Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
Primary Purpose
Chronic Vascular Wounds in Adults
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wounds Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Vascular Wounds in Adults focused on measuring nursing care, skin lesions, wound healing, varicose ulcers
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
INTERVENTION GROUP
CONTROL GROUP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03211637
First Posted
February 27, 2017
Last Updated
October 27, 2018
Sponsor
Hospital Nossa Senhora da Conceicao
1. Study Identification
Unique Protocol Identification Number
NCT03211637
Brief Title
Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
Official Title
Implementing and Assessing an Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nossa Senhora da Conceicao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Vascular Wounds in Adults
Keywords
nursing care, skin lesions, wound healing, varicose ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INTERVENTION GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Wounds Protocol
Intervention Description
Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.
Primary Outcome Measure Information:
Title
Lesion remission by measuring the surface area of the wound
Description
Remission of the wound, and other clinical variables such as odor, pain, infection and presence of exudate.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
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