NCT04579705

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 21, 2020

Last Update Submit

October 5, 2020

Conditions

Surgical ScrubbingSurgical Site Infection

Keywords

scrubbingscrubbing timebacterial floranursing

Outcome Measures

Primary Outcomes (3)

  • 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.

    ''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

    '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

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

Study Arms (4)

Group I (Brushed-1 minute)

EXPERIMENTAL

Surgical hand scrubbing will be performed in 1 minute using a brush.

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.

Other: Using a brush

Group IV (Brushless-2 minutes)

NO INTERVENTION

Surgical hand scrubbing will be performed in 2 minute without using a brush.

Interventions

Using a brushOTHER

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

Group I (Brushed-1 minute)Group III (Brushed-2 minutes)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 34029650DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is the blind that makes microbiological and statistical analysis
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2020

First Posted

October 8, 2020

Study Start

November 5, 2019

Primary Completion

March 9, 2020

Study Completion

April 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)