Evaluating Wound Healing With Next Science Gel & Wash.

NCT ID: NCT03738579

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2019-06-25

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.

Conditions

Chronic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: DEVICE

Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.

Antibacterial Control

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.

Group Type: ACTIVE_COMPARATOR

Antibacterial Control Group

Intervention Type: DEVICE

Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.

Next Science 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.

Group Type: EXPERIMENTAL

Next Science Group

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Control Group

Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

TorrentX and BlastX; Foam Dressing; Mepilex Foam Dressing; Silver-based Foam Dressing; Mepilex Ag Foam Dressing

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Next Science TM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Niezgoda, MD

Role: PRINCIPAL_INVESTIGATOR

Advancing the Zenith of Healthcare

Locations

Advancing the Zenith of Healthcare

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CSP-009

Identifier Type: -

Identifier Source: org_study_id