Chronic Wound
Conditions
Keywords
biofilm, EPS matrix, antimicrobial
Brief summary
This is a 12-week, single-site, open-label prospective study in adult with a chronic wound diagnosis. Subjects will be randomized in equal numbers to either the control treatment arm, antimicrobial control treatment arm, or Next Science treatment arm and will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks.
Detailed description
This is a 12-week, single-site, open-label prospective study in adult subjects ages 18 years of age and older with a chronic wound diagnosis. There will be 15 completed subjects with up to 18 enrolled. Subjects will be randomized in equal numbers to control group (Mepilex Foam dressing); antimicrobial control group (Mepilex Ag Foam dressing); or Next Science group (TorrentX irrigation, BlastX application, and Mepilex foam dressing). Subjects will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks. For the Next Science arm, TorrentX will be used during in-office debridement whereas BlastX will be applied once during the in-office visit and then mid-week with dressing change. DNA and plate count analysis will be taken at maximum of 5 time points: baseline/randomization visit, maximum of 3 treatment visits (Visits 3, 5, and 9), and Visit 13/Study exit (if applicable), with cultures taken pre- and post- debridement. Wound measurements will be taken via imaging from Silhouette camera system at every in-clinic visit.
Interventions
DEVICEAntibacterial Control Group
Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
DEVICENext Science Group
TorrentX Wound Wash will be used for irrigation and then BlastX Wound Gel will be applied to the wound after debridement/irrigation during in-clinic visits. BlastX Wound Gel will be re-applied again during mid-week dressing change. Dressing used will be plain foam dressing from control group arm.
DEVICEControl Group
Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
Sponsors
Next Science TM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study model is modified psuedo-factorial design with a parallel base. The Next Science treatment arm (using TorrentX Wound Wash and BlastX Wound Gel) is compared against 2 controls, one using a standard dressing and another using a standard dressing with an antimicrobial component.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years or older 2. Presence of full-thickness chronic wound for more than one month (i.e. chronic) 3. Ulcer must be greater than 1 cm2 to enable biofilm sampling 4. He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period 5. Willing to comply with all study procedures and be available for the duration of the study 6. Provide signed and dated informed consent
Exclusion criteria
1. Subjects unable to provide signed and dated informed consent 2. Male or female less than 18 years old 3. Presence of a full-thickness chronic wound for less than one month 4. Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely 5. Subjects whose wound is less than 1 cm2 6. He/she requires endovascular or surgical arterial intervention during the study period 7. Subject with known allergic reaction to the study products ingredients 8. Wound, in the investigator's clinical judgment, is not amenable to management solely with the techniques described in this study (i.e., should be managed in addition with hyperbaric oxygen, vacuum suction, or other adjunctive methods)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Size and Volume | 12 weeks | Significantly Reduced Wound Size and Volume (measured using Aranz Aranz Medical Silhouette Imaging System) at One or More of the Measured Time Points with Next Science Group compared to Control Group(s) |
| Wound Closure | 12 weeks | Significantly Earlier Wound Time to Closure at One or More of the Measured Time Points with Next Science Group compared to Control Group(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colony Forming Units | 12 weeks | Reduction of viable bacteria in the Next Science test group at one or more of the time points compared to the control group(s) as measured by Colony Forming Units. |
| DNA Quantification | 12 weeks | Reduction of bacteria in the Next Science test group at one or more of the times points compared to the control group(s) as measured by DNA quantification. |
| Bacterial species change | 12 weeks | Changes in bacterial species will also be analyzed |
Countries
United States
Outcome results
None listed