Chronic Vascular Wounds in AdultsNCT03211637
Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
A study testing Wounds Protocol in people with Chronic Vascular Wounds in Adults, run by Hospital Nossa Senhora da Conceicao.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Chronic Vascular Wounds in Adults
- What is being tested?
- Wounds Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Chronic Vascular Wounds in Adults
- Being tested
- Wounds Protocol
- Keywords
- nursing care, skin lesions, wound healing, varicose ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wounds ProtocolCombination product
Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | 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. Receives: Combination Product: Wounds Protocol |
| CONTROL GROUP | Active comparator | 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. Receives: Combination Product: Wounds Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startJun 2016
- Primary completionDec 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Vascular Wounds in AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211637
- Sponsor's protocol ID
- HNSConceicaoMP
- Status last verified
- Oct 2018
- First submitted
- 27 Feb 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Assessing an Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
- ClinicalTrials.gov ID
- NCT03211637
- Acronym / sponsor ID
- HNSConceicaoMP
- Conditions
- Chronic Vascular Wounds in Adults
- Keywords
- nursing care, skin lesions, wound healing, varicose ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Combination Product: Wounds ProtocolThis 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. |
| CONTROL GROUP | Active comparator | Combination Product: Wounds ProtocolThis 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wounds ProtocolNurses who have been trained to use wound dressing supplies and also on the use of the protocol. | Combination product | CONTROL GROUP, INTERVENTION GROUP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Wounds Protocol in people with Chronic Vascular Wounds in Adults, run by Hospital Nossa Senhora da Conceicao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion remission by measuring the surface area of the wound (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.