An interventional study of BlastX with negative pressure therapy in Pressure Ulcer, sponsored by SerenaGroup, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by SerenaGroup, Inc. · Not applicable, Interventional, and Treatment
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.
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.
518 studies on the registry are indexed under Pressure Ulcer; 116 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 394 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →SerenaGroup, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
Wound reduction in surface area
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks
Time frame: 4 week
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
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Incidence of device-related adverse events
The incidence of device-related adverse events (Safety and Tolerability)
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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SerenaGroup, Inc.