Back to resultsCOMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
Primary Purpose
Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Purse string closure of Ileostomy
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).
Exclusion Criteria:
- Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations
Sites / Locations
- Anum ArifRecruiting
- Ammad AsimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group B : conventional primary closure
Group A: Purse string closure
Arm Description
allileostomies are reversed with conventional method
the ileostomy reversal circular incision used with stitches of continuous and non-absorbable. The wound of skin was closed by using (Proline No. 1) that leaving 0.5 cm defect on middle in the skin.
Outcomes
Primary Outcome Measures
Surgical Site infection
surgical site infection was graded according to southampton score grade IV and V
Secondary Outcome Measures
Full Information
NCT ID
NCT04757623
First Posted
February 13, 2021
Last Updated
February 13, 2021
Sponsor
Combined Military Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04757623
Brief Title
COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
Official Title
COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2021 (Anticipated)
Primary Completion Date
February 16, 2022 (Anticipated)
Study Completion Date
March 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan
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
The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.
Detailed Description
The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised control trial of two arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B : conventional primary closure
Arm Type
No Intervention
Arm Description
allileostomies are reversed with conventional method
Arm Title
Group A: Purse string closure
Arm Type
Experimental
Arm Description
the ileostomy reversal circular incision used with stitches of continuous and non-absorbable. The wound of skin was closed by using (Proline No. 1) that leaving 0.5 cm defect on middle in the skin.
Intervention Type
Procedure
Intervention Name(s)
Purse string closure of Ileostomy
Intervention Description
conventional proceedure
Primary Outcome Measure Information:
Title
Surgical Site infection
Description
surgical site infection was graded according to southampton score grade IV and V
Time Frame
14th post operative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).
Exclusion Criteria:
Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Arif, MBBS FCPS
Phone
0342238424
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ammad Asim
Phone
03333052892
Email
ammadasim@gmail.com
Facility Information:
Facility Name
Anum Arif
City
Lahore
State/Province
Select A State Or Province
ZIP/Postal Code
0092
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anum Arif
Phone
+923422398424
Email
dranumarif@yahoo.com
Facility Name
Ammad Asim
City
Karachi
ZIP/Postal Code
75050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ammad Asim
Phone
03333052892
12. IPD Sharing Statement
Plan to Share IPD
No
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COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
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