Edema
Conditions
Keywords
edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle
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.
Interventions
BEHAVIORALice gel pack
ice gel pack combined with elevation
OTHERMulti-layer compression bandage
Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).
DEVICEA-V Impulse compression
A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
Sponsors
Orthofix Inc.
Medtronic - MITG
Luzerner Kantonsspital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle edema as measured with the figure-of-eight20 method | 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. | The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with treatment scores measured on the Visual Analogue Scale | 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. | Visual Analogue Scales were used to assess patient satisfaction with the assigned treatment. The patients had to record their satisfaction with the treatment before surgery and after surgery. |
| Number of days until possible operation | Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days. | The surgeon daily had to assess whether the patient was ready for operation or not. The wrinkling test served as a criteria for decision making. Accordingly the number of days until possible operation was recorded. |
| Number of postoperative hospitalization days | Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. | Postoperatively the physiotherapist each day had to record whether or not the patient was ready for discharge. Discharge criteria: 1. patient is able to walk 20 meters and one flight of stairs with crutches. 2. the wound is dry and not irritated. Accordingly, the number of days of postoperative hospitalization until discharge criteria were reached was recorded. |
| Range of motion of the ankle joint and foot. | Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative. | Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer. |
| Amount of daily intake of medication | Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. | The intake of daily pain medication was recorded for the instay period (Dafalgan, Novalgin, opiates). Furthermore, the patient file was screened for any Nonsteroidal anti-inflammatory drugs (not allowed). |
| Pain scores measured on the Visual Analogue Scale (VAS) | 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. | Visual Analogue Scales were used to assess a daily pain score reflecting strongest and average pain perceived during the previous 24 hours, night pain and pain frequency. |
| Lower limb function (Foot and ankle ability measure) | 12 weeks postoperative, 1 year postoperative. | Questionnaire, self-assessed by the patient. To assess function and participation. |
| General Health (SF-36) | 12 weeks postoperative,1 year postoperative. | Generic assessment of the health status with the SF-36. |
| Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale | 12 weeks and 1 year postoperative. | Patients had to record on the VAS on how satisfied they were with the overall outcome. |
| Amount of volumetric lower limb edema | 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. | Measurements of circumference of the lower limb were used to calculate lower limb volume. The circumferences of the lower limb were measured in increments of 4 cm from ankle level until below the knee joint. |
| Number of complains of discomfort or intolerances considering the intervention | Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. | Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances). |
| Number of adverse events as a measure of safety in each group | 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. | Adverse events were defined as: bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism. |
Countries
Switzerland
Outcome results
None listed