Evaluating Wound Healing With Next Science Gel & Wash.

Next Science

Status: Terminated

Conditions: Chronic Wound

Treatments: Device: Next Science Group; Device: Antibacterial Control Group; Device: Control Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738579

CSP-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Control Group

Active Comparator group

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.

Treatment:

Device: Control Group

Antibacterial Control

Active Comparator group

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.

Treatment:

Device: Antibacterial Control Group

Next Science Group

Experimental group

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.

Treatment:

Device: Next Science Group