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

NCT04818775 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-09-22

No results posted yet for this study

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

Conditions

  • Foot Fracture
  • Ankle Fractures
  • Ankle Injuries
  • Foot Injuries and Disorders

Interventions

DEVICE

HemaClear

HemaClear Model A

DEVICE

Pneumatic Tourniquet

Pneumatic Tourniquet

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Maurício P Barbosa, MD · Hospital do Coracao

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818775 on ClinicalTrials.gov