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Effective Treatment of Posttraumatic and Postoperative Edema

This study has been completed.
Sponsor:
Collaborators:
Orthofix Inc.
Covidien
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT01389089
First received: June 23, 2011
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Edema
Other: ice gel pack
Other: Multi-layer compression bandage
Device: A-V Impulse compression
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Ankle edema as measured with the figure-of-eight20 method [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pain scores measured on the Visual Analogue Scale (VAS) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction with treatment scores measured on the Visual Analogue Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative. ] [ Designated as safety issue: No ]
    Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.

  • Amount of daily intake of medication [ Time Frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. ] [ Designated as safety issue: No ]
    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).

  • Number of adverse events as a measure of safety in each group [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    Adverse events were defined as:

    bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.


  • Lower limb function (Foot and ankle ability measure) [ Time Frame: 12 weeks postoperative, 1 year postoperative. ] [ Designated as safety issue: No ]
    Questionnaire, self-assessed by the patient. To assess function and participation.

  • General Health (SF-36) [ Time Frame: 12 weeks postoperative,1 year postoperative. ] [ Designated as safety issue: No ]
    Generic assessment of the health status with the SF-36.

  • Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale [ Time Frame: 12 weeks and 1 year postoperative. ] [ Designated as safety issue: No ]
    Patients had to record on the VAS on how satisfied they were with the overall outcome.

  • Amount of volumetric lower limb edema [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. ] [ Designated as safety issue: Yes ]
    Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).


Enrollment: 64
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
The Control group received ice gel packs and elevation to reduce edema.
Other: ice gel pack
ice gel pack combined with elevation
Other Names:
  • cold
  • ice
  • cold packs
Experimental: Multi-layer compression bandage
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
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).
Other Names:
  • Artiflex
  • Comprilan
Experimental: A-V Impulse compression
An A-V Impulse compression device was used to reduce edema.
Device: A-V Impulse compression
A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
Other Names:
  • A-V intermittent Impulse compression device.
  • AVI

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389089

Locations
Switzerland
Luzerner Kantonsspital, Unfallchirurgie
Luzern, Switzerland, 6000 16
Sponsors and Collaborators
Luzerner Kantonsspital
Orthofix Inc.
Covidien
Investigators
Principal Investigator: Reto Babst, Prof.Dr.med. Luzerner Kantonsspital
  More Information

No publications provided

Responsible Party: Prof.Dr.med. Reto Babst, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT01389089     History of Changes
Other Study ID Numbers: 616
Study First Received: June 23, 2011
Last Updated: July 6, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by Luzerner Kantonsspital:
edema reduction
ice
multi-layer compression bandage
A-V Impulse compression
ankle

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014