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).
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
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.
- Conditions
- Surgical Scrubbing, Surgical Site Infection
- 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 group | Role | What they receive |
|---|---|---|
| Group I (Brushed-1 minute) | Experimental | Surgical hand scrubbing will be performed in 1 minute using a brush. Receives: Other: Using a brush |
| Group II (Brushless-1 minute) | No intervention | Surgical hand scrubbing will be performed in 1 minute without using a brush. |
| Group III (Brushed-2 minutes) | Experimental | Surgical hand scrubbing will be performed in 2 minute using a brush. Receives: Other: Using a brush |
| Group IV (Brushless-2 minutes) | No intervention | Surgical 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.
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''
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''
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.
- First posted8 Oct 2020
- Study start5 Nov 2019
- Primary completion9 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical ScrubbingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Arici Parlak, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Surgical Hand Scrubbing Methods and the Duration of Scrubbing Time on the Bacterial Flora
- ClinicalTrials.gov ID
- NCT04579705
- Acronym / sponsor ID
- 13131313
- Conditions
- Surgical Scrubbing, Surgical Site Infection
- Keywords
- scrubbing, scrubbing time, bacterial flora, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (Brushed-1 minute) | Experimental | Other: Using a brushSurgical hand scrubbing will be performed in 1 minute using a brush. |
| Group II (Brushless-1 minute) | No intervention | –Surgical hand scrubbing will be performed in 1 minute without using a brush. |
| Group III (Brushed-2 minutes) | Experimental | Other: Using a brushSurgical hand scrubbing will be performed in 2 minute using a brush. |
| Group IV (Brushless-2 minutes) | No intervention | –Surgical hand scrubbing will be performed in 2 minute without using a brush. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a surgeon or operating room nurse
- Having six months and more surgical experience
- Agree to participate in the research
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using a brushSurgical hand scrubbing will be performed in 1 minute and 2 minutes using a disposable nail brush. | Other | Group I (Brushed-1 minute), Group III (Brushed-2 minutes) |
Primary outcome
The number of bacteria on hand
Time frame: ''just before surgical hand scrubbing''
The effect of brush usage and time on bacterial flora in hand during surgical hand. Bacterial analysis was carried out in three consecutive measurement.
The number of bacteria on hand
Time frame: 'immediately after surgical hand scrubbing''
The effect of brush usage and time on bacterial flora in hand during surgical hand scrubbing
The number of bacteria on hand
Time frame: ''after surgery (between 90-120 minutes after surgical hand scrubbing)''
The effect of brush usage and time on bacterial flora in hand during surgical hand scrubbing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34029650Parlak 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.