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

NCT ID: NCT05276687

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-04-30

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.

Conditions

Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diluted betadine

Group Type: EXPERIMENTAL

Betadine

Intervention Type: DRUG

Wound irrigation

Powdered vancomycin

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

instillation in the wound

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Betadine

Wound irrigation

Intervention Type: DRUG

Vancomycin

instillation in the wound

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• diabetic patients

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Hamed Ahmed

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdelrahman Hamed Ahmed

Role: CONTACT

Abdelrahman.hamed.ed@gmail.com

00201060048430

Arwa Salah

Role: CONTACT

arwaabdelaziz54@gmail.com

00201156748809

References

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.

Reference Type: BACKGROUND

PMID: 26557476 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22294940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30069187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33341848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31516971 (View on PubMed)

Other Identifiers

diluted betadine vs antibiotic

Identifier Type: -

Identifier Source: org_study_id