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

Primary Purpose

Foot Fracture, Ankle Fractures, Ankle Injuries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HemaClear
Pneumatic Tourniquet
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Fracture focused on measuring Foot Fracture, Ankle Fractures, Ankle Injuries, Orthopaedic Devices Associated with Misadventures, Foot Injuries and Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ankle and foot surgery

Exclusion Criteria:

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

Sites / Locations

  • Hospital do Coracao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HemaClear

Pneumatic Tourniquet

Arm Description

Outcomes

Primary Outcome Measures

infection rates
infection rates
infection rates
infection rates
Deep vein thrombosis
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Deep vein thrombosis
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)

Secondary Outcome Measures

local pain
local pain at the tourniquet site (Visual Analogue Scale)
local pain
local pain at the tourniquet site (Visual Analogue Scale)

Full Information

First Posted
March 22, 2021
Last Updated
September 21, 2022
Sponsor
Hospital do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT04818775
Brief Title
Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
Acronym
HemaClear
Official Title
Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Fracture, Ankle Fractures, Ankle Injuries, Foot Injuries and Disorders
Keywords
Foot Fracture, Ankle Fractures, Ankle Injuries, Orthopaedic Devices Associated with Misadventures, Foot Injuries and Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HemaClear
Arm Type
Experimental
Arm Title
Pneumatic Tourniquet
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
HemaClear
Other Intervention Name(s)
HemaClear Model A
Intervention Description
HemaClear Model A
Intervention Type
Device
Intervention Name(s)
Pneumatic Tourniquet
Intervention Description
Pneumatic Tourniquet
Primary Outcome Measure Information:
Title
infection rates
Description
infection rates
Time Frame
after 1 week
Title
infection rates
Description
infection rates
Time Frame
after 3 months
Title
Deep vein thrombosis
Description
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Time Frame
after 1 week
Title
Deep vein thrombosis
Description
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
local pain
Description
local pain at the tourniquet site (Visual Analogue Scale)
Time Frame
after 1 week
Title
local pain
Description
local pain at the tourniquet site (Visual Analogue Scale)
Time Frame
after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ankle and foot surgery Exclusion Criteria: Infection Tumors Open fracture Burns Varicose veins Isquemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurício P Barbosa, MD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Coracao
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04005-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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