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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211637
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao

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.

Condition or disease Intervention/treatment Phase
Chronic Vascular Wounds in Adults Combination Product: Wounds Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementing and Assessing an Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Lesion remission by measuring the surface area of the wound [ Time Frame: one month ]
    Remission of the wound, and other clinical variables such as odor, pain, infection and presence of exudate.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Daniel Demétrio Faustino da Silva, PhD, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT03211637    
Other Study ID Numbers: HNSConceicaoMP
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao:
nursing care
skin lesions
wound healing
varicose ulcers
Additional relevant MeSH terms:
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Wounds and Injuries