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

Primary Purpose

Wound Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NXTSC wound gel
NXTSC wound gel plus Standard of Care
Standard of Care Group
Sponsored by
Southwest Regional Wound Care Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Regional Wound Care Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

NXTSC

NXTSC plus SOC

SOC

Arm Description

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).

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2014
Last Updated
November 21, 2019
Sponsor
Southwest Regional Wound Care Center
Collaborators
Next Science TM
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1. Study Identification

Unique Protocol Identification Number
NCT02465073
Brief Title
The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds
Official Title
The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southwest Regional Wound Care Center
Collaborators
Next Science TM

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NXTSC
Arm Type
Active Comparator
Arm Description
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).
Arm Title
NXTSC plus SOC
Arm Type
Active Comparator
Arm Description
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).
Arm Title
SOC
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
NXTSC wound gel
Other Intervention Name(s)
NXTSC
Intervention Description
Subjects will receive NXTSC wound gel only.
Intervention Type
Device
Intervention Name(s)
NXTSC wound gel plus Standard of Care
Other Intervention Name(s)
NXTSC + SOC
Intervention Description
Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.
Intervention Type
Device
Intervention Name(s)
Standard of Care Group
Other Intervention Name(s)
SOC
Intervention Description
Subjects will receive Standard of Care only.
Primary Outcome Measure Information:
Title
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
Time Frame
Percentage after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall D Wolcott, M.D.
Organizational Affiliation
Southwest Regional Wound Care Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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