Evaluating Wound Healing With Next Science Gel & Wash.

NCT03738579 | Terminated FDA Device

• 1 other identifier: CSP-009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound

Keywords

biofilm; EPS matrix; antimicrobial

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  12 weeks

Secondary Outcomes (3)

• Colony Forming Units

  12 weeks

• DNA Quantification

  12 weeks

• Bacterial species change

  12 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Antibacterial Control

ACTIVE COMPARATOR

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

Next Science Group

EXPERIMENTAL

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

Interventions

Next Science Group DEVICE

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

Next Science Group

Control Group DEVICE

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

Control Group

Antibacterial Control Group DEVICE

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

Antibacterial Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years or older
• Presence of full-thickness chronic wound for more than one month (i.e. chronic)
• Ulcer must be greater than 1 cm2 to enable biofilm sampling
• He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
• Willing to comply with all study procedures and be available for the duration of the study
• Provide signed and dated informed consent

You may not qualify if:

• Subjects unable to provide signed and dated informed consent
• Male or female less than 18 years old
• Presence of a full-thickness chronic wound for less than one month
• Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
• Subjects whose wound is less than 1 cm2
• He/she requires endovascular or surgical arterial intervention during the study period
• Subject with known allergic reaction to the study products ingredients
• 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)

Sponsors & Collaborators

• Next Science TM: lead

Study Sites (1)

Advancing the Zenith of Healthcare

Milwaukee, Wisconsin, 53221, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jeffrey Niezgoda, MD

  Advancing the Zenith of Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 13, 2018
• Study Start: October 17, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)