NCT03211637

Brief Summary

Evaluate the process for implementing a wound protocol for lesion control and cost-effectiveness in the context of the Family Health Strategy in the city of Santa Cruz do Sul, Brazil.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

February 27, 2017

Last Update Submit

October 27, 2018

Conditions

Chronic Vascular Wounds in Adults

Keywords

nursing careskin lesionswound healingvaricose ulcers

Outcome Measures

Primary Outcomes (1)

  • Lesion remission by measuring the surface area of the wound

    Remission of the wound, and other clinical variables such as odor, pain, infection and presence of exudate.

    one month

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

This group comprises 6 healthcare units equipped with a Family Health Strategy, where patients are seen by coordinating nurses who have been trained to use wound dressing supplies and also on the use of the protocol.

Combination Product: Wounds Protocol

CONTROL GROUP

ACTIVE COMPARATOR

This group comprising 5 healthcare units equipped with a Family Health Strategy. Patients were seen by coordinating nurses who used techniques and supplies with which they were already familiar. They had no protocol in place.

Combination Product: Wounds Protocol

Interventions

Wounds ProtocolCOMBINATION_PRODUCT

Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.

CONTROL GROUPINTERVENTION GROUP

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting vascular (venous, arterial or mixed) ulcers for over 1 year;
  • Be available to have wounds dressed at the healthcare unit;
  • Be a patient registered with the Family Health Strategy teams.

You may not qualify if:

  • Have some condition rendering the patient unable to go to the unit, such as being bedridden or having had a lower limb amputated;
  • Having decompensated diabetes mellitus;
  • Having move away from the Family Health Strategy unit's coverage area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 27, 2017

First Posted

July 7, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share