last Updated
August 18, 2016
96
ESTIMATED participants
Flowtron ACS800
DEVICE
Bandage
OTHER
Lead Sponsor
Hospital of Southern Jutland
NCT06085586
NCT06709365
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06518265