Foot Fracture, Ankle Fractures, Ankle Injuries, Foot Injuries and Disorders
Conditions
Keywords
Foot Fracture, Ankle Fractures, Ankle Injuries, Orthopaedic Devices Associated with Misadventures, Foot Injuries and Disorders
Brief summary
This is a Randomized controlled trial evaluating the effects of the use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery The trial will randomize 60 patients into an experimental group with HemaClear or Active comparator group with Pneumatic Tourniquet. The outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet
Interventions
DEVICEHemaClear
HemaClear Model A
DEVICEPneumatic Tourniquet
Pneumatic Tourniquet
Sponsors
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ankle and foot surgery
Exclusion criteria
* Infection * Tumors * Open fracture * Burns * Varicose veins * Isquemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| infection rates | after 1 week | infection rates |
| Deep vein thrombosis | after 1 week | Deep vein thrombosis (Clinical assessment and Doppler ultrasound) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local pain | after 1 week | local pain at the tourniquet site (Visual Analogue Scale) |
Countries
Brazil
Outcome results
None listed