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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05276687
Enrollment
80
Registered
2022-03-11
Start date
2022-09-30
Completion date
2024-04-30
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

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.

Interventions

Wound irrigation

DRUGVancomycin

instillation in the wound

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* diabetic patients

Design outcomes

Primary

MeasureTime frame
Superficial wound infectionWithin 20 days
Deep wound infectionWithin 20 days

Secondary

MeasureTime frame
Healing of sternum ( within 2 months)20 days to 60 days

Contacts

Primary ContactAbdelrahman Hamed Ahmed
Abdelrahman.hamed.ed@gmail.com00201060048430
Backup ContactArwa Salah
arwaabdelaziz54@gmail.com00201156748809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026