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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: BlastX with negative pressure therapy

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Kittanning, Pennsylvania, United States, 16201
      • Armstrong County Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-arm; 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.

Device: BlastX with negative pressure therapy; Blast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound reduction in surface area	The number of subjects whose wounds reduce in surface area by more than 40% in four weeks	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	4 weeks
Incidence of device-related adverse events	The incidence of device-related adverse events (Safety and Tolerability)	4 weeks

Collaborators and Investigators

• Sponsor: SerenaGroup, Inc.
• Collaborators: Next Science TM

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 20192645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes