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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao

ClinicalTrials.gov Identifier:

NCT03211637

First received: February 27, 2017

Last updated: July 5, 2017

Last verified: July 2017

History of Changes

Purpose

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	Intervention
Chronic Vascular Wounds in Adults	Combination Product: Wounds Protocol


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao:

Primary Outcome Measures:

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.


Enrollment:	20
Actual Study Start Date:	June 2016
Estimated Study Completion Date:	June 2018
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	60 Years to 90 Years (Adult, Senior)
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Daniel Demétrio Faustino da Silva, PhD, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:	NCT03211637 History of Changes
Other Study ID Numbers:	HNSConceicaoMP
Study First Received:	February 27, 2017
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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:


Wounds and Injuries

ClinicalTrials.gov processed this record on July 11, 2017

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