An interventional study of Next Science Group and Control Group in Chronic Wound, sponsored by Next Science TM. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by Next Science TM · Not applicable, Interventional, and Treatment
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.
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.
Next Science TM is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Device: Antibacterial Control 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.
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.
Also known as: TorrentX and BlastX
Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
Also known as: Foam Dressing, Mepilex Foam Dressing
Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
Also known as: Silver-based Foam Dressing, Mepilex Ag Foam Dressing
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Bacterial species change
Changes in bacterial species will also be analyzed
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Jun 2019, 8 months.
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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