Evaluating Wound Healing With Next Science Gel & Wash.

Not Applicable

Terminated

• Conditions: Chronic Wound
• Interventions: Device: Control Group; Device: Antibacterial Control Group; Device: Next Science Group

• Registration Number: NCT03738579
• Lead Sponsor: Next Science TM

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.

Study Timeline

• Study Start: 2018-10-17
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control 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.
Antibacterial Control	Antibacterial Control Group	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.
Next Science Group	Next Science Group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bacterial species change	12 weeks	Changes in bacterial species will also be analyzed
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.

Trial Locations

Locations (1)

Advancing the Zenith of Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States