COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"

Surgical Site Infection Clinical Trial

Official title:

COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757623
• Other study ID #: LahoreGeneralHospital
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: February 2021
• Source: Combined Military Hospital, Pakistan
• Contact: Anum Arif, MBBS FCPS
• Phone: 0342238424
• Email: dranumarif[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Difference in Surgical Site Infection According to Gender and Age Groups
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• Purse string closure of Ileostomy
conventional proceedure

Locations

Country	Name	City	State
Pakistan	Ammad Asim	Karachi
Pakistan	Anum Arif	Lahore	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site infection	surgical site infection was graded according to southampton score grade IV and V	14th post operative day