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Clinical Trials/NCT01748318
NCT01748318
Unknown
Phase 2

New Mexico Honey Wound Treatment Research Study

R. Stephen Rankin, M.D.1 site in 1 country60 target enrollmentStarted: March 2013Last updated:

Overview

Phase
Phase 2
Sponsor
R. Stephen Rankin, M.D.
Enrollment
60
Locations
1
Primary Endpoint
Size of lesion at day 7

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

NM Regional Honey

Experimental

15 ml of NM Honey applied directly to wound

Intervention: New Mexico Honey (Drug)

NM Regional Honey

Experimental

15 ml of NM Honey applied directly to wound

Intervention: Bactrim DS (Drug)

Bactrim DS

Active Comparator

Standard of Care Oral Antibiotic

Intervention: New Mexico Honey (Drug)

Bactrim DS

Active Comparator

Standard of Care Oral Antibiotic

Intervention: Bactrim DS (Drug)

Outcomes

Primary Outcomes

Size of lesion at day 7

Time Frame: 7 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
R. Stephen Rankin, M.D.
Sponsor Class
Indiv
Responsible Party
Sponsor Investigator
Principal Investigator

R. Stephen Rankin, M.D.

Primary Investigator

Rankin, R. Stephen, M.D.

Study Sites (1)

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