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

Not Applicable

Completed

• Conditions: Wound Infection

• Registration Number: NCT02465073
• Lead Sponsor: Southwest Regional Wound Care Center

Brief Summary

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

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-12-19
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Results First Submitted: 2015-12-11
• Results First Submitted QC: 2015-12-11
• Results First Posted: 2016-01-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States