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

Implementing and Assessing an Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town

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.

Study Overview

• Status: Completed
• Conditions: Chronic Vascular Wounds in Adults
• Intervention / Treatment: Combination product: Wounds Protocol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Wounds Protocol; Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.
Active Comparator: 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.	Combination product: Wounds Protocol; Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Nossa Senhora da Conceicao

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 27, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: wound healing; skin lesions; nursing care; varicose ulcers
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HNSConceicaoMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No