Wounds and InjuriesACCELERATENCT03722485
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
A study testing Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) and Collagenase Ointment in people with Wounds and Injuries and Wound Healing, run by KCI USA, Inc at 10 sites in United States.
Trial summary
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Wound Healing, Granulation Tissue
- What is being tested?
- Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) and Collagenase Ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Dec 2018to 19 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Subject:
- is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
- is ≥ 18 years of age.
- or their legally authorized representative is able to provide informed consent.
- has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:
- total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
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- < 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
- has, in the opinion of the investigator, no more than 2/3 of the 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
- The Subject:
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the periwound area.
- has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane.
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- has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
- has had radiation directly to the wound area.
- 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 bedside 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 a wound with any tunneling present.
- has inadequate hemostasis at the wound site, as determined by the investigator.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rush University Medical Center
Chicago, Illinois, 60612
University of Missouri
Columbia, Missouri, 65211
Ohio State University Medical Center
Columbus, Ohio, 43210
Northwell Health System - North Shore University Hospital
Manhasset, New York, 11030
New York University - Winthrop Hospital
Mineola, New York, 11501
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
University of Arizona
Tucson, Arizona, 85724
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
South Shore Hospital Center for Wound Healing
Weymouth, Massachusetts, 02190
About this study
Official title: Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
Read the detailed description
This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.
- Conditions
- Wounds and Injuries, Wound Healing, Granulation Tissue
- Being tested
- Negative Pressure Therapy w/ instillation and dwell (NPWTi-d), Collagenase Ointment
- 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.
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)Device
Also called V.A.C. VeraFlo Cleanse Choice, V.A.C.Ulta Therapy Unit
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
Collagenase OintmentBiological
Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) | Experimental | V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution Receives: Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) |
| Collagenase Ointment | Active comparator | Collagenase Ointment Receives: Biological: Collagenase Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
Measured: baseline and 6-9 days of treatment
Secondary outcomes (3)
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.
Measured: baseline and 6-9 days of treatment
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Measured: baseline and 6-9 days of treatment
Physician Assessment of Need for Wound Debridement
Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
Measured: 6-9 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start12 Dec 2018
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: Enrollment challenges and business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wounds and 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722485
- Sponsor's protocol ID
- KCI.CLEANSE.CHOICE.2017.02
- Acronym
- ACCELERATE
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2018
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
- ClinicalTrials.gov ID
- NCT03722485
- Acronym / sponsor ID
- ACCELERATE / KCI.CLEANSE.CHOICE.2017.02
- Conditions
- Wounds and Injuries, Wound Healing, Granulation Tissue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges and business reasons.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
Detailed description
This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) | Experimental | Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution |
| Collagenase Ointment | Active comparator | Biological: Collagenase OintmentCollagenase Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
- is ≥ 18 years of age.
- or their legally authorized representative is able to provide informed consent.
- has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:
- has, in the opinion of the investigator, no more than 2/3 of the 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.
Key exclusion criteria (14 listed)
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the periwound area.
- has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), 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 |
|---|---|---|
| Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)Also: V.A.C. VeraFlo Cleanse Choice, V.A.C.Ulta Therapy UnitNegative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. | Device | Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) |
| Collagenase OintmentCollagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. | Biological | Collagenase Ointment |
Primary outcome
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
Time frame: baseline and 6-9 days of treatment
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
3 secondary outcomes
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
Time frame: baseline and 6-9 days of treatment
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
Time frame: baseline and 6-9 days of treatment
Physician Assessment of Need for Wound Debridement
Time frame: 6-9 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) and Collagenase Ointment in people with Wounds and Injuries and Wound Healing, run by KCI USA, Inc at 10 sites 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 9 inclusion and 14 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 16 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 10 sites 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. (time frame: baseline and 6-9 days of treatment). 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 16 Oct 2024.