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CompletedNCT04569474IVDRESAMAZONUpdated Sep 29, 2020

Peripheral IV Dressing and Phlebitis in Patients From Amazon

An interventional study of Transparent dressing in Phlebitis and Catheter Complications, sponsored by Federal University of São Paulo. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Phlebitis
  • Catheter Complications

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Sepsis
  • Skin lesions
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    Dressing Group

    use of sterile transparent dressing

    Device: Transparent dressing

  • No intervention
    Standard Group

    non-sterile transparente dressing

Interventions

  • DeviceTransparent dressing

    Use of sterile transparente dressing

05

What researchers measure

Primary outcomes

  1. Phlebitis

    Vein inflamation measure by Scale Grades from Infusion Nursing Society rating from zero (absence) to 4 (severe phlebitis)

    Time frame: Unitl day 7 of catheter placement and study participation

06

Study locations

2 sites
  • Federal University of São Paulo
    São Paulo, 04024002, Brazil
  • Universidade Federal de São Paulo
    São Paulo, 04024002, Brazil
07

References and documents

Study documents

  • Study protocol · Jul 6, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04569474
Lead sponsor
Federal University of São Paulo
Responsible party
Mavilde da Luz Gonçalves Pedreira (Professor; supervisor of Sandra Maria Sampaio Enes, Federal University of São Paulo) — Principal investigator
First posted
Sep 29, 2020
Start date
May 6, 2018
Primary completion
Sep 10, 2019
Completion
Jul 6, 2020
Last update
Sep 29, 2020

Study contacts

Mavilde LG Pedreira, PhD
principal investigator · Full Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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