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

NCT ID: NCT04818775

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Foot Fracture Ankle Fractures Ankle Injuries Foot Injuries and Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HemaClear

Group Type EXPERIMENTAL

HemaClear

Intervention Type DEVICE

HemaClear Model A

Pneumatic Tourniquet

Group Type ACTIVE_COMPARATOR

Pneumatic Tourniquet

Intervention Type DEVICE

Pneumatic Tourniquet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HemaClear

HemaClear Model A

Intervention Type DEVICE

Pneumatic Tourniquet

Pneumatic Tourniquet

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HemaClear Model A

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ankle and foot surgery

Exclusion Criteria

* Infection
* Tumors
* Open fracture
* Burns
* Varicose veins
* Isquemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maurício P Barbosa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital do Coracao

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HemaClear

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ankle Fracture Tourniquet Utilization
NCT06863688 ENROLLING_BY_INVITATION NA
Fixation of Medial Malleolar Fractures .
NCT07148375 ACTIVE_NOT_RECRUITING NA
Pre-hospital Tourniquet in Extremity Injury
NCT04216225 ENROLLING_BY_INVITATION