Back to resultsNew Mexico Honey Wound Treatment Research Study
Primary Purpose
Community-acquired Methicillin-resistant Staphylococcus Aureus Infection
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
New Mexico Honey
Bactrim DS
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Methicillin-resistant Staphylococcus Aureus Infection focused on measuring Community acquired MRSA, New Mexico Honey
Eligibility Criteria
Inclusion Criteria:
- Patients 16 years of age or older
- Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage
- Patient willing to try honey prepared dressing
- Patient able to return to office each day for 7 days for evaluation
Exclusion Criteria:
- Under the age of 16
- Abscess of face, scalp or genitals
- Diagnosed as a diabetic
- Allergic to bee pollen, honey or sulfa antibiotics
- Diagnosed with peripheral vascular disease
- Patient acknowledgement of current drug or alcohol abuse
Sites / Locations
- Pinon Family PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NM Regional Honey
Bactrim DS
Arm Description
15 ml of NM Honey applied directly to wound
Standard of Care Oral Antibiotic
Outcomes
Primary Outcome Measures
Size of lesion at day 7
Increase in size will determine failure; Decrease in size will determine success
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01748318
Brief Title
New Mexico Honey Wound Treatment Research Study
Official Title
New Mexico Honey Wound Treatment Research Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
R. Stephen Rankin, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community Acquired MRSA.
Detailed Description
Locally grown New Mexico Honey will be utilized on abscess wounds of the trunk and extremities vs routine (Bactrim) antibiotic care to determine if NM Honey is effective treatment for Community Acquired MRSA 6 cm abscesses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Methicillin-resistant Staphylococcus Aureus Infection
Keywords
Community acquired MRSA, New Mexico Honey
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NM Regional Honey
Arm Type
Experimental
Arm Description
15 ml of NM Honey applied directly to wound
Arm Title
Bactrim DS
Arm Type
Active Comparator
Arm Description
Standard of Care Oral Antibiotic
Intervention Type
Drug
Intervention Name(s)
New Mexico Honey
Other Intervention Name(s)
Local New Mexico Honey
Intervention Description
Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment
Intervention Type
Drug
Intervention Name(s)
Bactrim DS
Other Intervention Name(s)
sulfamethoxazle-trimethroprim DS
Intervention Description
Bactrim DS
Primary Outcome Measure Information:
Title
Size of lesion at day 7
Description
Increase in size will determine failure; Decrease in size will determine success
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients 16 years of age or older
Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage
Patient willing to try honey prepared dressing
Patient able to return to office each day for 7 days for evaluation
Exclusion Criteria:
Under the age of 16
Abscess of face, scalp or genitals
Diagnosed as a diabetic
Allergic to bee pollen, honey or sulfa antibiotics
Diagnosed with peripheral vascular disease
Patient acknowledgement of current drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R Stephen Rankin, MD
Phone
505 324 1000
Email
rstephen_rankin@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Pope, MD
Phone
505 324 1000
Email
jpope10@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Stephen Rankin, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinon Family Practice
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Stephen Rankin, MD
Phone
505-324-1000
First Name & Middle Initial & Last Name & Degree
R Stephen Rankin, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
New Mexico Honey Wound Treatment Research Study
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