Foot FractureHemaClearNCT04818775
Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
A study testing HemaClear and Pneumatic Tourniquet in people with Foot Fracture and Ankle Fractures, run by Hospital do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Fracture, Ankle Fractures, Ankle Injuries
- What is being tested?
- HemaClear and Pneumatic Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2019to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ankle and foot surgery
Who cannot join
- Infection
- Tumors
- Open fracture
- Burns
- Varicose veins
- Isquemia
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- HemaClear, Pneumatic Tourniquet
- Keywords
- Foot Fracture, Ankle Fractures, Ankle Injuries, Orthopaedic Devices Associated with Misadventures, Foot Injuries and Disorders
- Medical subject headings
- Ankle Fractures, Ankle Injuries, Foot Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemaClearDevice
Also called HemaClear Model A
HemaClear Model A
Pneumatic TourniquetDevice
Pneumatic Tourniquet
| Study group | Role | What they receive |
|---|---|---|
| HemaClear | Experimental | Not described Receives: Device: HemaClear |
| Pneumatic Tourniquet | Active comparator | Not described Receives: Device: Pneumatic Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection rates
infection rates
Measured: after 1 week
infection rates
infection rates
Measured: after 3 months
Deep vein thrombosis
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Measured: after 1 week
Deep vein thrombosis
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Measured: after 3 months
Secondary outcomes (2)
local pain
local pain at the tourniquet site (Visual Analogue Scale)
Measured: after 1 week
local pain
local pain at the tourniquet site (Visual Analogue Scale)
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Dec 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurício P Barbosa, MD, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818775
- Sponsor's protocol ID
- HemaClear
- Acronym
- HemaClear
- Status last verified
- Sep 2022
- First submitted
- 22 Mar 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
- ClinicalTrials.gov ID
- NCT04818775
- Acronym / sponsor ID
- HemaClear / HemaClear
- Keywords
- Foot Fracture, Ankle Fractures, Ankle Injuries, Orthopaedic Devices Associated with Misadventures, Foot Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HemaClear | Experimental | Device: HemaClear |
| Pneumatic Tourniquet | Active comparator | Device: Pneumatic Tourniquet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ankle and foot surgery
Key exclusion criteria (6 listed)
- Infection
- Tumors
- Open fracture
- Burns
- Varicose veins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemaClearAlso: HemaClear Model AHemaClear Model A | Device | HemaClear |
| Pneumatic TourniquetPneumatic Tourniquet | Device | Pneumatic Tourniquet |
Primary outcome
infection rates
Time frame: after 1 week
infection rates
infection rates
Time frame: after 3 months
infection rates
Deep vein thrombosis
Time frame: after 1 week
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
Deep vein thrombosis
Time frame: after 3 months
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
2 secondary outcomes
local pain
Time frame: after 1 week
local pain
Time frame: after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurício P Barbosa, MD principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemaClear and Pneumatic Tourniquet in people with Foot Fracture and Ankle Fractures, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rates (time frame: after 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.