PhlebitisPhase 1/2OTNCT04685031
Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis
A Phase 1/2 study testing Nitroglycerin ointment and Clobetasol Topical in people with Phlebitis, run by Komar University of Science and Technology.
Trial summary
The aim of this study was to determine the effect of Clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation. This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of Clobetasol, nitroglycerin, and control. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phlebitis
- What is being tested?
- Nitroglycerin ointment and Clobetasol Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 May 2021
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- must be older than 18 years old
- must be in need of hospitalization at least 72 hours
- does not state any previous allergic reaction to the ointments
- does not use any types of drug that can hurts veins (chemotherapy drugs, diazepam. amiodarone, and....)
Who cannot join
- active infection
- discharge from hospital sooner than 72 hours
- displacement of cannula before 72 hours
About this study
The aim of this study was to determine the effect of Clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation. This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of Clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
Read the detailed description
Aim: The aim of this study was to determine the effect of clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation.
Background: Today, more than 80 to 90% of hospitalized patients receive intravenous treatment during their treatment, and more than 500 million peripheral venous catheters are placed annually, although cannulation provide numerous benefits in clinical setting, but because of its invasive feature, it can end in unpleasant outcomes such as phlebitis Method: This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
- Conditions
- Phlebitis
- Being tested
- Nitroglycerin ointment, Clobetasol Topical
- Keywords
- Nitroglycerine, Clobetasol, phlebitis
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin ointmentDrug
after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
Clobetasol TopicalDrug
after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| nitroglycerin | Experimental | after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. Receives: Drug: Nitroglycerin ointment; Drug: Clobetasol Topical |
| clobetasol | Experimental | after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. Receives: Drug: Nitroglycerin ointment; Drug: Clobetasol Topical |
| routine | No intervention | routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information questionnaire
age and type of disease
Measured: 72 hours
Secondary outcomes (1)
The visual scale of phlebitis
The visual scale of phlebitis is as follows:
Grade 0: no clinical symptoms, Grade 1: pain or redness, Grade 2: pain, redness or edema at the site, unclear vein boundaries, no rope vein in touch, Grade 3: pain, redness or edema at the site, clear blood vessels, no rope vein in touch, Grade 4: the presence of pain and erythema or edema at the site, the clearness of the arteries and the rope vein in touch.
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebitisStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Komar University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yosra raziani, Komar University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685031
- Sponsor's protocol ID
- KomarUST
- Acronym
- OT
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis
- ClinicalTrials.gov ID
- NCT04685031
- Acronym / sponsor ID
- OT / KomarUST
- Conditions
- Phlebitis
- Keywords
- Nitroglycerine, Clobetasol, phlebitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Komar University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Dec 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 aim of this study was to determine the effect of Clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation. This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of Clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
Detailed description
Aim: The aim of this study was to determine the effect of clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation.
Background: Today, more than 80 to 90% of hospitalized patients receive intravenous treatment during their treatment, and more than 500 million peripheral venous catheters are placed annually, although cannulation provide numerous benefits in clinical setting, but because of its invasive feature, it can end in unpleasant outcomes such as phlebitis Method: This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nitroglycerin | Experimental | Drug: Nitroglycerin ointment, Drug: Clobetasol Topicalafter venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. |
| clobetasol | Experimental | Drug: Nitroglycerin ointment, Drug: Clobetasol Topicalafter venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. |
| routine | No intervention | –routine nursing care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- must be older than 18 years old
- must be in need of hospitalization at least 72 hours
- does not state any previous allergic reaction to the ointments
- does not use any types of drug that can hurts veins (chemotherapy drugs, diazepam. amiodarone, and....)
Key exclusion criteria (3 listed)
- active infection
- discharge from hospital sooner than 72 hours
- displacement of cannula before 72 hours
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 |
|---|---|---|
| Nitroglycerin ointmentafter venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. | Drug | clobetasol, nitroglycerin |
| Clobetasol Topicalafter venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture. | Drug | clobetasol, nitroglycerin |
Primary outcome
Demographic information questionnaire
Time frame: 72 hours
age and type of disease
1 secondary outcome
The visual scale of phlebitis
Time frame: 72hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitroglycerin ointment and Clobetasol Topical in people with Phlebitis, run by Komar University of Science and Technology.
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 3 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 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demographic information questionnaire (time frame: 72 hours). 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 28 Dec 2020.