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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. Determine the effect on wound treatment outcomes using standard of care treatment. (SOC).

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

Conditions
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Wound Infection

Intervention / Treatment
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* Device: NXTSC wound gel
* Device: NXTSC wound gel plus Standard of Care
* Device: Standard of Care Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must have a full-thickness chronic wound for greater than one month. The subject must be at least 18 years of age. The ulcer to be biopsied must be greater than 1 centimeter in area. The subject must be able to give informed consent. Exclusion Criteria: Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NXTSC<br>This group will receive the NXTSC gel only. The NXTSC wound gel and its active agents are applied on the wound bed. A synthetic microfiber dressing will be applied to the surface of the wound. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site. ( NXTSC). | Device: NXTSC wound gel<br>* Subjects will receive NXTSC wound gel only.<br>* Other names: NXTSC;|
| Active Comparator: NXTSC plus SOC<br>This group will receive the NXTSC wound gel plus Standard of Care. The NXTSC wound gel is applied to the wound bed. Local wound management will consist of diagnosing the wound biofilm and providing specific measures to suppress the wound biofilm to allow host healing. 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.( Next Science Wound Gel, plus standard of care). | Device: NXTSC wound gel plus Standard of Care<br>* Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.<br>* Other names: NXTSC + SOC;|
| Active Comparator: SOC<br>This group will receive Standard of Care only. The Standard of Care is based on wound management intervention to remove wound slough by frequent debridement. Moist interactive wound care with multiple strategies to suppress biofilm is instituted. Determine the effect on wound treatment outcomes using standard of care treatment | Device: Standard of Care Group<br>* Subjects will receive Standard of Care only.<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Percentage after 4 weeks |