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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465073
• Other study ID #: 56-RW-027
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2019
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Infection
• Wounds and Injuries

Intervention

Device:
• NXTSC wound gel
Subjects will receive NXTSC wound gel only.
• NXTSC wound gel plus Standard of Care
Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.
• Standard of Care Group
Subjects will receive Standard of Care only.

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center	Next Science TM

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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