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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05937412
Other study ID # MS 312/2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 30, 2023
Est. completion date August 28, 2024

Study information

Verified date March 2023
Source Ain Shams University
Contact ahmed badr
Phone 00201093562378
Email abn777777@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date August 28, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Disinfectant Causing Toxic Effect

Intervention

Other:
Alcohol sterilization
Sterilizing skin using alcohol
Honey sterilization
Sterilizing skin using honey

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

References & Publications (11)

Breasted JH. (1930): The Edwin Smith papyrus: published in facsimile and hieroglyphic transliteration. Chicago: University of Chicago Press.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Assess efficacy of honey as a disinfectant in comparison to the standard disinfectant which is alcohol 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03957291 - Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant Early Phase 1