Back to resultsPrimary Versus Secondary Closure of Stoma-Reversal Skin Wound
Primary Purpose
Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
primary skin closure
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infection focused on measuring skin closure, stoma reversal
Eligibility Criteria
Inclusion Criteria:
- . All patients who undergo ileostomy or colostomy reversal will be included
Exclusion Criteria:
- included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
Sites / Locations
- Ayub teaching hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
primary skin closure
secondary skin closure
Arm Description
in this group, skin wound will be primarily closed
skin will be left open to heal by secondary intention
Outcomes
Primary Outcome Measures
surgical site infection
skin wound infection at surgical site will be observed on CDC guidelines
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785404
Brief Title
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound
Official Title
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ayub Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to compare infection rate stoma reversal skin wound after primary or secondary closure
Detailed Description
There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
skin closure, stoma reversal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients will be randomly distributed to two groups. Group A patients will have skin wounds stithed after stoma reversal while in secondary closure group B, wound will be allowed to heal by secondary intention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
primary skin closure
Arm Type
Experimental
Arm Description
in this group, skin wound will be primarily closed
Arm Title
secondary skin closure
Arm Type
No Intervention
Arm Description
skin will be left open to heal by secondary intention
Intervention Type
Procedure
Intervention Name(s)
primary skin closure
Intervention Description
skin will be stitched after stoma reversal to heal by primary intention
Primary Outcome Measure Information:
Title
surgical site infection
Description
skin wound infection at surgical site will be observed on CDC guidelines
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. All patients who undergo ileostomy or colostomy reversal will be included
Exclusion Criteria:
included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zanib Javed, FCPS
Organizational Affiliation
Ayub Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayub teaching hospital
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22040
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
will be shared after publication
IPD Sharing Time Frame
after publication
IPD Sharing Access Criteria
request will be reviewed by the investigators and and further decision regarding access will be made.after publication in indexed journal it will be available online
Learn more about this trial
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound
We'll reach out to this number within 24 hrs