Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651268
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Local Application of Vancomycin powder Before Surgical Closure Helps to Reduce Sternal Wound Infection After Cardiac Surgery Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Title The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery A Randomized Controlled Trial
Introduction
Sternal wound infections SWIs are significant complications in cardiac surgery leading to serious issues like mediastinitis prolonged hospital stays and higher healthcare costs This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics
Objectives
To assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery
To determine its impact on postoperative hospital stays
Study Design and Methodology
A randomized controlled trial will be conducted at Liaquat National Hospital Karachi with 24 patients 12 in each group
Group A will receive standard wound closure while Group B will receive vancomycin powder applied to the sternal wound
Postoperative wound assessments will be conducted at 48 hours 7 days and 1 month
Ethical Considerations
Ethical approval will be obtained and informed consent will be sought from all participants
Introduction
Sternal wound infections SWIs are significant complications in cardiac surgery leading to serious issues like mediastinitis prolonged hospital stays and higher healthcare costs This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics
Objectives
To assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery
To determine its impact on postoperative hospital stays
Study Design and Methodology
A randomized controlled trial will be conducted at Liaquat National Hospital Karachi with 24 patients 12 in each group
Group A will receive standard wound closure while Group B will receive vancomycin powder applied to the sternal wound
Postoperative wound assessments will be conducted at 48 hours 7 days and 1 month
Ethical Considerations
Ethical approval will be obtained and informed consent will be sought from all participants
Detailed Description:
Title The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery A Randomized Controlled Trial
Introduction
Surgical site infections SSIs particularly sternal wound infections SWIs represent a significant complication in cardiac surgeries contributing to increased morbidity including deep infections like mediastinitis extended hospital stays and higher healthcare costs Current preventive measures primarily the use of systemic antibiotics have not been fully effective in minimizing these risks Vancomycin powder a topical glycopeptide antibiotic with activity against Gram-positive bacteria has been proposed as an adjunct to systemic antibiotic therapy to further reduce the incidence of SWIs This study aims to evaluate the role of vancomycin powder in reducing the incidence of SWIs and its subsequent impact on patient outcomes including the length of postoperative hospital stays
Study Design
This study is a randomized controlled trial RCT designed to assess the effectiveness of vancomycin powder in preventing sternal wound infections following cardiac surgery The study will be conducted at the Department of Cardiothoracic Surgery Liaquat National Hospital Karachi over a period of six months from the date of study approval The trial will involve 24 adult patients undergoing elective cardiac surgeries such as coronary artery bypass graft CABG or valve replacement surgeries
Objective
The primary objective of this study is to evaluate the efficacy of vancomycin powder in reducing the rate of sternal wound infections in patients undergoing cardiac surgery The secondary objective is to assess the impact of vancomycin powder application on the length of postoperative hospital stay
Study Methodology
Sample Size The sample size consists of 24 patients divided into two groups of 12 each
Randomization Patients will be randomly allocated to one of the two groups
Group A Control Standard wound closure without the use of vancomycin powder Group B Intervention Application of 1g vancomycin powder to the sternal wound before closure in addition to standard wound closure techniques
Outcome Measures
Primary Outcome Incidence of sternal wound infections at 48 hours 7 days and 1 month postoperatively
Secondary Outcome Length of postoperative hospital stay in days
Data Collection and Monitoring
Wound Assessment A structured wound assessment will be conducted postoperatively at 48 hours 7 days and 1 month to monitor for signs of infection
Infection Diagnosis SWIs will be diagnosed based on clinical signs eg redness discharge pain and supported by microbiological evidence if infection is suspected
Hospital Stay The total length of the patients hospital stay will be recorded to assess the secondary outcome of the trial
Ethical Considerations
Ethical approval will be obtained from the institutional review board IRB before initiating the study Informed consent will be obtained from all participants after they are provided with detailed information about the study its objectives risks and potential benefits Patient confidentiality will be maintained throughout the study and no personal identifiers will be disclosed in any publications
Safety and Adverse Events
Given the administration of vancomycin powder the study will closely monitor for potential adverse events such as allergic reactions or vancomycin-induced toxicity Any serious adverse events SAEs will be promptly reported to the IRB and appropriate measures including discontinuation of vancomycin or medical management will be initiated if necessary In the event of any SAE compensation for participants will be provided in accordance with institutional guidelines
Budget and Consent Forms
The detailed budget for the study and the consent forms will be shared separately to ensure financial transparency and appropriate patient consent processes
Introduction
Surgical site infections SSIs particularly sternal wound infections SWIs represent a significant complication in cardiac surgeries contributing to increased morbidity including deep infections like mediastinitis extended hospital stays and higher healthcare costs Current preventive measures primarily the use of systemic antibiotics have not been fully effective in minimizing these risks Vancomycin powder a topical glycopeptide antibiotic with activity against Gram-positive bacteria has been proposed as an adjunct to systemic antibiotic therapy to further reduce the incidence of SWIs This study aims to evaluate the role of vancomycin powder in reducing the incidence of SWIs and its subsequent impact on patient outcomes including the length of postoperative hospital stays
Study Design
This study is a randomized controlled trial RCT designed to assess the effectiveness of vancomycin powder in preventing sternal wound infections following cardiac surgery The study will be conducted at the Department of Cardiothoracic Surgery Liaquat National Hospital Karachi over a period of six months from the date of study approval The trial will involve 24 adult patients undergoing elective cardiac surgeries such as coronary artery bypass graft CABG or valve replacement surgeries
Objective
The primary objective of this study is to evaluate the efficacy of vancomycin powder in reducing the rate of sternal wound infections in patients undergoing cardiac surgery The secondary objective is to assess the impact of vancomycin powder application on the length of postoperative hospital stay
Study Methodology
Sample Size The sample size consists of 24 patients divided into two groups of 12 each
Randomization Patients will be randomly allocated to one of the two groups
Group A Control Standard wound closure without the use of vancomycin powder Group B Intervention Application of 1g vancomycin powder to the sternal wound before closure in addition to standard wound closure techniques
Outcome Measures
Primary Outcome Incidence of sternal wound infections at 48 hours 7 days and 1 month postoperatively
Secondary Outcome Length of postoperative hospital stay in days
Data Collection and Monitoring
Wound Assessment A structured wound assessment will be conducted postoperatively at 48 hours 7 days and 1 month to monitor for signs of infection
Infection Diagnosis SWIs will be diagnosed based on clinical signs eg redness discharge pain and supported by microbiological evidence if infection is suspected
Hospital Stay The total length of the patients hospital stay will be recorded to assess the secondary outcome of the trial
Ethical Considerations
Ethical approval will be obtained from the institutional review board IRB before initiating the study Informed consent will be obtained from all participants after they are provided with detailed information about the study its objectives risks and potential benefits Patient confidentiality will be maintained throughout the study and no personal identifiers will be disclosed in any publications
Safety and Adverse Events
Given the administration of vancomycin powder the study will closely monitor for potential adverse events such as allergic reactions or vancomycin-induced toxicity Any serious adverse events SAEs will be promptly reported to the IRB and appropriate measures including discontinuation of vancomycin or medical management will be initiated if necessary In the event of any SAE compensation for participants will be provided in accordance with institutional guidelines
Budget and Consent Forms
The detailed budget for the study and the consent forms will be shared separately to ensure financial transparency and appropriate patient consent processes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None