NCT05937412

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

December 10, 2022

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

alcohol group

ACTIVE COMPARATOR

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.

Other: Alcohol sterilization

honey group

ACTIVE COMPARATOR

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.

Other: Honey sterilization

Interventions

Sterilizing skin using alcohol

alcohol group

Sterilizing skin using honey

honey group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Immuno-compromised due to diseases or drugs.
  • \- Children having any skin disease as eczema or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University, Cairo

Cairo, Cairo Governorate, 1181, Egypt

RECRUITING

Related Publications (11)

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

    BACKGROUND
  • 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.

    PMID: 31438910BACKGROUND
  • 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.

    PMID: 11982440BACKGROUND
  • 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.

    PMID: 32683466BACKGROUND
  • 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.

    PMID: 12151613BACKGROUND
  • 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.

    PMID: 25742878BACKGROUND
  • 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.

    PMID: 24612472BACKGROUND
  • 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.

    PMID: 23569748BACKGROUND
  • 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.

    PMID: 24322878BACKGROUND
  • 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.

    PMID: 10869910BACKGROUND
  • 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.

    PMID: 16226847BACKGROUND

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • mamdouh abdelmaksoud

    Ain Shams University

    STUDY DIRECTOR
  • yosra awad

    Ain Shams University

    STUDY DIRECTOR
  • maha ahmad

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2022

First Posted

July 10, 2023

Study Start

August 30, 2023

Primary Completion

July 15, 2025

Study Completion

August 28, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations