Clinical trial NCT01389089: Effective Treatment of Posttraumatic and Postoperative Edema
Official title: Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Keywords: edema reduction
ice
multi-layer compression bandage
A-V Impulse compression
ankle
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Orthofix Inc.
name: Medtronic - MITG
First posted: 2011-07-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.

Detailed description: After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.

Eligibility criteria: Inclusion criteria:

* Age 18-65 years
* Inpatients
* Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
* No walking aids before trauma
* Written informed consent
* Monotrauma
* Preoperative and/or postoperative edema
* Preoperative inclusion

  * if delay of surgery due to ankle edema
  * if fracture stable enough for temporary removal of orthesis

Exclusion criteria:

* Diabetes Mellitus
* Lymphedema
* Peripheral arterial occlusive disease (PAD)
* Decompensated heart failure or renal insufficiency
* Acute bacterial infection
* Severe osteoporosis
* Pathological fractures
* Known tumors
* Postthrombotic syndrome
* Thrombosis
* Open fractures
* Polytrauma, cerebral trauma
* Neurological deficiencies
* Diuretics
* Pregnancy
* Alcohol or drug abuse
* Psychological disorders

Primary outcomes:
measure: Ankle edema as measured with the figure-of-eight20 method
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Secondary outcomes:
measure: Pain scores measured on the Visual Analogue Scale (VAS)
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.
measure: Patient satisfaction with treatment scores measured on the Visual Analogue Scale
timeFrame: Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.
measure: Number of days until possible operation
timeFrame: Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.
measure: Number of postoperative hospitalization days
timeFrame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.
measure: Range of motion of the ankle joint and foot.
timeFrame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.
measure: Amount of daily intake of medication
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
measure: Number of adverse events as a measure of safety in each group
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.
measure: Lower limb function (Foot and ankle ability measure)
timeFrame: 12 weeks postoperative, 1 year postoperative.
measure: General Health (SF-36)
timeFrame: 12 weeks postoperative,1 year postoperative.
measure: Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale
timeFrame: 12 weeks and 1 year postoperative.
measure: Amount of volumetric lower limb edema
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
measure: Number of complains of discomfort or intolerances considering the intervention
timeFrame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital, Unfallchirurgie
Study officials:
affiliation: Luzerner Kantonsspital
name: Reto Babst, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: