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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05276687
Other study ID # diluted betadine vs antibiotic
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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