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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02444468
Other study ID # IPC-study
Secondary ID
Status Recruiting
Phase N/A
First received April 28, 2015
Last updated August 17, 2016
Start date March 2015
Est. completion date April 2018

Study information

Verified date August 2016
Source Hospital of Southern Jutland
Contact Jesper O Schønnemann, Dr
Phone +4579976170
Email jesper.ougaard.schoennemann1@rsyd.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date April 2018
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Flowtron ACS800
Flowtron ACS800 and bandage
Other:
Bandage
Bandage only

Locations

Country Name City State
Denmark Jesper O. Schønnemann Åbenrå

Sponsors (1)

Lead Sponsor Collaborator
Hospital of Southern Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from diagnosis-to-surgery 5 days No
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