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Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy (BlastVac-001)

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BlastX with negative pressure therapy
Sponsored by
SerenaGroup, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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).
  2. A signed and dated informed consent form.
  3. Subject is able to comply with instructions and scheduled visits.
  4. Ulcer surface area >2cm2 and < 100cm2.
  5. The patient is a candidate for negative pressure wound therapy.

Exclusion Criteria:

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.

Sites / Locations

  • Armstrong County Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Wound reduction in surface area
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks

Secondary Outcome Measures

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
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
Reduction in wound-related pain
The number of subjects who report a reduction in wound-related pain as measured on a Numerical Rating Scale
Incidence of device-related adverse events
The incidence of device-related adverse events (Safety and Tolerability)

Full Information

First Posted
January 28, 2020
Last Updated
March 11, 2022
Sponsor
SerenaGroup, Inc.
Collaborators
Next Science TM
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1. Study Identification

Unique Protocol Identification Number
NCT04265170
Brief Title
Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy
Acronym
BlastVac-001
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SerenaGroup, Inc.
Collaborators
Next Science TM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BlastX with negative pressure therapy
Intervention Description
Blast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy.
Primary Outcome Measure Information:
Title
Wound reduction in surface area
Description
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Wounds have a reduction in bacterial load
Description
The number of subjects whose wounds have a reduction in bacterial load to below 10^4 as measured by fluorescence imaging
Time Frame
4 weeks
Title
Wounds have a reduction in inflammatory proteases
Description
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
Time Frame
4 weeks
Title
Reduction in wound-related pain
Description
The number of subjects who report a reduction in wound-related pain as measured on a Numerical Rating Scale
Time Frame
4 weeks
Title
Incidence of device-related adverse events
Description
The incidence of device-related adverse events (Safety and Tolerability)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Armstrong County Memorial Hospital
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy

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