Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science Wound Gel and Wash
Chronic Wound
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
Active Comparator
Active Comparator
Experimental
Control Group
Antibacterial Control
Next Science Group
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.