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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569474
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mavilde da Luz Gonçalves Pedreira, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Phlebitis Catheter Complications Device: Transparent dressing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : May 6, 2018
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : July 6, 2020

Arm Intervention/treatment
Experimental: Dressing Group
use of sterile transparent dressing
Device: Transparent dressing
Use of sterile transparente dressing

No Intervention: Standard Group
non-sterile transparente dressing



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569474


Locations
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Brazil
Federal University of São Paulo
São Paulo, Brazil, 04024002
Universidade Federal de São Paulo
São Paulo, Brazil, 04024002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Mavilde LG Pedreira, PhD Full Professor
  Study Documents (Full-Text)

Documents provided by Mavilde da Luz Gonçalves Pedreira, Federal University of São Paulo:
Study Protocol  [PDF] July 6, 2020

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Responsible Party: Mavilde da Luz Gonçalves Pedreira, Professor; supervisor of Sandra Maria Sampaio Enes, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT04569474    
Other Study ID Numbers: 2198630
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis