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NCT04818775 Clinical Trial

Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

Ankle Fractures Clinical Trial

— HemaClear  

Official title:
Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04818775
Other study ID # HemaClear
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 10, 2019
Est. completion date March 31, 2023

Study information
Verified date September 2022
Source Hospital do Coracao
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Ankle and foot surgery Exclusion Criteria: - Infection - Tumors - Open fracture - Burns - Varicose veins - Isquemia

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HemaClear
HemaClear Model A
• Pneumatic Tourniquet
Pneumatic Tourniquet

Locations
Country Name City State
Brazil Hospital do Coracao Sao Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary infection rates infection rates after 1 week
Primary infection rates infection rates after 3 months
Primary Deep vein thrombosis Deep vein thrombosis (Clinical assessment and Doppler ultrasound) after 1 week
Primary Deep vein thrombosis Deep vein thrombosis (Clinical assessment and Doppler ultrasound) after 3 months
Secondary local pain local pain at the tourniquet site (Visual Analogue Scale) after 1 week
Secondary local pain local pain at the tourniquet site (Visual Analogue Scale) after 3 months
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