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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
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 27, 2017
    Last Updated
    October 27, 2018
    Sponsor
    Hospital Nossa Senhora da Conceicao
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    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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