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Preoperative Treatment of Malleolar Fractures

A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02444468
Enrollment
96
Registered
2015-05-14
Start date
2015-03-31
Completion date
2018-04-30
Last updated
2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Intermittent Pneumatic Compression, Comparative Study, Preoperative Care

Brief summary

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.

Detailed description

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.

Interventions

DEVICEFlowtron ACS800

Flowtron ACS800 and bandage

OTHERBandage

Bandage only

Sponsors

Hospital of Southern Jutland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Malleolar fracture requiring surgery.

Exclusion criteria

* Severe arteriosclerosis. * 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.

Design outcomes

Primary

MeasureTime frame
Time from diagnosis-to-surgery5 days

Countries

Denmark

Contacts

Primary ContactJesper O Schønnemann, Dr
jesper.ougaard.schoennemann1@rsyd.dk+4579976170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026