Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
Primary Purpose
Surgical Wound Infection
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Betadine
Vancomycin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection
Eligibility Criteria
Inclusion Criteria:
- age from 1 to 65 years, primary or redo cases
Exclusion Criteria:
- diabetic patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Diluted betadine
Powdered vancomycin
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Superficial wound infection
Deep wound infection
Secondary Outcome Measures
Healing of sternum ( within 2 months)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05276687
Brief Title
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
Official Title
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Infection control and health-care-associated infections and Safety of medical service providers
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diluted betadine
Arm Type
Experimental
Arm Title
Powdered vancomycin
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Betadine
Intervention Description
Wound irrigation
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
instillation in the wound
Primary Outcome Measure Information:
Title
Superficial wound infection
Time Frame
Within 20 days
Title
Deep wound infection
Time Frame
Within 20 days
Secondary Outcome Measure Information:
Title
Healing of sternum ( within 2 months)
Time Frame
20 days to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age from 1 to 65 years, primary or redo cases
Exclusion Criteria:
diabetic patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman Hamed Ahmed
Phone
00201060048430
Email
Abdelrahman.hamed.ed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arwa Salah
Phone
00201156748809
Email
arwaabdelaziz54@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26557476
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.
Results Reference
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PubMed Identifier
22294940
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.
Results Reference
background
PubMed Identifier
30069187
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.
Results Reference
background
PubMed Identifier
33341848
Citation
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.
Results Reference
background
PubMed Identifier
31516971
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.
Results Reference
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Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
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