Wound Chronic Draining
Conditions
Brief summary
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the Continuation of Treatment Informed Consent and the rational for continuation is documented by the investigator.
Interventions
DEVICENext Science Wound Gel
DRUGTriple Antibiotic Ointment Neosporin
Subjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment: * Subject may continue the application of Neosporin until wound closure or * Subject may cross over to the treatment group for 3 months
Sponsors
Mayo Clinic
Jacksonville Center For Clinical Research
Next Science TM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 18 years or older * Presence of full-thickness wound for more than one month (i.e. chronic) * Ulcer must be greater than 1 centimeter in area to enable biofilm sampling * NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound * Willing to comply with all study procedures and be available for the duration of the study * Provide signed and dated informed consent
Exclusion criteria
* Subjects unable to provide signed and dated informed consent * Male or female less than 18 years old * Presence of a full-thickness wound for less than one month * A candidate for vascular reconstructive surgery to restore blood flow to the wound * Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely * Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling * Subject with known allergic reaction to the study products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound Size Reduction | 2, 4, 8 and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Wound Closure | 2, 4, 8 and 12 weeks |
Other
| Measure | Time frame |
|---|---|
| Reduction of bacterial species types and amounts | 0 and 4 weeks |
Countries
United States
Outcome results
None listed