Skin WoundNP-PWD2NCT06552481
A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
A study testing NP-PWD and Wound Vac in people with Skin Wound and Soft Tissue Injuries, run by The Metis Foundation at 1 site in United States.
Trial summary
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Wound, Soft Tissue Injuries
- What is being tested?
- NP-PWD and Wound Vac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 25 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects enrolled must meet ALL the following criteria:
- Patients 18 years of age or older of either gender
- Have an open skin or soft tissue defect requiring treatment
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Active malignant disease at the study site
- Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
- On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
- Pregnant at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.
Read the detailed description
A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked to consent to participate in the study. Following consent subjects will be randomized to receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. Prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. The wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects will be followed for up to nine days post initial application. At minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. Follow up data will be gathered at each change/removal of the NP-PWD or Wound VAC. The data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the NP-PWD device for wound healing management.
- Conditions
- Skin Wound, Soft Tissue Injuries
- Being tested
- NP-PWD, Wound Vac
- Keywords
- Negative pressure therapy
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-PWDDevice
Application of NP-PWD device.
Wound VacDevice
Application of wound vac device.
| Study group | Role | What they receive |
|---|---|---|
| NP-PWD application | Experimental | Patients randomized to NP-PWD arm will have the NP-PWD device applied to their wound. Receives: Device: NP-PWD |
| Standard of Care Wound VAC application | Active comparator | Patients randomized to the standard of care arm will have the standard wound vac device applied to their wound. Receives: Device: Wound Vac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and usability of device in treatment.
The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period.
Measured: Seven to nine days post application.
Secondary outcomes (4)
Wound readiness for closure
The treating physician will use their best medical judgment to assess the wound bed using rate of epithelization, signs of infection, exposed tendon or bone and overall appearance of the wound bed to determine the wounds readiness for closure. It will be documented the number of subjects from both groups that after treatment are ready to be grafted, or are no longer requiring surgery.
Measured: Seven to nine days post application.
Incidence of colony forming units.
Colony forming units are assessed by obtaining wound swabs and analysis of presence of colony forming units.
Measured: Seven to nine days post application.
Ease of use of device by healthcare providers
At each research visit the staff will be asked if they had any questions, concerns, complaints or comments about the device or dressing. There is not a separate healthcare provider questionnaire, but any information obtained will be placed in the comments section of the source documents and the feedback will be provided to manufacture.
Measured: Seven to nine days post application.
Tolerability of the device by patient subjects
Tolerability of device by subjects will be assessed by observation of the length of time subjects were able to keep the dressing on. The subject will be asked if they have any concern or complaints about the device or dressing. Their response and if applicable the reason for removal will all be documented.
Measured: Seven to nine days post application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start16 Aug 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, The Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552481
- Sponsor's protocol ID
- NP-PWD 02
- Acronym
- NP-PWD2
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2024
- Last updated
- 14 Aug 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
- ClinicalTrials.gov ID
- NCT06552481
- Acronym / sponsor ID
- NP-PWD2 / NP-PWD 02
- Conditions
- Skin Wound, Soft Tissue Injuries
- Keywords
- Negative pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 14 Aug 2024 (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.
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.
Detailed description
A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked to consent to participate in the study. Following consent subjects will be randomized to receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. Prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. The wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects will be followed for up to nine days post initial application. At minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. Follow up data will be gathered at each change/removal of the NP-PWD or Wound VAC. The data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the NP-PWD device for wound healing management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP-PWD application | Experimental | Device: NP-PWDPatients randomized to NP-PWD arm will have the NP-PWD device applied to their wound. |
| Standard of Care Wound VAC application | Active comparator | Device: Wound VacPatients randomized to the standard of care arm will have the standard wound vac device applied to their wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older of either gender
- Have an open skin or soft tissue defect requiring treatment
Key exclusion criteria (5 listed)
- Active malignant disease at the study site
- Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
- On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
- Pregnant at enrollment
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 |
|---|---|---|
| NP-PWDApplication of NP-PWD device. | Device | NP-PWD application |
| Wound VacApplication of wound vac device. | Device | Standard of Care Wound VAC application |
Primary outcome
Feasibility and usability of device in treatment.
Time frame: Seven to nine days post application.
The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period.
4 secondary outcomes
Wound readiness for closure
Time frame: Seven to nine days post application.
Incidence of colony forming units.
Time frame: Seven to nine days post application.
Ease of use of device by healthcare providers
Time frame: Seven to nine days post application.
Tolerability of the device by patient subjects
Time frame: Seven to nine days post application.
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 14 Aug 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.
Rodney Chan, MD principal investigator
The Metis Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NP-PWD and Wound Vac in people with Skin Wound and Soft Tissue Injuries, run by The Metis Foundation 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 5 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 14 Aug 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 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?
Feasibility and usability of device in treatment. (time frame: Seven to nine days post application.). 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 14 Aug 2024.