Wound Infection
Conditions
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).
Interventions
DEVICENXTSC wound gel
Subjects will receive NXTSC wound gel only.
DEVICENXTSC wound gel plus Standard of Care
Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.
DEVICEStandard of Care Group
Subjects will receive Standard of Care only.
Sponsors
Next Science TM
Southwest Regional Wound Care Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NXTSC This group will receive the NXTSC gel only.
NXTSC wound gel: Subjects will receive NXTSC wound gel only. | 15 |
| NXTSC Plus SOC This group will receive the NXTSC wound gel plus Standard of Care.
NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only. | 15 |
| Standard of Care This group will receive Standard of Care only.
Standard of Care Group: Subjects will receive Standard of Care only. | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | NXTSC Plus SOC | Standard of Care | NXTSC | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 9 Participants | 34 Participants |
| Age, Continuous | 63 years | 60 years | 57 years | 60 years |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 45 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 5 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: Percentage after 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NXTSC | 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 | 62 percentage of participants |
| NXTSC Plus SOC | 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 | 72 percentage of participants |
| Standard of Care | 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 | 47 percentage of participants |