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

Not Applicable

• Conditions: Surgical Site Infection; Difference in Surgical Site Infection According to Gender and Age Groups
• Interventions: Procedure: Purse string closure of Ileostomy

• Registration Number: NCT04757623
• Lead Sponsor: Combined Military Hospital, Pakistan

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-13
• Last Update Submitted: 2021-02-13
• Study Start: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17
• Primary Completion: 2022-02-16
• Study Completion: 2022-03-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Purse string closure	Purse string closure of Ileostomy	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.

Primary Outcome Measures

Name	Time	Method
Surgical Site infection	14th post operative day	surgical site infection was graded according to southampton score grade IV and V

Trial Locations

Locations (2)

Anum Arif; 🇵🇰 Lahore, Select A State Or Province, Pakistan

Ammad Asim; 🇵🇰 Karachi, Pakistan