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Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

Primary Purpose

Surgical Site Infection, Surgical Wound, Surgical Incision

Status
Recruiting
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
0.9% saline solution
Povidone-iodine Swab
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi The age of patients should be between 18-60 years old. Exclusion Criteria: Diabetic patients Immune-suppressed patients Patients taking steroids Patients undergoing chemo-radiotherapy. Pregnant females Previous abdominal surgery within the last 30 days. Presence of concurrent abdominal wall infections. Trauma Laparotomies Large Bowel perforations

Sites / Locations

  • Dr. Ruth K. M. Pfau Civil Hospital KarachiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Intra-operative wound irrigation of 0.9% solution saline solution

No intra-operative wound lavage done

Outcomes

Primary Outcome Measures

Incidence of Superficial Surgical site infections
Development of Superficial Surgical Site Infection as determined by the CDC guidelines.

Secondary Outcome Measures

Length of Hospital Stay
Number of in-hospital days (from time of admission to time of discharge)

Full Information

First Posted
July 19, 2023
Last Updated
August 9, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05989386
Brief Title
Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies
Official Title
Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of Intraoperative Incision Wound in Preventing Surgical Site Infections in Emergency Laparotomies: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2023 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
May 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are: Incidence of SSI after intervention Length of hospital stay Participants will be randomly assigned to two groups receiving either of the two groups: Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation. Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Surgical Wound, Surgical Incision, Emergency Laparotomies, Laparotomies, Post Operative Wound Infection, Wound Infection, Seroma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Intra-operative wound irrigation of 0.9% solution saline solution
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
No intra-operative wound lavage done
Intervention Type
Procedure
Intervention Name(s)
0.9% saline solution
Intervention Description
During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.
Intervention Type
Procedure
Intervention Name(s)
Povidone-iodine Swab
Other Intervention Name(s)
Control
Intervention Description
No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.
Primary Outcome Measure Information:
Title
Incidence of Superficial Surgical site infections
Description
Development of Superficial Surgical Site Infection as determined by the CDC guidelines.
Time Frame
Upto 4 weeks post-operatively
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Number of in-hospital days (from time of admission to time of discharge)
Time Frame
Upto 4 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi The age of patients should be between 18-60 years old. Exclusion Criteria: Diabetic patients Immune-suppressed patients Patients taking steroids Patients undergoing chemo-radiotherapy. Pregnant females Previous abdominal surgery within the last 30 days. Presence of concurrent abdominal wall infections. Trauma Laparotomies Large Bowel perforations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Bin Khalid, Assist Prof.
Phone
+92 321 2040064
Email
dromerkhalid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Afeera Ahmed, Undergraduate
Phone
+923352547330
Email
afeeranws@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Bin Khalid, Assist Prof.
Organizational Affiliation
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Imrana Zulfikar, Professor
Organizational Affiliation
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Ruth K. M. Pfau Civil Hospital Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Bin khalid, Asst. Prof
Phone
+92 321 2040064
Email
dromerkhalid@gmail.com
First Name & Middle Initial & Last Name & Degree
Omer Bin Khalid, FCPS-II
First Name & Middle Initial & Last Name & Degree
Afeera Bashir, Undergrad.
First Name & Middle Initial & Last Name & Degree
Azzam Ali, Undergrad.
First Name & Middle Initial & Last Name & Degree
Bushra Saeed Khan, FCPS-I
First Name & Middle Initial & Last Name & Degree
Rabbiyya Ali, FCPS-II
First Name & Middle Initial & Last Name & Degree
Imrana Zulfikar, FCPS-II

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

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