UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063565 |
|---|---|
| Receipt number | R000064182 |
| Scientific Title | Clinical Evidence for Operating Room Environmental Control and Technical Evaluation of an ISO-Containerized Surgical Unit |
| Date of disclosure of the study information | 2026/11/09 |
| Last modified on | 2026/11/09 13:46:17 |
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Basic information
Public title
Evidence on Operating-Room Environmental Control and Evaluation of an ISO-Containerized Surgical Unit
Acronym
Operating-Room Environmental Control and ISO Surgical Unit Evaluation
Scientific Title
Clinical Evidence for Operating Room Environmental Control and Technical Evaluation of an ISO-Containerized Surgical Unit
Scientific Title:Acronym
Operating-Room Environmental Control and ISO Surgical Unit Evaluation
Region
| Asia(except Japan) |
Condition
Condition
Postoperative surgical-site infection (SSI) and periprosthetic joint infection (PJI). Published evidence on operating-room environmental control and nonclinical measurements of an ISO-containerized surgical unit are evaluated.
Classification by specialty
| Surgery in general | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically evaluate clinical evidence on operating-room environmental conditions, infection prevention, and operative-team performance; conduct exploratory meta-analyses of comparable postoperative infection outcomes; and map the evidence against nonclinical measurements of an existing ISO-containerized surgical unit to assess technical conformity and further validation needs.
Basic objectives2
Others
Basic objectives -Others
Systematic review and meta-analysis of operating-room environmental control, with retrospective nonclinical technical evaluation of an existing prototype.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative surgical-site infection (SSI) under laminar or unidirectional airflow versus comparator ventilation. Events and denominators are extracted by arm according to each source study's definition and follow-up period; crude risk ratios and 95% confidence intervals are pooled using a random-effects model.
Key secondary outcomes
Periprosthetic joint infection (PJI): crude risk ratios using source-study follow-up periods of 1 year or up to 2 years. Narrative assessment of published viable airborne contamination and operative-performance outcomes. Comparison of nonclinical prototype air-change rate, supply-air velocity, 0.5- and 5.0-micrometre particle concentrations, pressure differential, temperature, relative humidity, noise and illuminance against relevant GB50333-2013 criteria under stable conditions.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Original comparative studies in surgical patients reporting postoperative infection in relation to operating-room ventilation, with directly extractable infection events and denominators for comparable exposure groups. Studies of environmental contamination and operative performance are considered separately for narrative synthesis. Prototype evaluation uses existing nonclinical environmental measurements. No new participants are recruited.
Key exclusion criteria
For quantitative infection synthesis: reviews, commentaries, protocols, and purely technical descriptions; studies without surgical patients or postoperative infection events; studies without a comparable ventilation contrast or directly extractable two-arm event table; and duplicate patient cohorts. Environmental or simulated-outcome reports without postoperative infection data are excluded from infection meta-analysis but may inform narrative synthesis.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Xiao |
| Middle name | |
| Last name | Zhou |
Organization
Tongji University Affiliated Shanghai Pulmonary Hospital
Division name
Department of Thoracic Surgery
Zip code
200433
Address
507 Zhengmin Road, Yangpu District, Shanghai 200433, China
TEL
+86-21-65115006
zx_ty68@163.com
Public contact
Name of contact person
| 1st name | Xiao |
| Middle name | |
| Last name | Zhou |
Organization
Tongji University Affiliated Shanghai Pulmonary Hospital
Division name
Department of Thoracic Surgery
Zip code
200433
Address
507 Zhengmin Road, Yangpu District, Shanghai 200433, China
TEL
+86-21-65115006
Homepage URL
zx_ty68@163.com
Sponsor or person
Institute
Tongji University Affiliated Shanghai Pulmonary Hospital
Institute
Department
Personal name
Funding Source
Organization
Tongji University Affiliated Shanghai Pulmonary Hospital Foundation (SKPY2021009)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable: meta-analysis/nonclinical study. Administrative enquiries: Xiao Zhou (principal investigator).
Address
Not applicable
Tel
+86-21-65115006
zx_ty68@163.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
No public protocol URL supplied. This is retrospective registration.
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.69854/jcq.2025.0034
Number of participants that the trial has enrolled
0
Results
Five observational studies: SSI (2,774 operations), crude RR 0.88 (95% CI 0.46-1.67); PJI (8,000 arthroplasties), RR 1.33 (0.70-2.54). All had serious risk of bias. Prototype supply velocity, humidity and noise were outside cited limits. No prototype patient, viable microbial or task-performance outcomes were assessed; clinical suitability remains unverified.
Results date posted
| 2026 | Year | 11 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 12 | Month | 08 | Day |
Baseline Characteristics
No newly enrolled participants. Source studies included vascular surgery, orthopaedic trauma and hip/knee arthroplasty. SSI synthesis included 2,774 operations; PJI synthesis included 8,000 arthroplasties. One existing ISO-containerized prototype was evaluated under nonclinical conditions.
Participant flow
No new recruitment, allocation or participant follow-up. Aggregate data from five published studies were synthesized. Enrolled participants = 0 denotes no direct recruitment. Partial publication refers to the prototype technical component published on 8 December 2025 (doi:10.69854/jcq.2025.0034), not the additional clinical evidence synthesis in the present manuscript.
Adverse events
Not applicable: no new human intervention; patient adverse events were not measured in the prototype evaluation.
Outcome measures
Primary outcome: postoperative SSI. Secondary outcomes: PJI, viable airborne contamination, operative performance and prototype environmental measurements. SSI/PJI definitions and follow-up periods followed source studies; other outcomes were assessed narratively.
Plan to share IPD
Not applicable. No individual participant-level data were collected or generated.
IPD sharing Plan description
The study uses aggregate data from published reports and nonclinical environmental measurements. An individual participant data sharing plan is not applicable.
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 05 | Month | 20 | Day |
Other
Other related information
Retrospective registration of a completed systematic review/meta-analysis with nonclinical prototype evaluation; prospective registration is not claimed. No new recruitment, intervention, participant-level data collection or patient follow-up. PubMed, Web of Science Core Collection and Cochrane Library were searched for publications through 1 May 2025, with reference screening (three databases confirmed by investigator). Comparative surgical studies with extractable two-arm infection events and denominators were eligible. SSI and PJI were pooled separately as crude risk ratios using inverse-variance random-effects meta-analysis (DerSimonian-Laird; normal 95% CIs); Q, tau-squared and I-squared described heterogeneity. Two reviewers used ROBINS-I. Environmental contamination and operative-performance evidence was synthesized narratively. Existing measurements from one ISO-containerized prototype were compared with GB50333-2013. Prototype testing preceded the review; that component was published on 8 December 2025 (doi:10.69854/jcq.2025.0034). Funding: Shanghai Pulmonary Hospital Foundation, SKPY2021009; no funder role in data collection, management, analysis or interpretation. The study-start field refers to review research; last-follow-up refers to review completion (20 May 2025), not patient follow-up. The Date of IRB field records the investigator-reported ethics waiver/no-review determination (1 October 2024), not approval of a new human intervention study.
Management information
Registered date
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064182
