WoundNCT04026334
Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
A study testing V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline in people with Wound and Wound Heal, run by 3M at 1 site in United States.
Trial summary
The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Wound, Wound Heal, Wounds and Injuries
- What is being tested?
- V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 28 Aug 2020
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is anticipated to be hospitalized for the duration of treatment.
- is ≥22 years of age or their legally authorized representative is able to provide informed consent.
- has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
- has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
- has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
Who cannot join
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the peri wound area.
- has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
- has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
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- has had radiation directly to the wound.
- has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
- has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
- is participating in another interventional clinical trial for the duration of the study.
- has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
- has inadequate hemostasis at the wound site, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
About this study
Official title: Evaluation of Hydromechanical Cleansing Using Normal Saline With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWT-d to Promote Increased Healthy Wound Bed Tissue
The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.
- Conditions
- Wound, Wound Heal, Wounds and Injuries, Granulation Tissue, Negative-pressure Wound Therapy
- Being tested
- V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal SalineDevice
-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline | Experimental | Not described Receives: Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue
Measured: Baseline to Day 6-9
Secondary outcomes (3)
Percent change in total wound volume (cm3)
Measured: Baseline to Day 6-9
Percent change in total wound area (cm2)
Measured: Baseline to Day 6-9
Physician assessment of the need for surgical debridement
This will be a subjective assessment made by the Investigator of Yes or No
Measured: Day 6-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start25 Jul 2019
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Why it stopped: Insufficient subject accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026334
- Sponsor's protocol ID
- KCI.CLEANSE.CHOICE.2019.01
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2019
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hydromechanical Cleansing Using Normal Saline With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWT-d to Promote Increased Healthy Wound Bed Tissue
- ClinicalTrials.gov ID
- NCT04026334
- Acronym / sponsor ID
- KCI.CLEANSE.CHOICE.2019.01
- Conditions
- Wound, Wound Heal, Wounds and Injuries, Granulation Tissue, Negative-pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient subject accrual rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 19 Jul 2019 (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.
The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline | Experimental | Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- is anticipated to be hospitalized for the duration of treatment.
- is ≥22 years of age or their legally authorized representative is able to provide informed consent.
- has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
- has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
- has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
Key exclusion criteria (12 listed)
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the peri wound area.
- has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
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 |
|---|---|---|
| V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy | Device | V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline |
Primary outcome
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue
Time frame: Baseline to Day 6-9
3 secondary outcomes
Percent change in total wound volume (cm3)
Time frame: Baseline to Day 6-9
Percent change in total wound area (cm2)
Time frame: Baseline to Day 6-9
Physician assessment of the need for surgical debridement
Time frame: Day 6-9
Results and safety
The study was stopped early (reason given: Insufficient subject accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline in people with Wound and Wound Heal, run by 3M at 1 site in United States.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Insufficient subject accrual rate). Results are not available in the source record.
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?
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue (time frame: Baseline to Day 6-9). 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 1 Aug 2022.