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

NCT04757623 | Unknown DMC

• 1 other identifier: LahoreGeneralHospital
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Site Infection; Difference in Surgical Site Infection According to Gender and Age Groups

Outcome Measures

Primary Outcomes (1)

• Surgical Site infection

  surgical site infection was graded according to southampton score grade IV and V

  14th post operative day

Study Arms (2)

Group B : conventional primary closure

NO INTERVENTION

allileostomies are reversed with conventional method

Group A: Purse string closure

EXPERIMENTAL

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.

Procedure: Purse string closure of Ileostomy

Interventions

Purse string closure of Ileostomy PROCEDURE

conventional proceedure

Group A: Purse string closure

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead

Study Sites (2)

Anum Arif

Lahore, Select A State Or Province, 0092, Pakistan

RECRUITING

Ammad Asim

Karachi, 75050, Pakistan

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anum Arif, MBBS FCPS

CONTACT

0342238424; dranumarif@yahoo.com

Ammad Asim

CONTACT

03333052892; ammadasim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anum Arif

Model Details: randomised control trial of two arms

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 17, 2021
• Study Start: February 16, 2021
• Primary Completion: February 16, 2022
• Study Completion: March 16, 2022
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)