Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402531001186 Date of Approval: 15/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Impact of Enhanced Cleaning of the Environmental Surfaces on the Bacterial Contamination at the Intensive Care Units
Official scientific title The Impact of Enhanced Cleaning of the Environmental Surfaces on the Bacterial Contamination at the Intensive Care Units of the Neurosurgery Department in Alexandria Main University Hospital
Brief summary describing the background and objectives of the trial Contaminated environmental surfaces play an important role in the transmission of pathogens that cause hospital-acquired infections. The study aimed at assessing the effect of enhanced cleaning technique on the bacterial contamination at the high-touch areas inside the intensive care units compared to the routine cleaning at the ICU of the neurosurgery department of Alexandria Main University Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied hospital acquired infections
Purpose of the trial Early detection /Screening
Anticipated trial start date 14/09/2020
Actual trial start date 15/12/2020
Anticipated date of last follow up 08/06/2021
Actual Last follow-up date 10/08/2021
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 18
Recruitment status Completed
Publication URL wwwhttps://pactr.samrc.ac.za/Researcher/TrialRegister.aspx
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group applying enhanced cleaning technique on the environmental surfaces 2 sessions per month for 3 months 3 months. We applied educational sessions on the enhanced cleaning technique to the healthcare workers and nurses who were responsible for cleaning and disinfecting the rooms to improve their practices, hoping the environmental bacterial load would decrease to the permissible level. 18
Control Group routine cleaning team no intervention was applied 3 months we did not give any instructions to the healthcare workers or the nurses about cleaning and disinfection. 18 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
healthcare workers "cleaning workers and nurses," who are responsible for cleaning and disinfecting the ICU rooms in the neurosurgical department of faculty of medicine at the Alexandria main university hospital healthcare workers outside the ICU rooms in the neurosurgical department of faculty of medicine Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/09/2023 ethics committtee of high institute of public health alexandria university
Ethics Committee Address
Street address City Postal code Country
165 al horia street. alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We measured the total aerobic bacterial counts (TACC) on the environmental surfaces. after 6 months
Secondary Outcome decrease in the rate of hospital acquired infections in the ICU 6 months before and after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
high insitute of public health al horiya road alexandria 0023 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal loran alexandria 0023 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor investigator loran alexandria 0023 Egypt investigator
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries nermine hamed nermine.hamed@alexu.edu.eg +201225927114 al horia street
City Postal code Country Position/Affiliation
alexandria 21561 Egypt fellow in Alexandria university hospitals
Role Name Email Phone Street address
Scientific Enquiries nermine hamed nermine.hamed@alexu.edu.eg +201225927114 al horia
City Postal code Country Position/Affiliation
alexandria 21561 Egypt fellow in Alexandria university hospitals
Role Name Email Phone Street address
Principal Investigator mohamed hussein hiph-mohamedfakhry@alexu.edu.eg +201271266332 al horia street
City Postal code Country Position/Affiliation
alexandria 21561 Egypt lecturer of public health Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, IPD will be shared. Individual participant data will be available after de-identifying individual trial participant data (text, tables, figures, and appendices). A statistical analysis plan and analytic code will also be available. It will be immediately after publication for the researchers who wish to access the data to achieve the aims of the approved proposal. proposal should be directed to hiph-mohamedfakhry@alexu.edu.eg Study Protocol data will be available just after publication, with no end date all researchers who are interested in the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/file/d/1jxjQ-zagaJrp7y76-z7GWMny-e_a0QKN/view?usp=share_link Yes 09/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information