Use of Sterile HemaClear Tourniquet Below Calf Versus Pne... | NCT04818775

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

NCT04818775

Sponsor

Hospital do Coracao

Status

Unknown status

Last Update Posted

Sep 22, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Foot Fracture
Ankle Fractures
Ankle Injuries
Foot Injuries and Disorders

Interventions

HemaClear
Pneumatic Tourniquet

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2019Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2022

Last Update Posted Date

Sep 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HemaClear	Experimental		Device: HemaClear
Pneumatic Tourniquet	Active Comparator		Device: Pneumatic Tourniquet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HemaClear	Device	HemaClear Model A	HemaClear	HemaClear Model A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
local pain	local pain at the tourniquet site (Visual Analogue Scale)	after 1 week
local pain	local pain at the tourniquet site (Visual Analogue Scale)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ankle and foot surgery

Exclusion Criteria:

Infection
Tumors
Open fracture
Burns
Varicose veins
Isquemia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurício P Barbosa, MD	Hospital do Coracao	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Coracao		São Paulo	São Paulo	04005-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D064386	Ankle Fractures
D016512	Ankle Injuries
D018409	Foot Injuries
D004194	Disease

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided