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New Mexico Honey Wound Treatment Research Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 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: November 6, 2014
Last verified: November 2014
  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

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 2016
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: November 6, 2014
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
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014