Effective Treatment of Posttraumatic and Postoperative Edema

NCT01389089 | Completed DMC

• 1 other identifier: 616
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema

Keywords

edema reduction; ice; multi-layer compression bandage; A-V Impulse compression; ankle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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.

• 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.

• Number of days until possible operation

  Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.

• Number of postoperative hospitalization days

  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.

  Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.

Study Arms (3)

Control group

SHAM COMPARATOR

The Control group received ice gel packs and elevation to reduce edema.

Behavioral: ice gel pack

Multi-layer compression bandage

EXPERIMENTAL

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

A-V Impulse compression

ACTIVE COMPARATOR

An A-V Impulse compression device was used to reduce edema.

Device: A-V Impulse compression

Interventions

ice gel pack BEHAVIORAL

ice gel pack combined with elevation

Control group

Multi-layer compression bandage OTHER

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).

Also known as: Artiflex, Comprilan

Multi-layer compression bandage

A-V Impulse compression DEVICE

A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.

Also known as: A-V intermittent Impulse compression device., AVI

A-V Impulse compression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Orthofix Inc.: collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Luzerner Kantonsspital, Unfallchirurgie

Lucerne, 6000 16, Switzerland

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reto Babst, Prof.Dr.med.

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Reto Babst, Senior Consultant Orthopedic Trauma

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 7, 2011
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

CH (1)