UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038651 |
|---|---|
| Receipt number | R000044038 |
| Scientific Title | Skin Preparation Prior To Epidural Anesthesia: Chlorhexidine or Povidone Iodine? |
| Date of disclosure of the study information | 2019/12/30 |
| Last modified on | 2019/11/21 11:00:52 |
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Basic information
Public title
Skin Preparation Prior To Epidural Anesthesia: Chlorhexidine or Povidone Iodine?
Acronym
Skin Preparation Prior To Epidural Anesthesia: Chlorhexidine or Povidone Iodine?
Scientific Title
Skin Preparation Prior To Epidural Anesthesia: Chlorhexidine or Povidone Iodine?
Scientific Title:Acronym
Skin Preparation Prior To Epidural Anesthesia: Chlorhexidine or Povidone Iodine?
Region
| Asia(except Japan) |
Condition
Condition
Perioperative anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare 0.5% chlorhexidine and 10% povidone iodine in preventing bacterial colonization of epidural catheters in patients treated at Dr. Sardjito Hospital, Yogyakarta, Indonesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The epidural catheter (3-4 cm) tip culture was examined on the 3rd day after installation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
0.5% chlorhexidine in 70% alcohol for skin preparation before epidural anesthesia
Interventions/Control_2
10% povidone iodine for skin preparation before epidural anesthesia
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
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Adult (18-65) years old
- Physical status of American Society of Anesthesiology (ASA) 1-2
- Having consented to participate in this study
Key exclusion criteria
- Allergy to chlorhexidine and povidone iodine
- Patients with sepsis
- Patients with local infection in the back
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | WIDI |
| Middle name | YULI |
| Last name | HARIANTO |
Organization
FACULTY OF MEDICINE, PUBLIC HEALTH AND NURSING, UNIVERSITAS GADJAH MADA
Division name
ANESTESIOLOGY AND INTENSIVE CARE
Zip code
55281
Address
JALAN FARMAKO, SEKIP UTARA, YOGYAKARTA
TEL
+62-274-548846
widiyuli17@gmail.com
Public contact
Name of contact person
| 1st name | WIDI |
| Middle name | YULI |
| Last name | HARIANTO |
Organization
FACULTY OF MEDICINE, PUBLIC HEALTH AND NURSING, UNIVERSITAS GADJAH MADA
Division name
ANESTESIOLOGY AND INTENSIVE CARE
Zip code
55281
Address
JALAN FARMAKO, SEKIP UTARA, YOGYAKARTA
TEL
+62-274-548846
Homepage URL
dekan.fk@ugm.ac.id
Sponsor or person
Institute
FACULTY OF MEDICINE, PUBLIC HEALTH AND NURSING,UNIVERSITAS GADJAH MADA
Institute
Department
Personal name
Funding Source
Organization
NO FUNDING ORGANIZATION
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
MEDICAL AND HEALTH RESEARCH ETHICS COMMITTEE (MHREC) FACULTY OF MEDICINE GADJAH MADA UNIVERSITY - DR. SARDJITO GENERAL HOSPITAL
Address
Gedung Radiopoetro Lt 2 Sayap Barat, Jalan Farmako, Sekip Utara, Yogyakarta
Tel
+62811-2666-869
mhrec_fmugm@ugm.ac.id
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
| 2019 | Year | 12 | Month | 30 | 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
52
Results
Six cultures of catheter tips yielded microorganisms (table 2). The bacterial species identified were Staphylococcus aureus, Staphylococcus warneri, Staphylococcus haemolyticus, Cronobacter sakazakii and Bacillus.
Results date posted
| 2019 | Year | 11 | Month | 21 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044038
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| Registered date | File name |
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