Wounds and InjuryPhase 4NCT04753723
The Use of a Platform Wound Device for Reducing Infection
A Phase 4 study testing Gentamycin with Platform Wound Device in people with Wounds and Injury and Burn Wound, run by The Metis Foundation at 4 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds and Injury, Burn Wound, Infection Wound
- What is being tested?
- Gentamycin with Platform Wound Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Feb 2021to 25 May 2022
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 and age less than or equal to 85
- Open wound up to 500cm2 in area with evidence of infection
- Exposure of deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone
Who cannot join
- Pregnancy
- Prisoner
- Active malignancy, steroid use, or immunosuppressive therapy
- Open fracture intimately involved with wound
- Underlying osteomyelitis
- Hardware or prosthetic exposure within wound
- Exposure of major named vessels or nerves
- Known allergy to gentamicin or other aminoglycosides
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baptist Medical Center
San Antonio, Texas, 78205
North East Baptist Hospital
San Antonio, Texas, 78217
Mission Trail Baptist Hospital
San Antonio, Texas, 78235
North Central Baptist Hospital
San Antonio, Texas, 78258
About this study
Official title: The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial
This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound, non-inferior to the current standard of care. This treatment will reduce or rapidly eradicate infection.
Read the detailed description
This is a prospective, randomized, controlled clinical trial comparing the use of a platform wound device as compared to standard of care to prevent or eliminate infection in torso and extremity wounds. Patients 18-85 years of age admitted for treatment of open wound(s) will be screened for inclusion criteria and asked to consent to participate in the randomized study. The first 10 patients will be treated with the PWD + gentamicin and will serve as a safety subset. Baseline measurement of serum antibiotic concentraion will be taken prior to PWD placement and one day after. Following the safety subset, 50 patients will be randomized to standard of care or to a single application of the PWD + gentamicin. Baseline assessments will be completed on day 0, including screening, pre-procedure wound evaluation, imaging, assessments, and specimen collection. Follow-up assessments will be completed and data gathered at days 1,2,3 and 4. All data collected of the study participants will be used to evaluate the PWD delivery of antibiotic.
- Conditions
- Wounds and Injury, Burn Wound, Infection Wound
- Being tested
- Gentamycin with Platform Wound Device
- Medical subject headings
- Wounds and Injuries, Burns, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamycin with Platform Wound DeviceCombination product
Treatment of wounds with gentamycin and covered with platform wound device.
| Study group | Role | What they receive |
|---|---|---|
| Platform wound device with antibiotic | Experimental | Antibiotic cream will be applied to study wounds and then dressed with the platform wound device. Receives: Combination Product: Gentamycin with Platform Wound Device |
| Standard of Care | No intervention | Study wounds will be treated per the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of treatment
Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.
Measured: 48 to 96 hours
Tolerability of treatment
To demonstrate that patients are able to tolerate application of the PWD with 0.1% gentamicin cream application. Tolerability will be assessed by documentation of adverse events.
Measured: 48 to 96 hours
Secondary outcomes (1)
Effectiveness of wound swabs
To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results.
Measured: 48 to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start8 Feb 2021
- Primary completion19 Nov 2021
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753723
- Sponsor's protocol ID
- PWD-1
- Status last verified
- Oct 2022
- First submitted
- 8 Feb 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT04753723
- Acronym / sponsor ID
- PWD-1
- Conditions
- Wounds and Injury, Burn Wound, Infection Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 15 Feb 2021 (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 evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound, non-inferior to the current standard of care. This treatment will reduce or rapidly eradicate infection.
Detailed description
This is a prospective, randomized, controlled clinical trial comparing the use of a platform wound device as compared to standard of care to prevent or eliminate infection in torso and extremity wounds. Patients 18-85 years of age admitted for treatment of open wound(s) will be screened for inclusion criteria and asked to consent to participate in the randomized study. The first 10 patients will be treated with the PWD + gentamicin and will serve as a safety subset. Baseline measurement of serum antibiotic concentraion will be taken prior to PWD placement and one day after. Following the safety subset, 50 patients will be randomized to standard of care or to a single application of the PWD + gentamicin. Baseline assessments will be completed on day 0, including screening, pre-procedure wound evaluation, imaging, assessments, and specimen collection. Follow-up assessments will be completed and data gathered at days 1,2,3 and 4. All data collected of the study participants will be used to evaluate the PWD delivery of antibiotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platform wound device with antibiotic | Experimental | Combination Product: Gentamycin with Platform Wound DeviceAntibiotic cream will be applied to study wounds and then dressed with the platform wound device. |
| Standard of Care | No intervention | –Study wounds will be treated per the standard of care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater or equal to 18 and age less than or equal to 85
- Open wound up to 500cm2 in area with evidence of infection
- Exposure of deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone
Key exclusion criteria (8 listed)
- Pregnancy
- Prisoner
- Active malignancy, steroid use, or immunosuppressive therapy
- Open fracture intimately involved with wound
- Underlying osteomyelitis
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 |
|---|---|---|
| Gentamycin with Platform Wound DeviceTreatment of wounds with gentamycin and covered with platform wound device. | Combination product | Platform wound device with antibiotic |
Primary outcome
Feasibility of treatment
Time frame: 48 to 96 hours
Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.
Tolerability of treatment
Time frame: 48 to 96 hours
To demonstrate that patients are able to tolerate application of the PWD with 0.1% gentamicin cream application. Tolerability will be assessed by documentation of adverse events.
1 secondary outcome
Effectiveness of wound swabs
Time frame: 48 to 96 hours
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 Oct 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamycin with Platform Wound Device in people with Wounds and Injury and Burn Wound, run by The Metis Foundation at 4 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 3 inclusion and 8 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of treatment (time frame: 48 to 96 hours). The study lists 2 primary outcomes in all. 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 Oct 2022.