Preoperative Treatment of Malleolar Fractures

Hospital of Southern Jutland

Status: Unknown

Conditions: Preoperative Care; Comparative Study; Ankle Fractures; Intermittent Pneumatic Compression

Treatments: Device: Flowtron ACS800; Other: Bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT02444468

IPC-study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

IPC and bandage

Experimental group

Description:

Pneumatic device and bandage

Treatment:

Other: Bandage

Device: Flowtron ACS800

Bandage only

Active Comparator group

Description:

Bandage only

Treatment:

Other: Bandage