NCT04265170

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-24
• Primary completion: 2021-07-31
• Completion: 2022-02-01
• First posted: 2020-02-11
• Last updated: 2022-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study