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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Foot Fracture
• Foot Injuries
• Foot Injuries and Disorders
• Fractures, Bone
• Wounds and Injuries

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