UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060219 |
|---|---|
| Receipt number | R000068876 |
| Scientific Title | A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/27 22:08:09 |
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Basic information
Public title
A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery
Acronym
SPARC study
Scientific Title
A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery
Scientific Title:Acronym
SPARC study
Region
| Japan |
Condition
Condition
rotator cuff tear and recurrent shoudler dislocation
Classification by specialty
| Orthopedics | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively compare the preventive effects of benzoyl peroxide and hydrogen peroxide used as preoperative skin preparation against Cutibacterium acnes in patients undergoing arthroscopic shoulder surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Culture positivity rate of Cutibacterium acnes in skin specimens collected at the end of surgery
Key secondary outcomes
Culture positivity rate of Cutibacterium acnes in skin specimens collected before surgery and immediately after skin disinfection
Semi-quantitative culture results of Cutibacterium acnes in skin specimens collected before surgery, immediately after skin disinfection, and at the end of surgery
Incidence of skin-related adverse events associated with preoperative skin preparation
Compliance with preoperative skin preparation using benzoyl peroxide
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Standard preoperative skin disinfection using an alcohol-based chlorhexidine solution performed immediately before surgery.
Interventions/Control_2
Benzoyl peroxide is applied to the surgical site once daily on the day before surgery, followed by standard preoperative skin disinfection using an alcohol-based chlorhexidine solution on the day of surgery.
Interventions/Control_3
Skin preparation using hydrogen peroxide is performed on the day of surgery, followed by standard preoperative skin disinfection with an alcohol-based chlorhexidine solution.
Interventions/Control_4
Benzoyl peroxide is applied once daily to the surgical site on the day before surgery. On the day of surgery, skin preparation using hydrogen peroxide is performed, followed by standard preoperative skin disinfection with an alcohol-based chlorhexidine solution.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo arthroscopic shoulder surgery for rotator cuff tear or recurrent shoulder dislocation at our institution
2. Patients who received an explanation of the study and provided written informed consent
Key exclusion criteria
1. Patients with a known allergy or hypersensitivity to benzoyl peroxide or hydrogen peroxide
2. Patients with active skin disorders at the surgical site
3. Patients judged to have markedly poor compliance with preoperative skin preparation using benzoyl peroxide
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
Shoulder & Elbow Service, 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
Self funding
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
| 2026 | Year | 01 | 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
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068876
