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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276687
• Other study ID #: diluted betadine vs antibiotic
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Abdelrahman Hamed Ahmed
• Phone: 00201060048430
• Email: Abdelrahman.hamed.ed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• diabetic patients

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• Betadine
Wound irrigation
• Vancomycin
instillation in the wound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Asghar A, Talha KM, Amanullah M, Shahabuddin S. Comparison of figure of eight and traditional simple wire closure method to prevent dehiscence after sternal closure. J Pak Med Assoc. 2020 Nov;70(11):2001-2006. doi: 10.5455/JPMA.20135. — View Citation

Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4. — View Citation

Goswami K, Austin MS. Intraoperative povidone-iodine irrigation for infection prevention. Arthroplast Today. 2019 May 22;5(3):306-308. doi: 10.1016/j.artd.2019.04.004. eCollection 2019 Sep. — View Citation

Kotnis-Gaska A, Mazur P, Olechowska-Jarzab A, Stanisz A, Bulanda M, Undas A. Sternal wound infections following cardiac surgery and their management: a single-centre study from the years 2016-2017. Kardiochir Torakochirurgia Pol. 2018 Jun;15(2):79-85. doi: 10.5114/kitp.2018.76472. Epub 2018 Jun 25. — View Citation

Singh K, Anderson E, Harper JG. Overview and management of sternal wound infection. Semin Plast Surg. 2011 Feb;25(1):25-33. doi: 10.1055/s-0031-1275168. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superficial wound infection		Within 20 days
Primary	Deep wound infection		Within 20 days
Secondary	Healing of sternum ( within 2 months)		20 days to 60 days