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

June 23, 2011
July 6, 2011
January 2007
January 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01389089 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Effective Treatment of Posttraumatic and Postoperative Edema
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Edema
  • Other: ice gel pack
    ice gel pack combined with elevation
    Other Names:
    • cold
    • ice
    • cold packs
  • 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
  • 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
  • No Intervention: Control group
    The Control group received ice gel packs and elevation to reduce edema.
    Intervention: Other: ice gel pack
  • 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.
    Intervention: Other: Multi-layer compression bandage
  • Experimental: A-V Impulse compression
    An A-V Impulse compression device was used to reduce edema.
    Intervention: Device: A-V Impulse compression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2010
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01389089
616
Yes
Prof.Dr.med. Reto Babst, Luzerner Kantonsspital
Luzerner Kantonsspital
  • Orthofix Inc.
  • Covidien
Principal Investigator: Reto Babst, Prof.Dr.med. Luzerner Kantonsspital
Luzerner Kantonsspital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP