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 | 2026/01/10 16:48:09 |
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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
https://search.jamas.or.jp/search/do/detail/sidx/13/sid/1
Publication of results
Partially published
Result
URL related to results and publications
https://search.jamas.or.jp/search/do/detail/sidx/13/sid/1
Number of participants that the trial has enrolled
150
Results
Cutibacterium acnes was detected in 92 of 150 shoulders. There were no significant differences in C acnes positivity among groups. Overall bacterial contamination was higher in the olanexidine group. Shorter surgical time and suture exposure time were associated with lower culture positivity. No association was observed between bacterial contamination and rotator cuff retear at 1 year. No symptomatic postoperative infections occurred.
Results date posted
| 2026 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 150 male patients (150 shoulders) who underwent primary arthroscopic rotator cuff repair at our institution between July 2021 and October 2022 were enrolled.
The mean age was 62 years (range, 36 to 84 years), with 93 right and 57 left shoulders.
Patients were randomly allocated into three groups according to the preoperative skin antiseptic used: povidone iodine group (P), alcohol containing povidone iodine group (AP), and olanexidine gluconate group (O), with 50 shoulders in each group.
There were no significant differences among the three groups regarding age, operated side, surgical time, suture exposure time, number of medial anchors, rotator cuff tear size, concomitant subscapularis tears, smoking status, or presence of diabetes.
Participant flow
Between July 2021 and October 2022, 159 male shoulders scheduled for primary arthroscopic rotator cuff repair were assessed for eligibility.
Of these, 9 shoulders were excluded due to no anchor use (n = 2), use of povidone iodine containing drapes (n = 3), allergy to antiseptics (n = 2), and skin disease (atopic dermatitis) (n = 2).
A total of 150 shoulders were finally enrolled and randomly allocated to one of three groups: the povidone iodine group (P), alcohol containing povidone iodine group (AP), or olanexidine gluconate group (O), with 50 shoulders in each group.
All patients received the allocated intervention, and all enrolled shoulders were included in the analysis of the primary outcomes.
Adverse events
No adverse events related to the antiseptics were observed during the study period.
In addition, no serious adverse events, including symptomatic postoperative infections, were reported.
Outcome measures
The primary outcome measure was the rate of positive bacterial cultures obtained from sutures collected during arthroscopic rotator cuff repair, including Cutibacterium acnes and other bacteria.
Secondary outcome measures included:
(1) culture positivity rates by bacterial species,
(2) the association between surgical time and suture exposure time with culture positivity, and
(3) the relationship between bacterial contamination and rotator cuff retear assessed by MRI at 1 year postoperatively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051015
