UMIN-CTR Clinical Trial

Basic information
Public title	Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery
Acronym	NOCOTA study
Scientific Title	Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery
Scientific Title:Acronym	NOCOTA study
Region	Japan

Condition
Condition	Clean orthopedic surgeries which required hospitalization
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare the effectiveness of preventive antibiotics within 24 hours and within 24-48 hours after clean orthopedic surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgical site infections, urinary tract infections, respiratory tract infections, or other infections which required the use of antibiotics within 30 days after orthopedic surgery
Key secondary outcomes	other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of prophylactic antibiotics within 24 hours after surgery
Interventions/Control_2	Administration of prophylactic antibiotics within 24-48 hours after surgery
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) aged 20 years or older, 2) hospitalized patients, 3) clean surgery, 4) patient with a good command of Japanese, 5) who were able to give consent on their own or through relatives, 6) who had a primary intention wound closure.
Key exclusion criteria	1) operations involving use of external fixations, 2) amputations, 3) needle biopsies, 4) implant removal, 5) reconstructive surgery involving skin tissue such as flap surgery, 6) patients receiving antibiotic therapy prior to surgery, 7) percutaneous vertebroplasty (balloon kyphoplasty, vertebroplasty, etc.) 8) procedures performed in collaboration with other departments.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Okazaki
Organization	Kanto Rosai Hospital
Division name	Department of orthopedic surgery
Zip code	211-8510
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku , Kawasaki City, Kanagawa Prefecture, Japan
TEL	044-411-3131
Email	okazarov@kantoh.johas.go.jp

Public contact
Name of contact person	1st name Kosei Middle name Last name Nagata
Organization	the University of Tokyo Hospital
Division name	Department of Orthopaedic Surgery and Spinal Surgery
Zip code	112-8655
Address	7-3-1Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL	http://ossi.jp/about/
Email	knagata-tky@umin.ac.jp

Sponsor
Institute	Society for Orthopaedic Surgical Site Infection
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Organization of Occupational Health and Safety Kanto Rosai Hospital
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku , Kawasaki City, Kanagawa Prefecture, Japan
Tel	044-411-3131
Email	ossijapan@gmail.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	東京都立広尾病院（東京都） 関東労災病院（神奈川県） 東京都立駒込病院（東京都） 東京都立多摩総合病院整形外科（東京都） 東京都健康長寿医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Related information
URL releasing protocol	http://ossi.jp/info/
Publication of results	Unpublished

Result
URL related to results and publications	http://ossi.jp/info/
Number of participants that the trial has enrolled	1232
Results	The SSI and HAI rate may be equivalent between Group 24 and Group 48.
Results date posted	2019 Year 08 Month 01 Day
Results Delayed	Delay expected
Results Delay Reason	The statistical analysis will need long time.
Date of the first journal publication of results	2020 Year 08 Month 30 Day
Baseline Characteristics	(1) age more than 20 years; (2) hospitalized patients; (3) patients who underwent clean surgery based on CDC wound classification system; (4) patients with a good command of the Japanese language; (5) patients able to give consent on their own or through relatives; and (6) a primary intention wound closure.
Participant flow	In this study, patients will be divided into two groups of different AMP duration using the institution-by-period cluster allocation system. Patients will not be informed of allocation schedule preoperatively.
Adverse events	Adverse events, including anaphylaxis, will not be observed.
Outcome measures	Patients' background and (1) SSI, (2) UTI, (3) RTI, or (4) other infectious diseases. Secondary outcomes will include the prevalence of diseases (1)-(4), (5)mortality, (6) cardiovascular events observed within 30 days after surgery, (7) prolonged hospitalization for >30 days, and (8) the rate of antibiotic resistance of SSI pathogens.
Plan to share IPD	no
IPD sharing Plan description	no

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2019 Year 10 Month 31 Day
Date trial data considered complete	2019 Year 10 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	The patient registration was terminated on December 31, 2018. Data were fixed around June 30, 2019. In order to evaluate the onset of infection within 30 days after surgery. Data analysis was conducted by the end of March 2020.Submission will be performed by August 2020.

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2022 Year 01 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035321