Pressure UlcerBlastVac-001NCT04265170
Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy
A study testing BlastX with negative pressure therapy in people with Pressure Ulcer, run by SerenaGroup, Inc. at 1 site in United States.
Trial summary
A Multi-center, Prospective Clinical Trial Evaluating the Combination of BlastX and Negative Pressure Wound Therapy (VAC).To evaluate the 4-week healing trajectory/wound area reduction with BlastX/VAC as compared with historical pre-study 4-week healing trajectory data and data from the US Wound Registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- BlastX with negative pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 1 Feb 2022
- 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
- Adult patients with a Full Thickness Pressure Ulcer Stage 3 through Stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (Sacral, trochanteric, ischial or posterior heel).
- A signed and dated informed consent form.
- Subject is able to comply with instructions and scheduled visits.
- Ulcer surface area >2cm2 and < 100cm2.
- The patient is a candidate for negative pressure wound therapy.
Who cannot join
- 1.Subject or caregiver is unable to manage VAC®device OR the patient cannot return for VAC dressing changes OR the patient does not qualify for home health visits. 2.Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- 3.Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- 4.The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
- 5.Known contraindications to VAC® or Blast-X® 6.Known allergies to any of the Blast-X®components 7.Concurrent participation in another clinical trial that involves an investigation drug or device that would interfere with this study.
- 8.Subject is pregnant or breast feeding. 9.Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- 10.Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
- 11.Mini-nutritional assessment Malnutrition Indication score <17. 12.Patient does not have adequate 4-week historical data on comparison in change of wound measurements, photos, costs and supplies used.
Trial locations and contacts
1 site in 1 country.
United States1 site
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
About this study
Official title: A Multicentre Pilot Clinical Trial, Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy (NPWT, VAC®) in Validating 4-Week Wound Area Reduction and Reducing Bacterial Bioburden in Chronic Pressure Ulcers
A Multi-center, Prospective Clinical Trial Evaluating the Combination of BlastX and Negative Pressure Wound Therapy (VAC).To evaluate the 4-week healing trajectory/wound area reduction with BlastX/VAC as compared with historical pre-study 4-week healing trajectory data and data from the US Wound Registry.
Read the detailed description
The study is a prospective, clinical trial designed to evaluate the combination of BlastX™ and VAC® in facilitating healing and reduction in bio-burden in pressure ulcers. After consenting, the ulcers of eligible subjects are treated with BlastX. After a 5 minute dwell time the wound VAC® is applied as per manufacturers guidelines. The subjects return to the center three times per week for dressing changes and application of BlastX. The duration of the trial is four weeks. Subjects undergo study procedures (biopsy for quantitative tissue culture, photography, fluorescence imaging and swabbing for protease testing) on a weekly basis. The standard of care for pressure ulcers will be continued including debridement, off-loading, and nutritional supplementation when appropriate.
- Conditions
- Pressure Ulcer
- Being tested
- BlastX with negative pressure therapy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlastX with negative pressure therapyDevice
Blast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Eligible patients are treated with BlastX and VAC. The subjects return to the center three times per week for dressing changes and application of BlastX. The duration of the trial is four weeks and 8 weeks for larger wounds (2 subjects only). Subjects undergo study procedures (biopsy for quantitative tissue culture, photography, fluorescence imaging and swabbing for protease testing) on a weekly basis. The standard of care for pressure ulcers will be continued including debridement, off-loading, and nutritional supplementation when appropriate. Receives: Device: BlastX with negative pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound reduction in surface area
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks
Measured: 4 week
Secondary outcomes (4)
Wounds have a reduction in bacterial load
The number of subjects whose wounds have a reduction in bacterial load to below 10^4 as measured by fluorescence imaging
Measured: 4 weeks
Wounds have a reduction in inflammatory proteases
The number of subjects whose wounds have a reduction in inflammatory proteases (matrixmetalloproteases 2,8 and 9 and Human Neutrophil elastase as measured with a standardized point-of-care test
Measured: 4 weeks
Reduction in wound-related pain
The number of subjects who report a reduction in wound-related pain as measured on a Numerical Rating Scale
Measured: 4 weeks
Incidence of device-related adverse events
The incidence of device-related adverse events (Safety and Tolerability)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start24 Oct 2019
- Primary completion31 Jul 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Next Science TM
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265170
- Sponsor's protocol ID
- 20192645
- Acronym
- BlastVac-001
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Pilot Clinical Trial, Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy (NPWT, VAC®) in Validating 4-Week Wound Area Reduction and Reducing Bacterial Bioburden in Chronic Pressure Ulcers
- ClinicalTrials.gov ID
- NCT04265170
- Acronym / sponsor ID
- BlastVac-001 / 20192645
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Next Science TM
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 11 Feb 2020 (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.
A Multi-center, Prospective Clinical Trial Evaluating the Combination of BlastX and Negative Pressure Wound Therapy (VAC).To evaluate the 4-week healing trajectory/wound area reduction with BlastX/VAC as compared with historical pre-study 4-week healing trajectory data and data from the US Wound Registry.
Detailed description
The study is a prospective, clinical trial designed to evaluate the combination of BlastX™ and VAC® in facilitating healing and reduction in bio-burden in pressure ulcers. After consenting, the ulcers of eligible subjects are treated with BlastX. After a 5 minute dwell time the wound VAC® is applied as per manufacturers guidelines. The subjects return to the center three times per week for dressing changes and application of BlastX. The duration of the trial is four weeks. Subjects undergo study procedures (biopsy for quantitative tissue culture, photography, fluorescence imaging and swabbing for protease testing) on a weekly basis. The standard of care for pressure ulcers will be continued including debridement, off-loading, and nutritional supplementation when appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: BlastX with negative pressure therapyEligible patients are treated with BlastX and VAC. The subjects return to the center three times per week for dressing changes and application of BlastX. The duration of the trial is four weeks and 8 weeks for larger wounds (2 subjects only). Subjects undergo study procedures (biopsy for quantitative tissue culture, photography, fluorescence imaging and swabbing for protease testing) on a weekly basis. The standard of care for pressure ulcers will be continued including debridement, off-loading, and nutritional supplementation when appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with a Full Thickness Pressure Ulcer Stage 3 through Stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (Sacral, trochanteric, ischial or posterior heel).
- A signed and dated informed consent form.
- Subject is able to comply with instructions and scheduled visits.
- Ulcer surface area >2cm2 and < 100cm2.
- The patient is a candidate for negative pressure wound therapy.
Key exclusion criteria (7 listed)
- 1.Subject or caregiver is unable to manage VAC®device OR the patient cannot return for VAC dressing changes OR the patient does not qualify for home health visits. 2.Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- 3.Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- 4.The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
- 5.Known contraindications to VAC® or Blast-X® 6.Known allergies to any of the Blast-X®components 7.Concurrent participation in another clinical trial that involves an investigation drug or device that would interfere with this study.
- 8.Subject is pregnant or breast feeding. 9.Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
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 |
|---|---|---|
| BlastX with negative pressure therapyBlast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy. | Device | Single-arm |
Primary outcome
Wound reduction in surface area
Time frame: 4 week
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks
4 secondary outcomes
Wounds have a reduction in bacterial load
Time frame: 4 weeks
Wounds have a reduction in inflammatory proteases
Time frame: 4 weeks
Reduction in wound-related pain
Time frame: 4 weeks
Incidence of device-related adverse events
Time frame: 4 weeks
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 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 BlastX with negative pressure therapy in people with Pressure Ulcer, run by SerenaGroup, Inc. 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 7 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 Mar 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 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?
Wound reduction in surface area (time frame: 4 week). 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 Mar 2022.