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

Not Applicable

• Conditions: Foot Fracture; Ankle Injuries; Foot Injuries and Disorders; Ankle Fractures
• Interventions: Device: Pneumatic Tourniquet; Device: HemaClear

• Registration Number: NCT04818775
• Lead Sponsor: Hospital do Coracao

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Ankle and foot surgery

Exclusion Criteria

• Infection
• Tumors
• Open fracture
• Burns
• Varicose veins
• Isquemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic Tourniquet	Pneumatic Tourniquet	-
HemaClear	HemaClear	-

Primary Outcome Measures

Name	Time	Method
infection rates	after 3 months	infection rates
Deep vein thrombosis	after 3 months	Deep vein thrombosis (Clinical assessment and Doppler ultrasound)

Secondary Outcome Measures

Name	Time	Method
local pain	after 3 months	local pain at the tourniquet site (Visual Analogue Scale)

Trial Locations

Locations (1)

Hospital do Coracao; 🇧🇷 Sao Paulo, SP, Brazil