Nail DiseasesPhase 4NCT04384679
Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
A Phase 4 study testing Hydrophilic polymer and potassium ferrate powder in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Diseases
- What is being tested?
- Hydrophilic polymer and potassium ferrate powder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Patients scheduled for any type of nail surgical procedure
- Willingness to participate in the study
- Ability to understand all instructions in the English language
Who cannot join
- Failure to have nail surgery performed
- Likely inability to comply with the study protocol or cooperate fully with the research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures
- Conditions
- Nail Diseases
- Being tested
- Hydrophilic polymer and potassium ferrate powder
- Keywords
- Nails, Nail Surgery, Hemostasis, Potassium Ferrate
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic polymer and potassium ferrate powderDevice
Application with pressure until hemostasis is achieved
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic polymer and potassium ferrate powder | Experimental | Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved Receives: Device: Hydrophilic polymer and potassium ferrate powder |
| Direct pressure with sterile gauze | No intervention | Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze
Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation
Measured: Baseline
Secondary outcomes (1)
Number of participants with at least one adverse event
Adverse events will only include those that are determined to be related to the study device
Measured: End of study (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Due to reallocation of resources, this study could not be initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail DiseasesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari R Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384679
- Sponsor's protocol ID
- 20-02021562
- Status last verified
- Aug 2022
- First submitted
- 8 May 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
- ClinicalTrials.gov ID
- NCT04384679
- Acronym / sponsor ID
- 20-02021562
- Conditions
- Nail Diseases
- Keywords
- Nails, Nail Surgery, Hemostasis, Potassium Ferrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to reallocation of resources, this study could not be initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 May 2020 (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.
The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic polymer and potassium ferrate powder | Experimental | Device: Hydrophilic polymer and potassium ferrate powderHydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved |
| Direct pressure with sterile gauze | No intervention | –Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Patients scheduled for any type of nail surgical procedure
- Willingness to participate in the study
- Ability to understand all instructions in the English language
Key exclusion criteria (2 listed)
- Failure to have nail surgery performed
- Likely inability to comply with the study protocol or cooperate fully with the research team
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 |
|---|---|---|
| Hydrophilic polymer and potassium ferrate powderApplication with pressure until hemostasis is achieved | Device | Hydrophilic polymer and potassium ferrate powder |
Primary outcome
Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze
Time frame: Baseline
Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation
1 secondary outcome
Number of participants with at least one adverse event
Time frame: End of study (28 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Shari R Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrophilic polymer and potassium ferrate powder in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Aug 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze (time frame: Baseline). 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 23 Aug 2022.