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Peripheral IV Dressing and Phlebitis in Patients From Amazon (IVDRESAMAZON)

Primary Purpose

Phlebitis, Catheter Complications

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transparent dressing
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phlebitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • Sepsis
  • Skin lesions

Sites / Locations

  • Federal University of São Paulo
  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dressing Group

Standard Group

Arm Description

use of sterile transparent dressing

non-sterile transparente dressing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 2, 2018
Last Updated
September 25, 2020
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04569474
Brief Title
Peripheral IV Dressing and Phlebitis in Patients From Amazon
Acronym
IVDRESAMAZON
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2018 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phlebitis, Catheter Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dressing Group
Arm Type
Experimental
Arm Description
use of sterile transparent dressing
Arm Title
Standard Group
Arm Type
No Intervention
Arm Description
non-sterile transparente dressing
Intervention Type
Device
Intervention Name(s)
Transparent dressing
Intervention Description
Use of sterile transparente dressing
Primary Outcome Measure Information:
Title
Phlebitis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Sepsis Skin lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mavilde LG Pedreira, PhD
Organizational Affiliation
Full Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04024002
Country
Brazil
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04024002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peripheral IV Dressing and Phlebitis in Patients From Amazon

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