Peripheral IV Dressing and Phlebitis in Patients From Amazon

NCT ID: NCT04569474

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-06
• Study Completion Date: 2020-07-06

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.

Conditions

Phlebitis; Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dressing Group

use of sterile transparent dressing

Group Type: EXPERIMENTAL

Transparent dressing

Intervention Type: DEVICE

Use of sterile transparente dressing

Standard Group

non-sterile transparente dressing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transparent dressing

Use of sterile transparente dressing

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mavilde da Luz Gonçalves Pedreira

Professor; supervisor of Sandra Maria Sampaio Enes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mavilde LG Pedreira, PhD

Role: PRINCIPAL_INVESTIGATOR

Full Professor

Locations

Federal University of São Paulo

São Paulo, , Brazil

Universidade Federal de São Paulo

São Paulo, , Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2198630

Identifier Type: -

Identifier Source: org_study_id