Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT01748318
Status:
UNKNOWN
Last Update Posted:
2016-05-10
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Mexico Honey Wound Treatment Research Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-06', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of lesion at day 7', 'timeFrame': '7 days', 'description': 'Increase in size will determine failure; Decrease in size will determine success'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community acquired MRSA', 'New Mexico Honey'], 'conditions': ['Community-acquired Methicillin-resistant Staphylococcus Aureus Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 16 years of age or older\n* Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage\n* Patient willing to try honey prepared dressing\n* Patient able to return to office each day for 7 days for evaluation\n\nExclusion Criteria:\n\n* Under the age of 16\n* Abscess of face, scalp or genitals\n* Diagnosed as a diabetic\n* Allergic to bee pollen, honey or sulfa antibiotics\n* Diagnosed with peripheral vascular disease\n* Patient acknowledgement of current drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01748318', 'briefTitle': 'New Mexico Honey Wound Treatment Research Study', 'organization': {'class': 'INDIV', 'fullName': 'Rankin, R. Stephen, M.D.'}, 'officialTitle': 'New Mexico Honey Wound Treatment Research Study', 'orgStudyIdInfo': {'id': 'IND 115653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NM Regional Honey', 'description': '15 ml of NM Honey applied directly to wound', 'interventionNames': ['Drug: New Mexico Honey', 'Drug: Bactrim DS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bactrim DS', 'description': 'Standard of Care Oral Antibiotic', 'interventionNames': ['Drug: New Mexico Honey', 'Drug: Bactrim DS']}], 'interventions': [{'name': 'New Mexico Honey', 'type': 'DRUG', 'otherNames': ['Local New Mexico Honey'], 'description': 'Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment', 'armGroupLabels': ['Bactrim DS', 'NM Regional Honey']}, {'name': 'Bactrim DS', 'type': 'DRUG', 'otherNames': ['sulfamethoxazle-trimethroprim DS'], 'description': 'Bactrim DS', 'armGroupLabels': ['Bactrim DS', 'NM Regional Honey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87401', 'city': 'Farmington', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'R Stephen Rankin, MD', 'role': 'CONTACT', 'phone': '505-324-1000'}, {'name': 'R Stephen Rankin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pinon Family Practice', 'geoPoint': {'lat': 36.72806, 'lon': -108.21869}}], 'centralContacts': [{'name': 'R Stephen Rankin, MD', 'role': 'CONTACT', 'email': 'rstephen_rankin@msn.com', 'phone': '505 324 1000'}, {'name': 'Joseph Pope, MD', 'role': 'CONTACT', 'email': 'jpope10@msn.com', 'phone': '505 324 1000'}], 'overallOfficials': [{'name': 'R Stephen Rankin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R. Stephen Rankin, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'R. Stephen Rankin, M.D.', 'investigatorAffiliation': 'Rankin, R. Stephen, M.D.'}}}}