Surgical Handwashing: Drying With One or Two Surgical Towels

NCT ID: NCT06420934

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-26
• Study Completion Date: 2025-06-30

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.

Detailed Description

Approval was obtained from the ethics committee of three healthcare institutions. A process of informed consent will be conducted with all participants, and confidentiality and data protection will be guaranteed. A research assistant, unaware of the operational hypotheses and study objectives, will execute the experiment and record the results. There will be no blinding of the intervention for the participants or the assistant. At each institution, randomization will be conducted a priori to determine the operating room where participants should be recruited. Likewise, the intervention to be administered will be randomized. All these data will be stored in opaque envelopes that will be opened at the time of recruitment. A total of 72 participants will be recruited, with 36 exposed to drying with one towel and 36 to drying with two towels. Recruitment will cease upon completion of the respective participants stipulated for each intervention.

The primary outcome of interest will be the presence or absence of contamination. To evaluate this outcome, the gold standard would be the collection of cultures and the analysis of the presence or absence of bacterial contamination. However, due to the costs and methodological difficulties of taking cultures, an indirect method, previously validated as a surrogate, will be employed instead. 2 mL of fluorescent cream (Glo Germ ™) will be applied with a brush proximal to the normally washed area during surgical scrubbing (3 cm above the elbow). Participants will be shown a video on how to dry with one or two surgical towels and will be given one minute to do so. Subsequently, the presence or absence of fluorescent cream on the upper extremities will be evaluated using a UV light lamp. If fluorescence is evidenced in the washed area where it was not applied, it will be considered that there was contamination during the hand drying process.

No interim analyses will be executed. Data will be de-identified for the analysis. Descriptive statistics will be conducted using R studio, and proportions of contamination when drying with one or two towels will be compared. A simple logistic regression will be performed to assess the relationship between the intervention and the proportion of contamination events, and a multivariate logistic regression will be conducted to assess the effect of confounding variables on the outcome. The results will be reported collectively for publication in a peer-reviewed journal.

Conditions

Hand Hygiene; Surgical Wound Infection; Healthcare Associated Infection; Medical Errors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

One surgical towel

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.

Group Type: ACTIVE_COMPARATOR

Drying procedure after surgical handwashing

Intervention Type: OTHER

Participants will dry their hands with one surgical towel

Two surgical towel

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.

Group Type: EXPERIMENTAL

Drying procedure after surgical handwashing

Intervention Type: OTHER

Participants will dry their hands with one surgical towel

Interventions

Drying procedure after surgical handwashing

Participants will dry their hands with one surgical towel

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario San Ignacio

OTHER

Sponsor Role: collaborator

Hospital Militar Central, Argentina

OTHER

Sponsor Role: collaborator

Instituto de Ortopedia Infantil Roosevelt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Ortopedia Infantil Roosevelt

Bogotá, Bogota D.C., Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Monica Botero-Bermúdez, MD, MSc

Role: CONTACT

monica.botero@javeriana.edu.co

+573203049826

Maria F Garcia, MD, MSc

Role: CONTACT

f.garcia@ioir.org.co

+573208541343

Facility Contacts

Maria Fernanda Garcia, MD, MSc

Role: primary

f.garcia@ioir.org.co

+573208541343

Manuela Quiroga-Carrillo, MD

Role: backup

mquiroga@ioir.org.co

+576013534000 ext. 263

References

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Other Identifiers

2022121502-001

Identifier Type: -

Identifier Source: org_study_id