NCT04569474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

April 2, 2018

Last Update Submit

September 25, 2020

Conditions

PhlebitisCatheter Complications

Outcome Measures

Primary Outcomes (1)

  • Phlebitis

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

    Unitl day 7 of catheter placement and study participation

Study Arms (2)

Dressing Group

EXPERIMENTAL

use of sterile transparent dressing

Device: Transparent dressing

Standard Group

NO INTERVENTION

non-sterile transparente dressing

Interventions

Transparent dressingDEVICE

Use of sterile transparente dressing

Dressing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Sepsis
  • Skin lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal University of São Paulo

São Paulo, 04024002, Brazil

Location

Universidade Federal de São Paulo

São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Study Officials

  • Mavilde LG Pedreira, PhD

    Full Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; supervisor of Sandra Maria Sampaio Enes

Study Record Dates

First Submitted

April 2, 2018

First Posted

September 29, 2020

Study Start

May 6, 2018

Primary Completion

September 10, 2019

Study Completion

July 6, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)