UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044726 |
|---|---|
| Receipt number | R000051015 |
| Scientific Title | Effect of disinfectants on suture contamination in arthroscopic rotator cuff repair: a randomized controlled study |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/04/22 16:16:58 |
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Basic information
Public title
Effect of disinfectants on suture contamination in arthroscopic rotator cuff repair: a randomized controlled study
Acronym
Effect of disinfectants on suture contamination in arthroscopic rotator cuff repair: a randomized controlled study
Scientific Title
Effect of disinfectants on suture contamination in arthroscopic rotator cuff repair: a randomized controlled study
Scientific Title:Acronym
Effect of disinfectants on suture contamination in arthroscopic rotator cuff repair: a randomized controlled study
Region
| Japan |
Condition
Condition
rotator cuff tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to verify the effectiveness of disinfectants by randomly assigning them and examining the bacteria on sutures for rotator cuff repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of Cutibacterium acnes by culture of sutures
Key secondary outcomes
postoperative surgical site infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Disinfect the surgical site with povidone-iodine before surgery
Interventions/Control_2
Disinfect the surgical site with alcohol-containing povidone-iodine before surgery
Interventions/Control_3
Disinfect the surgical site with olanexidine before surgery
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
Key inclusion criteria
Patients undergoing arthroscopic rotator cuff repair for primary repairable rotator cuff tears
Key exclusion criteria
Patients with allergies to alcohol, povidone iodine, and olanexidine
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kamijo |
Organization
Funabashi Orthopaedic Hospital
Division name
Sports Medicine & Joint Center
Zip code
274-0822
Address
1-833 Hasama Funabashi, Chiba
TEL
047-425-5585
hideki_kamijou@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kamijo |
Organization
Funabashi Orthopaedic Hospital
Division name
Sports Medicine & Joint Center
Zip code
274-0822
Address
1-833 Hasama Funabashi, Chiba
TEL
047-425-5585
Homepage URL
hideki_kamijou@yahoo.co.jp
Sponsor or person
Institute
Funabashi Orthopaedic Hospital
Institute
Department
Personal name
Funding Source
Organization
Funabashi Orthopaedic Hospital
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
Funabashi Orthopaedic Hospital
Address
1-833 Hasama Funabashi, Chiba
Tel
047-425-5585
rinri@fff.or.jp
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
| 2021 | Year | 07 | Month | 01 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051015
