The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds

Southwest Regional Wound Care Center49 enrolled

Overview

Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.

1. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site. 2. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds when this gel is used in conjunction with the current standard of care infection controls to treat microbial infection at the wound site. 3. Determine the effect on wound treatment outcomes using standard of care treatment. (SOC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Wound Infection

Interventions

NXTSC wound gelDEVICE

Subjects will receive NXTSC wound gel only.

NXTSC wound gel plus Standard of CareDEVICE

Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.

Standard of Care GroupDEVICE

Subjects will receive Standard of Care only.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject must have a full-thickness chronic wound for greater than one month. 2. The subject must be at least 18 years of age. 3. The ulcer to be biopsied must be greater than 1 centimeter in area. 4. The subject must be able to give informed consent. Exclusion Criteria: 1. Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator. 2. Those patients that have significant contributions from other disease processes such as arterial disease (Ankle Brachial Index \[ABI\] less than .7, OR Transcutaneous Partial Oxygen Pressure \[TCpO2 \] less than 20) will be considered to have mixed vascular disease producing their wound and will be excluded from the study.

Locations (1)

Southwest Regional Wound Care Center

Lubbock, Texas, United States

Outcomes

Primary Outcomes

The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care

Time frame: Percentage after 4 weeks

Data from ClinicalTrials.gov

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