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New Mexico Honey Wound Treatment Research Study

This study is not yet open for participant recruitment.
Verified December 2012 by Rankin, R. Stephen, M.D.
Sponsor:
Information provided by (Responsible Party):
R. Stephen Rankin, M.D., Rankin, R. Stephen, M.D.
ClinicalTrials.gov Identifier:
NCT01748318
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Community-acquired MRSA Infection
 Drug: New Mexico Honey
Drug: Bactrim DS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Mexico Honey Wound Treatment Research Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Rankin, R. Stephen, M.D.:

Primary Outcome Measures:
  • Size of lesion at day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Increase in size will determine failure; Decrease in size will determine success


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NM Regional Honey
15 ml of NM Honey applied directly to wound
 Drug: New Mexico Honey
Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment
Other Name: Local New Mexico Honey
Drug: Bactrim DS
Bactrim DS
Other Name: sulfamethoxazle-trimethroprim DS
Active Comparator: Bactrim DS
Standard of Care Oral Antibiotic
 Drug: New Mexico Honey
Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment
Other Name: Local New Mexico Honey
Drug: Bactrim DS
Bactrim DS
Other Name: sulfamethoxazle-trimethroprim DS

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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748318

Contacts
Contact: R Stephen Rankin, MD 505 324 1000 rstephen_rankin@msn.com
Contact: Joseph Pope, MD 505 324 1000 jpope10@msn.com

Locations
United States, New Mexico
Pinon Family Practice Not yet recruiting
Farmington, New Mexico, United States, 87401
Contact: R Stephen Rankin, MD     505-324-1000        
Principal Investigator: R Stephen Rankin, MD            
Sponsors and Collaborators
R. Stephen Rankin, M.D.
Investigators
Principal Investigator: R Stephen Rankin, MD
  More Information

No publications provided

Responsible Party: R. Stephen Rankin, M.D., Primary Investigator, Rankin, R. Stephen, M.D.
ClinicalTrials.gov Identifier: NCT01748318     History of Changes
Other Study ID Numbers: IND 115653
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rankin, R. Stephen, M.D.:
Community acquired MRSA
New Mexico Honey

Additional relevant MeSH terms:
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013