Back to resultsNext Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Primary Purpose
Wound Chronic Draining
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Next Science Wound Gel
Triple Antibiotic Ointment Neosporin
Sponsored by
About this trial
This is an interventional treatment trial for Wound Chronic Draining
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Florida
- Jacksonville Center for Clinical Research - RCCR location
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Triple Antibiotic Ointment Neosporin
Next Science Wound Gel
Arm Description
Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider.
Outcomes
Primary Outcome Measures
Wound Size Reduction
Secondary Outcome Measures
Wound Closure
Full Information
NCT ID
NCT02138994
First Posted
May 12, 2014
Last Updated
March 27, 2017
Sponsor
Next Science TM
Collaborators
Mayo Clinic, Jacksonville Center For Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT02138994
Brief Title
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Official Title
Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
Collaborators
Mayo Clinic, Jacksonville Center For Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Chronic Draining
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triple Antibiotic Ointment Neosporin
Arm Type
Active Comparator
Arm Description
Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
Arm Title
Next Science Wound Gel
Arm Type
Experimental
Arm Description
Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider.
Intervention Type
Device
Intervention Name(s)
Next Science Wound Gel
Intervention Type
Drug
Intervention Name(s)
Triple Antibiotic Ointment Neosporin
Intervention Description
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
Primary Outcome Measure Information:
Title
Wound Size Reduction
Time Frame
2, 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Wound Closure
Time Frame
2, 4, 8 and 12 weeks
Other Pre-specified Outcome Measures:
Title
Reduction of bacterial species types and amounts
Time Frame
0 and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Jacksonville Center for Clinical Research - RCCR location
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
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