Clinical trial NCT03738579: Evaluating Wound Healing With Next Science Gel & Wash.
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Wound
Keywords: biofilm
EPS matrix
antimicrobial
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study model is modified psuedo-factorial design with a parallel base. The Next Science treatment arm (using TorrentX Wound Wash and BlastX Wound Gel) is compared against 2 controls, one using a standard dressing and another using a standard dressing with an antimicrobial component.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Wound Size and Volume
timeFrame: 12 weeks
measure: Wound Closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Colony Forming Units
timeFrame: 12 weeks
measure: DNA Quantification
timeFrame: 12 weeks
measure: Bacterial species change
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Advancing the Zenith of Healthcare
state: Wisconsin
Study officials:
affiliation: Advancing the Zenith of Healthcare
name: Jeffrey Niezgoda, MD
role: PRINCIPAL_INVESTIGATOR
References: