Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection

Phase 4

• Conditions: Surgical Wound Infection
• Interventions: Drug: Betadine; Drug: Vancomycin

• Registration Number: NCT05276687
• Lead Sponsor: Assiut University

Brief Summary

1. Infection control and health-care-associated infections and Safety of medical service providers

2. Evidence based management of common medical and surgical problems

Detailed Description

Surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. Superficial sternal wound infection (SSWI) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). Deep sternal wound infection (DSWI) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced DSWI(3). Sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). Although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. Recent clinical practice guidelines from the Centers for Disease Control, World Health Organization, and International Consensus Meeting on Musculoskeletal Infection advocate the use of a dilute povidone-iodine solution prior to wound closure. This experience suggests that this practice is safe, inexpensive, and easily implemented(5). The present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11
• Study Start: 2022-09
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age from 1 to 65 years, primary or redo cases

Exclusion Criteria

• diabetic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diluted betadine	Betadine	-
Powdered vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Superficial wound infection	Within 20 days
Deep wound infection	Within 20 days

Secondary Outcome Measures

Name	Time	Method
Healing of sternum ( within 2 months)	20 days to 60 days