NCT03738579

Evaluating Wound Healing With Next Science Gel & Wash.

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Next Science TM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Wound

Interventions

Type	Name	Description
DEVICE	Next 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.
DEVICE	Control Group	Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
DEVICE	Antibacterial Control Group	Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.

Timeline

• Start date: 2018-10-17
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2018-11-13
• Last updated: 2023-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study