WOUNDS INJURIESNCT05748392
3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
A study testing Wound and per-wound assessments While using Device in people with WOUNDS INJURIES, run by Solventum US LLC at 1 site in United States.
Trial summary
The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- WOUNDS INJURIES
- What is being tested?
- Wound and per-wound assessments While using Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2023
- 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
- Subject is at least 22 years old at time of consent.
- Subject OR Legal Authorized Representative is able to provide informed consent.
- Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.
Who cannot join
- Subject is pregnant prior to application of the initial dressing*
- Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing.
- Subject has been diagnosed with a malignancy in the wound.
- Subject has untreated osteomyelitis.
- Subject has an untreated systemic infection.
- Subject has active cellulitis in the peri-wound area.
Show all 16Show fewer
- Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
- Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
- Subject has had radiation directly to the wound area.
- Subject 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.
- Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.
- Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.
- Subject has non-enteric or unexplored fistula.
- Subject has a wound with any unexplored tunneling present.
- Subject has inadequate hemostasis at the wound site, as determined by the investigator.
- Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing
The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.
- Conditions
- WOUNDS INJURIES
- Being tested
- Wound and per-wound assessments While using Device
- 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.
Wound and per-wound assessments While using DeviceDevice
3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.
| Study group | Role | What they receive |
|---|---|---|
| Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments | Other | Subject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment. Receives: Device: Wound and per-wound assessments While using Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADE/SADE
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.
Measured: Up to 14 days
Secondary outcomes (3)
Total Wound Area (%)
Percent change in total wound area (%) from baseline to end-of-study.
Measured: Up to 14 days
Non-viable Tissue (%)
Change in the percentage of non-viable tissue from baseline to end-of-study.
Measured: Up to 14 days
Total Wound Volume (%)
Change in the percentage of total wound volume (%) from baseline to end-of-study.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: No longer required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WOUNDS INJURIESStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748392
- Sponsor's protocol ID
- 05-015054
- Status last verified
- Sep 2024
- First submitted
- 14 Feb 2023
- Last updated
- 1 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing
- ClinicalTrials.gov ID
- NCT05748392
- Acronym / sponsor ID
- 05-015054
- Conditions
- WOUNDS INJURIES
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 28 Feb 2023 (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 purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments | Other | Device: Wound and per-wound assessments While using DeviceSubject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 22 years old at time of consent.
- Subject OR Legal Authorized Representative is able to provide informed consent.
- Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.
Key exclusion criteria (16 listed)
- Subject is pregnant prior to application of the initial dressing*
- Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing.
- Subject has been diagnosed with a malignancy in the wound.
- Subject has untreated osteomyelitis.
- Subject has an untreated systemic infection.
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 |
|---|---|---|
| Wound and per-wound assessments While using Device3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study. | Device | Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments |
Primary outcome
ADE/SADE
Time frame: Up to 14 days
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.
3 secondary outcomes
Total Wound Area (%)
Time frame: Up to 14 days
Non-viable Tissue (%)
Time frame: Up to 14 days
Total Wound Volume (%)
Time frame: Up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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 Wound and per-wound assessments While using Device in people with WOUNDS INJURIES, run by Solventum US LLC 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 3 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Oct 2024. 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 withdrawn before enrolling participants, so there are no results.
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?
ADE/SADE (time frame: Up to 14 days). 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 Oct 2024.