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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:July 2013
End Date:March 2015

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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.

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).

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.
We found this trial at
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Lubbock, TX
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