- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05937412
A Comparative Study Between Honey and Alcohol as Topical Skin Disinfectant
Skin antisepsis is essential in every healthcare environment. Alcohol/chlorhexidine use might disrupt skin microbiota and lead to antibiotic resistance.
This study investigates honey (being natural product with many beneficial therapeutic effects) as topical skin anti-septic agent and compares it with alcohol, in terms of effectiveness and safety.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent years' investigations of the co-evolution and functional integration of the human body and its commensal microbiota have disclosed that the microbiome has a major impact on physiological functions including protection against infections.
Invasive procedures such as injections, punctures or surgeries penetrate the skin's natural protective barrier, which may allow pathogenic microorganisms to enter deeper skin layers and cavities and trigger infections there.
Alcohols usually in the form of 70% isopropyl alcohol or 60 to 80% ethyl alcohol, are commonly used topical disinfectants.
Despite being efficiently broad-spectrum antiseptic, Alcohol shows some local hazards affecting skin integrity and microbiome.
Honey has been used in wound care since ancient. It has many beneficial therapeutic effects, including anti-microbia, antioxidant, immune-modulator, wound healing and synbiotic effects .
Antimicrobial agents are important in reducing the burden of infectious diseases.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ahmed badr
- Phone Number: 00201093562378
- Email: abn777777@yahoo.com
Study Contact Backup
- Name: yosra awad
- Phone Number: 00201001831590
- Email: yosraawad@med.asu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 1181
- Recruiting
- Ain shams university, Cairo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Children aged from 2 to 12 years, of both sexes, and with apparently healthy skin.
- Children, who did not receive any form of antimicrobial agent for at least one-week prior study.
Exclusion Criteria:
- - Immuno-compromised due to diseases or drugs.
- - Children having any skin disease as eczema or others
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: alcohol group
70% isopropyl alcohol will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand.
A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey.
|
Sterilizing skin using alcohol
|
|
Active Comparator: honey group
honey will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand.
A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey.
|
Sterilizing skin using honey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess efficacy of honey as a disinfectant in comparison to the standard disinfectant which is alcohol
Time Frame: 3 months
|
taking a swab from skin for culture of organisms after application of either alcohol or honey and compare type of organisms and number of colony forming units
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: mamdouh abdelmaksoud, Ain Shams University
- Study Director: yosra awad, Ain Shams University
- Study Director: maha ahmad, Ain Shams University
Publications and helpful links
General Publications
- Breasted JH. (1930): The Edwin Smith papyrus: published in facsimile and hieroglyphic transliteration. Chicago: University of Chicago Press.
- Wiemken TL. Skin antiseptics in healthcare facilities: is a targeted approach necessary? BMC Public Health. 2019 Aug 22;19(1):1158. doi: 10.1186/s12889-019-7507-5.
- Gheldof N, Engeseth NJ. Antioxidant capacity of honeys from various floral sources based on the determination of oxygen radical absorbance capacity and inhibition of in vitro lipoprotein oxidation in human serum samples. J Agric Food Chem. 2002 May 8;50(10):3050-5. doi: 10.1021/jf0114637.
- Hasyimi W, Widanarni W, Yuhana M. Growth Performance and Intestinal Microbiota Diversity in Pacific White Shrimp Litopenaeus vannamei Fed with a Probiotic Bacterium, Honey Prebiotic, and Synbiotic. Curr Microbiol. 2020 Oct;77(10):2982-2990. doi: 10.1007/s00284-020-02117-w. Epub 2020 Jul 18.
- Held E, Mygind K, Wolff C, Gyntelberg F, Agner T. Prevention of work related skin problems: an intervention study in wet work employees. Occup Environ Med. 2002 Aug;59(8):556-61. doi: 10.1136/oem.59.8.556.
- Jull AB, Cullum N, Dumville JC, Westby MJ, Deshpande S, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2015 Mar 6;2015(3):CD005083. doi: 10.1002/14651858.CD005083.pub4.
- Majtan J. Honey: an immunomodulator in wound healing. Wound Repair Regen. 2014 Mar-Apr;22(2):187-92. doi: 10.1111/wrr.12117. Epub 2014 Feb 24.
- Mandal MD, Mandal S. Honey: its medicinal property and antibacterial activity. Asian Pac J Trop Biomed. 2011 Apr;1(2):154-60. doi: 10.1016/S2221-1691(11)60016-6.
- Christensen GJ, Bruggemann H. Bacterial skin commensals and their role as host guardians. Benef Microbes. 2014 Jun 1;5(2):201-15. doi: 10.3920/BM2012.0062.
- Sato T, Miyata G. The nutraceutical benefit, part iii: honey. Nutrition. 2000 Jun;16(6):468-9. doi: 10.1016/s0899-9007(00)00271-9. No abstract available.
- Trevisanato SI. Treatments for burns in the London Medical Papyrus show the first seven biblical plagues of Egypt are coherent with Santorini's volcanic fallout. Med Hypotheses. 2006;66(1):193-6. doi: 10.1016/j.mehy.2005.08.052. Epub 2005 Oct 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MS 312/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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