Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town

NCT ID: NCT03211637

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Chronic Vascular Wounds in Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CONTROL GROUP

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.

Group Type: ACTIVE_COMPARATOR

Wounds Protocol

Intervention Type: COMBINATION_PRODUCT

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

INTERVENTION GROUP

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.

Group Type: EXPERIMENTAL

Wounds Protocol

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Wounds Protocol

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role: lead

Responsible Party

Daniel Demétrio Faustino da Silva

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HNSConceicaoMP

Identifier Type: -

Identifier Source: org_study_id