New Mexico Honey Wound Treatment Research Study

NCT01748318 | Unknown Phase 2

• 1 other identifier: IND 115653
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Methicillin-resistant Staphylococcus Aureus Infection

Keywords

Community acquired MRSA; New Mexico Honey

Outcome Measures

Primary Outcomes (1)

• Size of lesion at day 7

  Increase in size will determine failure; Decrease in size will determine success

  7 days

Study Arms (2)

NM Regional Honey

EXPERIMENTAL

15 ml of NM Honey applied directly to wound

Drug: New Mexico Honey; Drug: Bactrim DS

Bactrim DS

ACTIVE COMPARATOR

Standard of Care Oral Antibiotic

Drug: New Mexico Honey; Drug: Bactrim DS

Interventions

New Mexico Honey DRUG

Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment

Also known as: Local New Mexico Honey

Bactrim DS; NM Regional Honey

Bactrim DS DRUG

Bactrim DS

Also known as: sulfamethoxazle-trimethroprim DS

Bactrim DS; NM Regional Honey

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• R. Stephen Rankin, M.D.: lead

Study Sites (1)

Pinon Family Practice

Farmington, New Mexico, 87401, United States

RECRUITING

MeSH Terms

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• R Stephen Rankin, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R Stephen Rankin, MD

CONTACT

505 324 1000; rstephen_rankin@msn.com

Joseph Pope, MD

CONTACT

505 324 1000; jpope10@msn.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: March 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)