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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NXTSC

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).

Group Type ACTIVE_COMPARATOR

NXTSC wound gel

Intervention Type DEVICE

Subjects will receive NXTSC wound gel only.

NXTSC plus SOC

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).

Group Type ACTIVE_COMPARATOR

NXTSC wound gel plus Standard of Care

Intervention Type DEVICE

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

SOC

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

Group Type ACTIVE_COMPARATOR

Standard of Care Group

Intervention Type DEVICE

Subjects will receive Standard of Care only.

Interventions

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NXTSC wound gel

Subjects will receive NXTSC wound gel only.

Intervention Type DEVICE

NXTSC wound gel plus Standard of Care

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

Intervention Type DEVICE

Standard of Care Group

Subjects will receive Standard of Care only.

Intervention Type DEVICE

Other Intervention Names

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NXTSC NXTSC + SOC SOC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No