NCT04818775

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

3.1 years

First QC Date

March 22, 2021

Last Update Submit

September 21, 2022

Conditions

Foot FractureAnkle FracturesAnkle InjuriesFoot Injuries and Disorders

Keywords

Foot FractureAnkle FracturesAnkle InjuriesOrthopaedic Devices Associated with MisadventuresFoot Injuries and Disorders

Outcome Measures

Primary Outcomes (4)

  • infection rates

    infection rates

    after 1 week

  • infection rates

    infection rates

    after 3 months

  • Deep vein thrombosis

    Deep vein thrombosis (Clinical assessment and Doppler ultrasound)

    after 1 week

  • Deep vein thrombosis

    Deep vein thrombosis (Clinical assessment and Doppler ultrasound)

    after 3 months

Secondary Outcomes (2)

  • local pain

    after 1 week

  • local pain

    after 3 months

Study Arms (2)

HemaClear

EXPERIMENTAL
Device: HemaClear

Pneumatic Tourniquet

ACTIVE COMPARATOR
Device: Pneumatic Tourniquet

Interventions

HemaClearDEVICE

HemaClear Model A

Also known as: HemaClear Model A
HemaClear
Pneumatic TourniquetDEVICE

Pneumatic Tourniquet

Pneumatic Tourniquet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ankle and foot surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

Ankle FracturesAnkle InjuriesFoot InjuriesDisease

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maurício P Barbosa, MD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 26, 2021

Study Start

December 10, 2019

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

BR(1)