임상연구정보서비스

Search: Search

The effectiveness of negative pressure wound dressing for the wound healing after stoma closure :An prospective, open-label, randomized control study

Status Approved

First Submitted Date

2019/06/13
Registered Date

2019/06/13
Last Updated Date

2019/06/13

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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
Institutional Review Board Address	170, Hyeonchung-ro, Nam-gu, Daegu
Institutional Review Board Telephone	053-624-8352
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
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, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	Yeongnam University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-07-05 ,

5. Source of Monetary / Material Support

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

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
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.

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, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
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	2
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)	* (K00-K93)Diseases of the digestive system (K31.6)Fistula of stomach and duodenum Perseon who has ileostomy or colostomy and plans to perform stoma reversal
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~85Year
	Description a person who plans to perform stoma reversal at Yeungnam Umniversity Medical Center
Exclusion Criteria	Exclude any of the following: ① a person who cannot apply the negative wound therapy dressing due to diseases such as skin allergy. ② a person who cannot express himself due to dementia, mental illness etc. ③ a person whgo disagree with this study
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
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, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

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

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2022. 6
Way of Sharing	Available on Request (sungiry@naver.com)

Move list page Move to top