Chronic Wound Clinical Trial
Official title:
Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science BlastX Antimicrobial Wound Gel and TorrentX Wound Wash
NCT number | NCT03738579 |
Other study ID # | CSP-009 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 17, 2018 |
Est. completion date | June 25, 2019 |
Verified date | November 2023 |
Source | Next Science TM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | June 25, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Advancing the Zenith of Healthcare | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Next Science TM |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound Size and Volume | 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) | 12 weeks | |
Primary | Wound Closure | Significantly Earlier Wound Time to Closure at One or More of the Measured Time Points with Next Science Group compared to Control Group(s) | 12 weeks | |
Secondary | Colony Forming Units | 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. | 12 weeks | |
Secondary | DNA Quantification | 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. | 12 weeks | |
Secondary | Bacterial species change | Changes in bacterial species will also be analyzed | 12 weeks |
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