Preoperative Treatment of Malleolar Fractures

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444468
• Other study ID #: IPC-study
• 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

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

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