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

NCT05276687 | Unknown Phase 4

• 1 other identifier: diluted betadine vs antibiotic
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Infection control and health-care-associated infections and Safety of medical service providers
2. 2.Evidence based management of common medical and surgical problems

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (2)

• Superficial wound infection

  Within 20 days

• Deep wound infection

  Within 20 days

Secondary Outcomes (1)

• Healing of sternum ( within 2 months)

  20 days to 60 days

Study Arms (3)

Diluted betadine

EXPERIMENTAL

Drug: Betadine

Powdered vancomycin

EXPERIMENTAL

Drug: Vancomycin

No intervention

NO INTERVENTION

Interventions

Betadine DRUG

Wound irrigation

Diluted betadine

Vancomycin DRUG

instillation in the wound

Powdered vancomycin

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diabetic patients

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 26557476 BACKGROUND

• 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.

  PMID: 22294940 BACKGROUND

• 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.

  PMID: 30069187 BACKGROUND

• 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.

  PMID: 33341848 BACKGROUND

• 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.

  PMID: 31516971 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Abdelrahman Hamed Ahmed

CONTACT

00201060048430; Abdelrahman.hamed.ed@gmail.com

Arwa Salah

CONTACT

00201156748809; arwaabdelaziz54@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 11, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 11, 2022

Record last verified: 2022-03