NCT06420934

Brief Summary

This study aims to determine whether the use of two sterile towels for drying after surgical handwashing results in fewer contamination events compared to the use of only one towel among healthcare personnel. This randomized, multicenter, superiority-controlled trial will enroll up to 72 healthcare workers and surgical residents from three hospitals in Bogotá, Colombia. A fluorescent product will simulate bacteria, and contamination will be assessed by evaluating the presence of fluorescent cream after hand drying technique with either two or one surgical sterile towel. Data will be collected through REDCap and deidentified. Differences in the proportion of contamination between the two groups will be assessed using an exact Fischer test, and confounding variables will be included in the analysis through logistic multivariate regression, with a significance level set a priori at 0.05. Results will be submitted for publication in a peer-reviewed journal.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

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

Study Start

First participant enrolled

April 26, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

May 15, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

Surgical ScrubbingHandwashingDisinfectionHealthcare Associated InfectionHand Hygiene

Outcome Measures

Primary Outcomes (1)

  • Contamination

    Presence or absence of fluorescent cream on the upper extremities will be evaluated using a UV light lamp in a dark room. If fluorescence is observed in the washed area where it was not applied, it will be considered that there was contamination during the hand drying process.

    3 minutes after handwash and hand drying.

Study Arms (2)

One surgical towel

ACTIVE COMPARATOR

Participants will be asked to remove all accessories from the forearm, wrist, fingers and to roll up any clothing until at least 5 cm above the humeral condyles are exposed. They will be instructed to perform conventional surgical scrubbing and to dry their hands with a conventional paper towel. The research assistant will open the opaque envelope, which will indicate that the participant needs to dry their hands with one surgical towel.

Other: Drying procedure after surgical handwashing

Two surgical towel

EXPERIMENTAL

Participants will be asked to remove all accessories from the forearm, wrist, fingers and to roll up any clothing until at least 5 cm above the humeral condyles are exposed. They will be instructed to perform conventional surgical scrubbing and to dry their hands with a conventional paper towel. The research assistant will open the opaque envelope, which will indicate that the participant needs to dry their hands with two surgical towels, one for each hand.

Other: Drying procedure after surgical handwashing

Interventions

Participants will dry their hands with one surgical towel

One surgical towelTwo surgical towel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Workers and students who have a current affiliation with the institutions where the study will be executed.
  • Workers and students whose practice or work involves performing surgical handwashing at least once a week for invasive procedures.

You may not qualify if:

  • Workers and students who do not wish to participate in the study.
  • Workers and students whose work activities do not allow them time to participate in the study.
  • Workers and students who are allergic to the fluorescent cream
  • Workers and students whose nails exceed a length of 0.5 cm from the fingertip edge.
  • Workers and students whose nails are painted with polish.
  • Workers and students who refuse to remove jewelry and accessories from wrists and hands.
  • Workers and students with recent wounds on hands or forearms, including tattoos done in the last month.
  • Workers and students who do not adhere to the handwashing and drying technique taught prior to the study's implementation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Ortopedia Infantil Roosevelt

Bogotá, Bogota D.C., 110231, Colombia

RECRUITING

Related Publications (11)

  • WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/

    PMID: 23805438BACKGROUND
  • Nicolay CR. Hand hygiene: an evidence-based review for surgeons. Int J Surg. 2006;4(1):53-65. doi: 10.1016/j.ijsu.2005.06.002. Epub 2005 Aug 1.

    PMID: 17462314BACKGROUND
  • Huang C, Ma W, Stack S. The hygienic efficacy of different hand-drying methods: a review of the evidence. Mayo Clin Proc. 2012 Aug;87(8):791-8. doi: 10.1016/j.mayocp.2012.02.019. Epub 2012 May 31.

    PMID: 22656243BACKGROUND
  • Gustafson DR, Vetter EA, Larson DR, Ilstrup DM, Maker MD, Thompson RL, Cockerill FR 3rd. Effects of 4 hand-drying methods for removing bacteria from washed hands: a randomized trial. Mayo Clin Proc. 2000 Jul;75(7):705-8. doi: 10.4065/75.7.705.

    PMID: 10907386BACKGROUND
  • Suen LKP, Lung VYT, Boost MV, Au-Yeung CH, Siu GKH. Microbiological evaluation of different hand drying methods for removing bacteria from washed hands. Sci Rep. 2019 Sep 24;9(1):13754. doi: 10.1038/s41598-019-50239-4.

    PMID: 31551459BACKGROUND
  • Mutters R, Warnes SL. The method used to dry washed hands affects the number and type of transient and residential bacteria remaining on the skin. J Hosp Infect. 2019 Apr;101(4):408-413. doi: 10.1016/j.jhin.2018.12.005. Epub 2018 Dec 8.

    PMID: 30537524BACKGROUND
  • Handaya AY, Werdana VAP. Adherence to preoperative hand hygiene and sterile gowning technique among consultant surgeons, surgical residents, and nurses: a pilot study at an academic medical center in Indonesia. Patient Saf Surg. 2019 Mar 11;13:11. doi: 10.1186/s13037-019-0193-5. eCollection 2019.

    PMID: 30899331BACKGROUND
  • Skodova M, Garcia Urra F, Gimeno Benitez A, Jimenez Romano MR, Gimeno Ortiz A. Hand hygiene assessment in the workplace using a UV lamp. Am J Infect Control. 2015 Dec 1;43(12):1360-2. doi: 10.1016/j.ajic.2015.07.003. Epub 2015 Aug 18.

    PMID: 26297523BACKGROUND
  • Szilagyi L, Lehotsky A, Nagy M, Haidegger T, Benyo B, Benyo Z. Stery-hand: A new device to support hand disinfection. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:4756-9. doi: 10.1109/IEMBS.2010.5626377.

    PMID: 21096021BACKGROUND
  • Sakmen KD, Sterz J, Stefanescu MC, Zabel J, Lehmann M, Ruesseler M. Impact of the teaching method of the rub-in technique for learning hygienic hand disinfection in medical studies: a comparative effectiveness analysis of two techniques. GMS Hyg Infect Control. 2019 Nov 13;14:Doc17. doi: 10.3205/dgkh000332. eCollection 2019.

    PMID: 31815090BACKGROUND
  • Marena C, Lodola L, Zecca M, Bulgheroni A, Carretto E, Maserati R, Zambianchi L. Assessment of handwashing practices with chemical and microbiologic methods: preliminary results from a prospective crossover study. Am J Infect Control. 2002 Oct;30(6):334-40. doi: 10.1067/mic.2002.125809.

    PMID: 12360141BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionCross Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsIatrogenic DiseaseDisease Attributes

Central Study Contacts

Monica Botero-Bermúdez, MD, MSc

CONTACT

Maria F Garcia, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking will be provided to data analysis expert.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

April 26, 2024

Primary Completion

December 30, 2024

Study Completion

June 30, 2025

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations