UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049470 |
|---|---|
| Receipt number | R000056326 |
| Scientific Title | Efficacy of Surgicel Powder for prevention of hematoma after septoplasty. Randomized controlled trial. |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/11/12 18:46:48 |
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Basic information
Public title
Efficacy of Surgicel Powder for prevention of hematoma after septoplasty. Randomized controlled trial.
Acronym
Investigation of the preventive effect of Surgicel Powder on nasal septal hematoma. Randomized controlled trial.
Scientific Title
Efficacy of Surgicel Powder for prevention of hematoma after septoplasty. Randomized controlled trial.
Scientific Title:Acronym
Investigation of the preventive effect of Surgicel Powder on nasal septal hematoma. Randomized controlled trial.
Region
| Japan |
Condition
Condition
nasal septal disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Surgicel Powder in preventing hematoma after nasal septal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of nasal septal hematoma Postoperative pain, bleeding Stress of postoperative procedures
Evaluate from 1 day to 3 months postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group applying Surgicel powder for mucous membrane fixation after nasal septum surgery
Interventions/Control_2
Group of suture fixation of mucosa after nasal septum surgery with silicone plate
Interventions/Control_3
Group of mucosa fixation after nasal septum surgery with absorbable sutures
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing nasal septal surgery
Key exclusion criteria
Anticoagulant medication
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Hosokawa |
Organization
Saitama medical university hospital
Division name
Otorhinolaryngology
Zip code
3500495
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492761111
hosokawa.yu@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Hosokawa |
Organization
Saitama medical university hospital
Division name
Otorhinolaryngology
Zip code
3500495
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492761111
Homepage URL
hosokawa.yu@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university hospital IRB
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
Tel
0492761111
hirb@saitama-med.ac.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
| 2023 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056326
