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  • Status : Approved
    • First Submitted Date : 2019/06/13
    • Registered Date : 2019/06/13
    • Last Updated Date : 2019/06/13
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1. Background

Background Information
CRIS
Registration Number
KCT0004063 
Unique Protocol ID YUMC 2019-04-031-002 
Public/Brief Title The effectiveness of negative pressure wound dressing for the wound healing after stoma closure 
Scientific Title The effectiveness of negative pressure wound dressing for the wound healing after stoma closure :An prospective, open-label, randomized control study  
Acronym SC-PICO study 
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number YUMC 2019-04-031-002 
Approval Date 2019-06-12 
Institutional Review Board  
Name YUMC IRB 
Address 170, Hyeonchung-ro, Nam-gu, Daegu 
Telephone 053-624-8352 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Sung Il Kang 
Title MD 
Telephone +82-53-620-3580 
Affiliation Yeongnam University Medical Center 
Address Yeungnam University Medical Center, 170, Hyeonchung-ro, Nam-Gu, 42415, Daegu, Korea 
Contact Person for Public Queries
Name Sung Il Kang 
Title MD 
Telephone +82-53-620-3580 
Affiliation Yeongnam University Medical Center 
Address Yeungnam University Medical Center, 170, Hyeonchung-ro, Nam-Gu, 42415, Daegu, Korea 
Contact Person for Updating Information
Name Sung Il Kang 
Title MD 
Telephone +82-53-620-3580 
Affiliation Yeongnam University Medical Center 
Address Yeungnam University Medical Center, 170, Hyeonchung-ro, Nam-Gu, 42415, Daegu, Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2019-07-05 , Anticipated
Target Number of Participant 36
Primary Completion Date 2021-06-30 , Anticipated
Study Completion Date 2021-07-30 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Yeongnam University Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2019-07-05 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Yeongnam University Medical Center 
Organization Type Medical Institute  
Project ID YUMC 2019-04-031-002 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Yeongnam University Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary The wound healing period of the purse-string closure after stoma closure is longer than the primary closure although the purse-string closure reduces wound infection. The application of the negative pressure wound dressing reduced wound healing period in other type of wound. Therefore, this study aimed to compare the healing period between the application and non-application of the negative wound dressing.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Phase4 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type /Procedure/Surgery  
Intervention Description to application of negative pressure wound dressing device or not after purse-string closure of the stoma closure wound  
Number of Arms
Arm 1 Arm Label PICO group 
Target Number of Participant 18 
Arm Type Experimental 
Arm Description to application of negative pressure wound dressing device after purse-string closure of the stoma closure wound 
Arm 2 Arm Label non-PICO group 
Target Number of Participant 18 
Arm Type Active comparator 
Arm Description to application of simple dressing after purse-string closure of the stoma closure wound 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the digestive system
 Perseon who has ileostomy or colostomy and plans to perform stoma reversal
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 85 Year
Description a person who plans to perform stoma reversal at Yeungnam Umniversity Medical Center  
Exclusion Criteria Exclude any of the following: <br /> <br />① a person who cannot apply the negative wound therapy dressing due to diseases such as skin allergy. <br />② a person who cannot express himself due to dementia, mental illness etc. <br />③ a person whgo disagree with this study  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome The complete wound healing period (days). 
Timepoint The day until the wound reaches epithelization and need no more dressing 
Secondary Outcome(s) 1 
Outcome surgical site infection rate 
Timepoint The day until the wound reaches epithelization and need no more dressing 
Secondary Outcome(s) 2 
Outcome Number of wound dressing until the complete wound healing period 
Timepoint The day until the wound reaches epithelization and need no more dressing 
Secondary Outcome(s) 3 
Outcome number of visits to medical institution for wound dressing until the complete wound healing period 
Timepoint The day until the wound reaches epithelization and need no more dressing 
Secondary Outcome(s) 4 
Outcome hospital stay after operation (days) 
Timepoint The day of discharge 
Secondary Outcome(s) 5 
Outcome Patient and observer scar assessment scale (POSAS) 
Timepoint The day until the wound reaches epithelization and need no more dressing 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2022.06
Way of Sharing Available on Request
(sungiry@naver.com)
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