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Surgical ScrubbingNCT04579705

Surgical Hand Scrubbing Methods and the Duration of Scrubbing Time

A study testing Using a brush in people with Surgical Scrubbing and Surgical Site Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical hand scrubbing is the removal of transient flora and reduction of permanent flora as much as possible before any sterile gloves are worn before any surgical intervention. It is a cheap and easy method to prevent infections. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Surgical Scrubbing, Surgical Site Infection
What is being tested?
Using a brush
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Nov 2019to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Being a surgeon or operating room nurse
  • Having six months and more surgical experience
  • Agree to participate in the research

Who cannot join

  • Not wanting to participate in the research
  • Being allergic to the skin due to surgical antiseptic use
  • Being latex allergy
  • Wounds and abrasions on the hand and nail edges
  • To have used a systematic antibiotic at the data collection stage and within two weeks

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Sciences Gulhane Faculty of Nursing

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Surgical Hand Scrubbing Methods and the Duration of Scrubbing Time on the Bacterial Flora

Surgical hand scrubbing is the removal of transient flora and reduction of permanent flora as much as possible before any sterile gloves are worn before any surgical intervention. It is a cheap and easy method to prevent infections. Effective use of surgical hand scrubbing has an important role in preventing and reducing the transfer of health-related infections. Although many studies have been performed on surgical hand scrubbing, no standard practice has been found in the method of scrubbing and optimal duration of scrubbing time. The aim of this study is to compare evidence-based surgical hand scrubbing methods in order to prevent surgical site infections.

Methods H0: There is no difference between the effectiveness of different surgical hand scrubbing methods on the bacterial flora in the hand H1: There is a difference between the effectiveness of different surgical hand scrubbing methods on the bacterial flora in the hand.

Read more

Time H0: There is no difference between the effectiveness of different the duration of scrubbing time on the bacterial flora in the hand.

H1: There is a difference between the effectiveness of different the duration of scrubbing time on the bacterial flora in the hand.

Read the detailed description

Original Value: Surgical site infections (SSI) are a serious problem due to increased morbidity and mortality, prolonged hospitalization, hospitalization and consumption of health resources. It is reported from guides that the several factors like hair removal, skin antisepsis, prevention of hypothermia, antimicrobial prophylaxis, providing adequate oxygenation applied in intraoperative period reduce SSI. In addition to these factors, it is known that hand antisepsis of the surgical team is one of the most important factors in preventing SSI. Surgical hand scrubbing is the removal of transient flora and reduction of permanent flora as much as possible before any sterile gloves are worn before any surgical intervention. It is a cheap and easy method to prevent infections. Effective use of surgical hand scrubbing has an important role in preventing and reducing the transfer of health-related infections. Therefore, the research topic is directly related to patient safety and is considered to be one of the important areas of health services at national and international level in terms of establishing institutional culture in the prevention of surgical site infections. Although many studies have been performed on surgical hand scrubbing, no standard practice has been found in the method of scrubbing and optimal duration of scrubbing time. The aim of this study is to compare evidence-based surgical hand scrubbing methods in order to prevent surgical site infections.

Method: The research is a randomized controlled prospective study. The universe of the research was surgeon and operating room nurses in Gulhane Training and Research Hospital. The sample size is at least 180 people for one-way analysis of variance with G * Power version 3.1.19 software to determine a medium level (0.25) effect size between 4 groups at 0.80 power and 0.05 type I error level calculated (Tsai, 2016). Participants was divided into 4 groups by randomization method.

The participants in the first group performed the surgical hand scrubbing for 1 minute and with using a nail brush.

The participants in the second group performed the surgical hand scrubbing for 1 minute and without using a nail brush.

The participants in the third group performed the surgical hand scrubbing for 2 minute and with using a nail brush.

The participants in the fourth group performed the surgical hand scrubbing for 2 minute and without using a nail brush.

Standard Practices in All Groups

  • The application will take place during the first surgeries entered in the morning.
  • All groups will be used hand antiseptic (4% Chlorhexidine gluconate) which is used in the operating room.
  • It will be examined whether the nails are smaller than 2 mm. If the nails are long, individuals will be asked to cut their nails with the help of disposable nail scissors before surgical hand scrubbing.
  • There will be no nail polish on the nails and there will be no jewelry on the hand and the ring.
  • 3 ml of antiseptic solution will be used at each washing stage.

Volunteers' Exclusion Criteria (Different from Exclusion Criteria):

  • Participants want to leave the research
  • Expected surgery time is less than 1,5 hours.
  • A tear / puncture in the glove during the operation.
  • During the operation, data collection will be terminated in cases where the sterility of the glove is impaired.

This research will take place in three stages. At all stages (before surgical hand scrubbing, immediately after and at the end of the surgery), culture will be taken from the active hands of the participants with the Glove Juice Method. At all stages, culture will be taken from the participants via Glove Juice Method.

Glove Juice Method It is a method used to determine the number of bacteria on hand. In this method, individuals will be provided to wear gloves on their dominant hand. Powder-free sterile gloves were used for all sampling. Then, 50 ml of 'Tryptic Soy Broth' medium was placed inside the glove and all surfaces of the gloved hand were massaged for 60 seconds by the researcher. A sample was taken from the liquid in the glove using aseptic techniques and analyzed.

Applications in Medical Microbiology Laboratory Before surgical hand scrubbing, samples taken with glove liquid technique were diluted 1:10 in Müller Hinton Broth broth in the laboratory (500 μl sample, 4.5 ml. Müeller Hinton Broth). And 300 μl of it was placed on 5% sheep blood agar plates with sterile micropipettes. 1 ml each of the other samples (after surgical hand scrubbing and at the end of the surgery) was spread diluted into three 5 % sheep blood agar plates with sterile micropipettes. All samples were incubated at 35° C for 48 hours under atmospheric conditions. Total bacterial load was determined by counting the total colony forming units (CFU) on the plates.

Statistical Method SPSS (Statistical Package for the Social Sciences) Windows Version 22.00 package program will be used in the statistical analysis of the data obtained at the end of the study. Number,%, mean ± standard deviation, median (25% -75%) values will be used in defining the data. Kolmogorov-Smirnov test will be used to evaluate the suitability for normal distribution. In comparative statistics, appropriate tests will be used according to the normal distribution of the sample. In statistical decisions, p ≤ 0.05 level will be accepted as an indicator of significant difference.

Being tested
Using a brush
Keywords
scrubbing, scrubbing time, bacterial flora, nursing
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using a brushOther

    Surgical hand scrubbing will be performed in 1 minute and 2 minutes using a disposable nail brush.

Study groups in NCT04579705
Study groupRoleWhat they receive
Group I (Brushed-1 minute)ExperimentalSurgical hand scrubbing will be performed in 1 minute using a brush.
Receives: Other: Using a brush
Group II (Brushless-1 minute)No interventionSurgical hand scrubbing will be performed in 1 minute without using a brush.
Group III (Brushed-2 minutes)ExperimentalSurgical hand scrubbing will be performed in 2 minute using a brush.
Receives: Other: Using a brush
Group IV (Brushless-2 minutes)No interventionSurgical hand scrubbing will be performed in 2 minute without using a brush.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of bacteria on hand

    The effect of brush usage and time on bacterial flora in hand during surgical hand. Bacterial analysis was carried out in three consecutive measurement.

    Measured: ''just before surgical hand scrubbing''

  2. The number of bacteria on hand

    The effect of brush usage and time on bacterial flora in hand during surgical hand scrubbing

    Measured: 'immediately after surgical hand scrubbing''

  3. The number of bacteria on hand

    The effect of brush usage and time on bacterial flora in hand during surgical hand scrubbing

    Measured: ''after surgery (between 90-120 minutes after surgical hand scrubbing)''

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start5 Nov 2019
  3. Primary completion9 Mar 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579705
Sponsor's protocol ID
13131313
Status last verified
Oct 2020
First submitted
21 Sep 2020
Last updated
8 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parlak EA, Iyigun E, Albay A, Bedir O. Impact of methods and duration of surgical hand scrub on bacterial count: A randomized controlled trial. Am J Infect Control. 2021 Nov;49(11):1376-1383. doi: 10.1016/j.ajic.2021.05.006. Epub 2021 May 23.

    PubMed 34029650

Questions about this trial

What is this clinical trial studying?

A study testing Using a brush in people with Surgical Scrubbing and Surgical Site Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of bacteria on hand (time frame: ''just before surgical hand scrubbing''). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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