Effective Treatment of Posttraumatic and Postoperative Edema

Study Overview
=================
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.

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

Conditions
-----------------
Edema

Intervention / Treatment
-----------------
* Behavioral: ice gel pack
* Other: Multi-layer compression bandage
* Device: A-V Impulse compression


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>The Control group received ice gel packs and elevation to reduce edema. | Behavioral: ice gel pack<br>* ice gel pack combined with elevation<br>|
| Experimental: Multi-layer compression bandage<br>A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated. | Other: Multi-layer compression bandage<br>* 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).<br>* Other names: Comprilan;|
| Active Comparator: A-V Impulse compression<br>An A-V Impulse compression device was used to reduce edema. | Device: A-V Impulse compression<br>* A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.<br>* Other names: AVI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle edema as measured with the figure-of-eight20 method | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores measured on the Visual Analogue Scale (VAS) | 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. | 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. | 
| Patient satisfaction with treatment scores measured on the Visual Analogue Scale | 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. | 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. | 
| Number of days until possible operation | 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. | Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days. | 
| Number of postoperative hospitalization 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. | Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. | 
| Range of motion of the ankle joint and foot. | Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer. | Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative. | 
| Amount of daily intake of medication | 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). | Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. | 
| Number of adverse events as a measure of safety in each group | Adverse events were defined as: bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism. | 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. | 
| Lower limb function (Foot and ankle ability measure) | Questionnaire, self-assessed by the patient. To assess function and participation. | 12 weeks postoperative, 1 year postoperative. | 
| General Health (SF-36) | Generic assessment of the health status with the SF-36. | 12 weeks postoperative,1 year postoperative. | 
| Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale | Patients had to record on the VAS on how satisfied they were with the overall outcome. | 12 weeks and 1 year postoperative. | 
| Amount of volumetric lower limb edema | 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. | 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. | 
| Number of complains of discomfort or intolerances considering the intervention | Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances). | Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle