Back to resultsAssessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science Wound Gel and Wash
Primary Purpose
Chronic Wound
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Next Science Group
Control Group
Antibacterial Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wound focused on measuring biofilm, EPS matrix, antimicrobial
Eligibility Criteria
Inclusion Criteria:
- Male or female 18 years or older
- Presence of full-thickness chronic wound for more than one month (i.e. chronic)
- Ulcer must be greater than 1 cm2 to enable biofilm sampling
- He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- Willing to comply with all study procedures and be available for the duration of the study
- Provide signed and dated informed consent
Exclusion Criteria:
- Subjects unable to provide signed and dated informed consent
- Male or female less than 18 years old
- Presence of a full-thickness chronic wound for less than one month
- Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
- Subjects whose wound is less than 1 cm2
- He/she requires endovascular or surgical arterial intervention during the study period
- Subject with known allergic reaction to the study products ingredients
- 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)
Sites / Locations
- Advancing the Zenith of Healthcare
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Control Group
Antibacterial Control
Next Science Group
Arm Description
After standard of care debridement and irrigation (using normal saline), Mepilex foam dressing will be used. Foam dressing will be used throughout the study, including for mid-week dressing changes.
After standard of care debridement and irrigation (using normal saline), Mepilex AG foam dressing will be used. This dressing will be used throughout the study, including for mid-week dressing changes.
Standard of care debridement will be performed as well as irrigation using TorrentX Wound Wash,then BlastX Wound gel will be applied to the wound before covering treatment site with Mepilex foam dressing (no AG component). BlastX will re-applied again mid-week during mid-week dressing change.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
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.
Bacterial species change
Changes in bacterial species will also be analyzed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03738579
Brief Title
Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science Wound Gel and Wash
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wound
Keywords
biofilm, EPS matrix, antimicrobial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
After standard of care debridement and irrigation (using normal saline), Mepilex foam dressing will be used. Foam dressing will be used throughout the study, including for mid-week dressing changes.
Arm Title
Antibacterial Control
Arm Type
Active Comparator
Arm Description
After standard of care debridement and irrigation (using normal saline), Mepilex AG foam dressing will be used. This dressing will be used throughout the study, including for mid-week dressing changes.
Arm Title
Next Science Group
Arm Type
Experimental
Arm Description
Standard of care debridement will be performed as well as irrigation using TorrentX Wound Wash,then BlastX Wound gel will be applied to the wound before covering treatment site with Mepilex foam dressing (no AG component). BlastX will re-applied again mid-week during mid-week dressing change.
Intervention Type
Device
Intervention Name(s)
Next Science Group
Other Intervention Name(s)
TorrentX and BlastX
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Group
Other Intervention Name(s)
Foam Dressing, Mepilex Foam Dressing
Intervention Description
Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
Intervention Type
Device
Intervention Name(s)
Antibacterial Control Group
Other Intervention Name(s)
Silver-based Foam Dressing, Mepilex Ag Foam Dressing
Intervention Description
Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
Primary Outcome Measure Information:
Title
Wound Size and Volume
Description
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)
Time Frame
12 weeks
Title
Wound Closure
Description
Significantly Earlier Wound Time to Closure at One or More of the Measured Time Points with Next Science Group compared to Control Group(s)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Colony Forming Units
Description
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.
Time Frame
12 weeks
Title
DNA Quantification
Description
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.
Time Frame
12 weeks
Title
Bacterial species change
Description
Changes in bacterial species will also be analyzed
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 18 years or older
Presence of full-thickness chronic wound for more than one month (i.e. chronic)
Ulcer must be greater than 1 cm2 to enable biofilm sampling
He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
Willing to comply with all study procedures and be available for the duration of the study
Provide signed and dated informed consent
Exclusion Criteria:
Subjects unable to provide signed and dated informed consent
Male or female less than 18 years old
Presence of a full-thickness chronic wound for less than one month
Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
Subjects whose wound is less than 1 cm2
He/she requires endovascular or surgical arterial intervention during the study period
Subject with known allergic reaction to the study products ingredients
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Niezgoda, MD
Organizational Affiliation
Advancing the Zenith of Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advancing the Zenith of Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science Wound Gel and Wash
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