New Mexico Honey Wound Treatment Research Study

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.

Study Overview

• Status: Unknown
• Conditions: Community-acquired Methicillin-resistant Staphylococcus Aureus Infection
• Intervention / Treatment: Drug: New Mexico Honey; Drug: Bactrim 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • Recruiting
      • Pinon Family Practice
      • Contact: R Stephen Rankin, MD; Phone Number: 505-324-1000
      • Principal Investigator: R Stephen Rankin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Local New Mexico Honey; Drug: Bactrim DS; Bactrim DS; Other Names: 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 Names: Local New Mexico Honey; Drug: Bactrim DS; Bactrim DS; Other Names: sulfamethoxazle-trimethroprim DS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of lesion at day 7	Increase in size will determine failure; Decrease in size will determine success	7 days

Collaborators and Investigators

• Sponsor: R. Stephen Rankin, M.D.
• Investigators: Principal Investigator: R Stephen Rankin, MD

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 6, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Community acquired MRSA; New Mexico Honey
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anti-Infective Agents, Urinary; Renal Agents; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: IND 115653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES