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Evaluating Wound Healing With Next Science Gel & Wash.

NCT03738579 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-03

No results posted yet for this study

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

Interventions

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.

DEVICE

Control Group

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

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.

Sponsors & Collaborators

  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Jeffrey Niezgoda, MD · Advancing the Zenith of Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2019-06-25
Completion
2019-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738579 on ClinicalTrials.gov