UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062729 |
|---|---|
| Receipt number | R000071826 |
| Scientific Title | Sustained Antimicrobial Efficacy of Silver-Ion/Hydrogen Peroxide versus Quaternary Ammonium on High-Touch Operating Room Surfaces: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 21:09:06 |
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Basic information
Public title
Sustained Antimicrobial Efficacy of Silver-Ion/Hydrogen Peroxide versus Quaternary Ammonium on High-Touch Operating Room Surfaces: A Multicenter Randomized Controlled Trial
Acronym
HP-Ag vs QAC OR Trial
Scientific Title
Sustained Antimicrobial Efficacy of Silver-Ion/Hydrogen Peroxide versus Quaternary Ammonium on High-Touch Operating Room Surfaces: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
HP-Ag vs QAC OR Trial
Region
| Asia(except Japan) |
Condition
Condition
Microbial contamination of high-touch operating room surfaces
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the immediate and sustained antimicrobial efficacy of hydrogen peroxide stabilized with silver ions (HP-Ag) versus quaternary ammonium compounds (QACs) on high-touch operating room surfaces, and secondarily to explore their association with 30-day postoperative surgical site infection rates.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Surface recontamination rate at 4 hours after disinfection (T3), defined as any detectable bacterial growth (>0 CFU/mL) on predefined high-touch operating room surfaces following complete microbial elimination immediately after disinfection (T1).
Key secondary outcomes
1. Microbial burden on predefined high-touch operating room surfaces, measured as CFU/mL immediately after disinfection (T1), 2 hours after disinfection (T2), and 4 hours after disinfection (T3).
2. Surface recontamination rate at 2 hours after disinfection (T2), defined as any detectable bacterial growth (>0 CFU/mL).
3. Incidence of postoperative surgical site infection within 30 days after surgery, assessed according to CDC criteria.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Hydrogen peroxide stabilized with silver ions (HP-Ag): High-touch operating room surfaces were pre-cleaned using disposable detergent-impregnated wipes and then disinfected with a ready-to-use 2% hydrogen peroxide solution stabilized with 10 ppm silver ions. The disinfectant was applied using sterile microfiber towels in a standardized S-shaped wiping pattern with a minimum wet contact time of 1 minute. One disinfection session was performed for each randomized operating room, followed by environmental monitoring for 4 hours.
Interventions/Control_2
Quaternary ammonium compound (QAC): High-touch operating room surfaces were pre-cleaned using disposable detergent-impregnated wipes and then disinfected with a hospital-grade quaternary ammonium compound containing alkyl dimethyl benzyl ammonium chloride (ADBAC) and didecyl dimethyl ammonium chloride (DDAC) at an in-use concentration of 400 ppm. The disinfectant was applied using sterile microfiber towels in a standardized S-shaped wiping pattern with a minimum wet contact time of 1 minute. One disinfection session was performed for each randomized operating room, followed by environmental monitoring for 4 hours.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult patients aged 18 years or older.
2. Undergoing elective, clean surgical procedures in randomized operating rooms.
3. Eligible procedures: laparoscopic cholecystectomy, mesh inguinal hernia repair, umbilical hernia repair, small ventral hernia repair, non-perforated laparoscopic appendectomy, or thyroidectomy.
4. ASA physical status I or II.
5. Operative duration strictly between 60 and 120 minutes.
6. Receipt of standardized antimicrobial prophylaxis and standardized skin antisepsis.
Key exclusion criteria
1. Contaminated surgical wound.
2. Emergency surgery.
3. Active systemic or localized infection.
4. Immunocompromised status.
5. Uncontrolled diabetes mellitus.
6. Pregnancy.
7. Previous surgical intervention in the same anatomical region.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Seyed Abolfazl |
| Middle name | |
| Last name | Hosseini |
Organization
Golestan University of Medical Sciences
Division name
Department of Surgical Technology, Faculty of Paramedical Sciences
Zip code
4918936316
Address
Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Gorgan-Sari Road, Gorgan, Golestan Province, Iran
TEL
+981732430310
hosseinia1377@gmail.com
Public contact
Name of contact person
| 1st name | Seyed Abolfazl |
| Middle name | |
| Last name | Hosseini |
Organization
Golestan University of Medical Sciences
Division name
Department of Surgical Technology, Faculty of Paramedical Sciences
Zip code
4918936316
Address
Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Gorgan-Sari Road, Gorgan,
TEL
+981732430310
Homepage URL
https://goums.ac.ir/
hosseinia1377@gmail.com
Sponsor or person
Institute
Birjand University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Self-funded by the investigators
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Birjand University of Medical Sciences
Address
Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan, Iran
Tel
+985632395000
public-r@bums.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Four teaching hospitals affiliated with Birjand University of Medical Sciences (Birjand, South Khorasan, Iran)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
400
Results
Fifty operating rooms and 400 patients were analyzed. Both disinfectants achieved complete immediate microbial elimination. At 4 hours, median microbial burden was 0 CFU/mL with HP-Ag versus 20 CFU/mL with QAC (P<0.001). Surface recontamination was 29.3% versus 100% (P<0.001). Thirty-day SSI occurred in 2/200 patients (1.0%) with HP-Ag and 9/200 (4.5%) with QAC (P=0.062).
Results date posted
| 2026 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics were comparable between groups. Mean age was 47.8 +/- 13.2 years in the HP-Ag group and 48.9 +/- 12.6 years in the QAC group. Sex, ASA status, operative time, procedure type, OR temperature, relative humidity, air changes per hour, and baseline microbial burden showed no significant between-group differences.
Participant flow
A total of 50 operating rooms were randomized in a 1:1 ratio to HP-Ag (25 operating rooms) or QAC (25 operating rooms). Each group included 150 predefined high-touch surfaces and 200 surgical patients. All 50 operating rooms and all 400 enrolled patients completed the study, with no post-randomization loss or exclusion.
Adverse events
No intervention-related adverse events were reported. The interventions consisted of environmental surface disinfection and were not directly administered to patients.
Outcome measures
Primary outcome: Surface recontamination rate at 4 hours after disinfection. Recontamination occurred in 44/150 surfaces (29.3%) in the HP-Ag group and 150/150 surfaces (100%) in the QAC group (P<0.001).
Secondary environmental outcomes: Median microbial burden at 2 hours was 0.0 CFU/mL in the HP-Ag group and 5.0 CFU/mL in the QAC group (P<0.001); at 4 hours it was 0.0 and 20.0 CFU/mL, respectively (P<0.001). Recontamination at 2 hours occurred in 10.7% versus 77.3%, respectively (P<0.001).
Secondary clinical outcome: Thirty-day surgical site infection occurred in 1.0% of patients in the HP-Ag group and 4.5% in the QAC group (P=0.062).
Plan to share IPD
No
IPD sharing Plan description
Individual participant data are not planned for public sharing. De-identified data may be considered upon reasonable request to the corresponding author, subject to institutional and ethical approval.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was retrospectively registered after completion of the trial during the journal peer-review process.
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071826
