UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053526 |
|---|---|
| Receipt number | R000061049 |
| Scientific Title | A randomized controlled trial of comparing nanotechnology antimicrobial spray versus traditional wound dressing in the treatment of small abscesses in the Accident and Emergency Department |
| Date of disclosure of the study information | 2024/02/03 |
| Last modified on | 2024/02/02 19:56:41 |
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Basic information
Public title
Nanotechnology antimicrobial spray for abscess treatment
Acronym
Nanotechnology antimicrobial spray for abscess treatment
Scientific Title
A randomized controlled trial of comparing nanotechnology antimicrobial spray versus traditional wound dressing in the treatment of small abscesses in the Accident and Emergency Department
Scientific Title:Acronym
A randomized controlled trial of comparing nanotechnology antimicrobial spray versus traditional wound dressing in the treatment of small abscesses in the Accident and Emergency Department
Region
| Asia(except Japan) |
Condition
Condition
Treatment of small abscesses in the Accident and Emergency Department
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study plans to evaluate the use of nanotechnology antibacterial spray versus traditional wound dressing in the treatment of small abscesses in the Accident and Emergency Department.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- Healing time after incision and drainage
Key secondary outcomes
- Pain, on a 10 point Likert-type scales at last follow up
- Patient satisfaction, on a 10 point Likert-type scales at last follow up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Applying traditional wound dressing to wound after incision and drainage of abscess
Interventions/Control_2
Applying nanotechnology spray to wound after incision and drainage of abscess at day 3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Abscesses of sizes 3 cm and below requiring incision and drainage presenting to the Emergency Department
Key exclusion criteria
- Diabetes mellitus
- Peripheral vascular disease
- On oral steroids or other immunosuppressant drug
- Pregnancy
- Tourists
- Language barriers
- Mentally incapacitated
- Abscesses located on the face
- Abscesses located on the perineum
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Siu Kei Sam |
| Middle name | |
| Last name | Hon |
Organization
Hong Kong Hospital Authority
Ruttonjee Hospital
Division name
Accident and Emergency Department
Zip code
0
Address
266 Queen's Road East, Wan Chai, Hong Kong
TEL
+85222912012
skhon1@gmail.com
Public contact
Name of contact person
| 1st name | Siu Kei Sam |
| Middle name | |
| Last name | Hon |
Organization
Hong Kong Hospital Authority, Ruttonjee Hospital
Division name
Accident and Emergency Department
Zip code
0
Address
266 Queen's Road East, Wan Chai, Hong Kong
TEL
+85222912012
Homepage URL
skhon1@gmail.com
Sponsor or person
Institute
Hong Kong East Cluster
Institute
Department
Personal name
Funding Source
Organization
Hong Kong East Cluster Research Ethics Committee
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
Hong Kong East Cluster Research Ethics Committee
Address
3/F Multicenter Block A, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Tel
+85225956111
hkececsec@ha.org.hk
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
Hong Kong Ruttonjee Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 03 | 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
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Results of the study was delayed due to the recent COVID-19 epidemic.
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
| 2018 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061049
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
