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

NCT02465073 | Completed Results

• 1 other identifier: 56-RW-027
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

NXTSC

ACTIVE COMPARATOR

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

NXTSC plus SOC

ACTIVE COMPARATOR

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

SOC

ACTIVE COMPARATOR

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

Interventions

NXTSC wound gel DEVICE

Subjects will receive NXTSC wound gel only.

Also known as: NXTSC

NXTSC

NXTSC wound gel plus Standard of Care DEVICE

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

Also known as: NXTSC + SOC

NXTSC plus SOC

Standard of Care Group DEVICE

Subjects will receive Standard of Care only.

Also known as: SOC

SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead
• Next Science TM: collaborator

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Randall Wolcott
• Organization: Southwest Regional Wound Care Center

randy@randallwolcott.com

806-793-8869

Study Officials

• Randall D Wolcott, M.D.

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: June 8, 2015
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 25, 2019
• Results First Posted: January 18, 2016

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)