PhlebitisIVDRESAMAZONNCT04569474
Peripheral IV Dressing and Phlebitis in Patients From Amazon
A study testing Transparent dressing in people with Phlebitis and Catheter Complications, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
Pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phlebitis, Catheter Complications
- What is being tested?
- Transparent dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesBrazil
- Study dates
- 6 May 2018to 6 Jul 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IV access for more 48 hours obtained in the studied wards.
- IV access 20 and 22 G.
- without confusion or agitation
- Aged more or equal 18 years
Who cannot join
- Sepsis
- Skin lesions
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal University of São Paulo
São Paulo, 04024002
Universidade Federal de São Paulo
São Paulo, 04024002
About this study
Official title: Efficacy of Sterile Dressing in the Prevention of of Peripheral Intravenous Catheters Associated Phlebitis in Patients From the Western Brazilian Amazon: Pragmatic, Randomized, Blinded and Controlled Trail
Pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon.
Read the detailed description
Peripheral venous catheterization is the most commonly performed invasive procedure in healthcare. Care practices and the use of technologies may influence the results of the use peripheral intravenous catheters (PIC), contributing to the reduction of complications and adverse events. Phlebitis is characterized as one of the most serious complication related to the use of PIC and this study has as hypothesis to analyze if the occurrence of phlebitis associated with PIC is influenced by the use of sterile dressing. Objectives: To verify the effect of using sterile dressing and sterile adhesive tape compared to non-sterile adhesive tape in PIC on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon. Methods: Pragmatic, randomized, controlled and single-blinded clinical study conducted in Rio Branco, Acre. The sample was calculated in 330 patients, aged 18 years or older and who met the inclusion criteria. Data collection took place between June 2018 and September 2019, after approval of ethical merit. To identify the type of sterile transparent dressing to be studied, was carried out an implementation study with a final sample of 71 patients, focusing analysis from the perspective of the patient, professional and clinics. The patients of the clinical study were randomly allocated to one of the study groups: Experimental group (sterile transparent dressing) or Standard Group (non-sterile adhesive tape). Phlebitis was diagnosed by the bedside nurse, according to presence and severity. If present, the nurse removed the CIP and an external evaluator was called to perform a diagnose of phlebitis with blindness regarding the intervention. Variables related to patient characterization, intravenous therapy, peripheral venipuncture, reasons for withdrawal and length of PIC stay, reasons for removal and length of coverage, and associated complications were investigated. For the statistical analysis, Chi-square, Fisher's Exact, student t test, and Mann-Whitney U tests were used. The multiple analysis was performed using the logistic regression model to estimate the Relative Risk (RR) and the Kaplan-Meier model, Cox regression, for survival analysis. RR calculation for 95% Confidence Interval (IC) was applied to estimate the degree of association between variables. In all tests, the significance level of 5% was considered.
- Conditions
- Phlebitis, Catheter Complications
- Being tested
- Transparent dressing
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparent dressingDevice
Use of sterile transparente dressing
| Study group | Role | What they receive |
|---|---|---|
| Dressing Group | Experimental | use of sterile transparent dressing Receives: Device: Transparent dressing |
| Standard Group | No intervention | non-sterile transparente dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phlebitis
Vein inflamation measure by Scale Grades from Infusion Nursing Society rating from zero (absence) to 4 (severe phlebitis)
Measured: Unitl day 7 of catheter placement and study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start6 May 2018
- Primary completion10 Sep 2019
- Study completion6 Jul 2020
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mavilde da Luz Gonçalves Pedreira, Federal University of São Paulo
- Investigators
- Mavilde LG Pedreira, PhD, Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569474
- Sponsor's protocol ID
- 2198630
- Acronym
- IVDRESAMAZON
- Status last verified
- Sep 2020
- First submitted
- 2 Apr 2018
- Last updated
- 29 Sep 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sterile Dressing in the Prevention of of Peripheral Intravenous Catheters Associated Phlebitis in Patients From the Western Brazilian Amazon: Pragmatic, Randomized, Blinded and Controlled Trail
- ClinicalTrials.gov ID
- NCT04569474
- Acronym / sponsor ID
- IVDRESAMAZON / 2198630
- Conditions
- Phlebitis, Catheter Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 6 May 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 29 Sep 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.
Pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon.
Detailed description
Peripheral venous catheterization is the most commonly performed invasive procedure in healthcare. Care practices and the use of technologies may influence the results of the use peripheral intravenous catheters (PIC), contributing to the reduction of complications and adverse events. Phlebitis is characterized as one of the most serious complication related to the use of PIC and this study has as hypothesis to analyze if the occurrence of phlebitis associated with PIC is influenced by the use of sterile dressing. Objectives: To verify the effect of using sterile dressing and sterile adhesive tape compared to non-sterile adhesive tape in PIC on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon. Methods: Pragmatic, randomized, controlled and single-blinded clinical study conducted in Rio Branco, Acre. The sample was calculated in 330 patients, aged 18 years or older and who met the inclusion criteria. Data collection took place between June 2018 and September 2019, after approval of ethical merit. To identify the type of sterile transparent dressing to be studied, was carried out an implementation study with a final sample of 71 patients, focusing analysis from the perspective of the patient, professional and clinics. The patients of the clinical study were randomly allocated to one of the study groups: Experimental group (sterile transparent dressing) or Standard Group (non-sterile adhesive tape). Phlebitis was diagnosed by the bedside nurse, according to presence and severity. If present, the nurse removed the CIP and an external evaluator was called to perform a diagnose of phlebitis with blindness regarding the intervention. Variables related to patient characterization, intravenous therapy, peripheral venipuncture, reasons for withdrawal and length of PIC stay, reasons for removal and length of coverage, and associated complications were investigated. For the statistical analysis, Chi-square, Fisher's Exact, student t test, and Mann-Whitney U tests were used. The multiple analysis was performed using the logistic regression model to estimate the Relative Risk (RR) and the Kaplan-Meier model, Cox regression, for survival analysis. RR calculation for 95% Confidence Interval (IC) was applied to estimate the degree of association between variables. In all tests, the significance level of 5% was considered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dressing Group | Experimental | Device: Transparent dressinguse of sterile transparent dressing |
| Standard Group | No intervention | –non-sterile transparente dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IV access for more 48 hours obtained in the studied wards.
- IV access 20 and 22 G.
- without confusion or agitation
- Aged more or equal 18 years
Key exclusion criteria (2 listed)
- Sepsis
- Skin lesions
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 |
|---|---|---|
| Transparent dressingUse of sterile transparente dressing | Device | Dressing Group |
Primary outcome
Phlebitis
Time frame: Unitl day 7 of catheter placement and study participation
Vein inflamation measure by Scale Grades from Infusion Nursing Society rating from zero (absence) to 4 (severe phlebitis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Mavilde LG Pedreira, PhD principal investigator
Full Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transparent dressing in people with Phlebitis and Catheter Complications, run by Federal University of São Paulo at 2 sites 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 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: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phlebitis (time frame: Unitl day 7 of catheter placement and study participation). 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 29 Sep 2020.