Not provided
Not provided
Not provided
Not provided
Not provided
the preliminary analysis of study result did not show significant benefit that was anticipate
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.
During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water |
|
| Control | Placebo Comparator | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Topical prophylactic antibiotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sternal Wound Infections | The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sternal Wound Infections | The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | 1 year postoperative |
| Hospitalization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abbas Khani-Hanjani, MD | University of Alberta | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water Vancomycin: Topical prophylactic antibiotic |
| FG001 | Control | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin No Vancomycin: Placebo: Sterile water. No Vancomycin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water Vancomycin: Topical prophylactic antibiotic |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Sternal Wound Infections | The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | Posted | Number | number of infections | 3 months postoperative |
|
Post-operatively, 3 months and 1 year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vancomycin | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water Vancomycin: Topical prophylactic antibiotic |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Mullen | University of Alberta | 780-902-6327 | jmullen@ualberta.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2019 | Aug 17, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No Vancomycin | Other | Placebo: Sterile water. No Vancomycin. |
|
|
Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
| 1 year postoperative |
| Number of Participants With Use of Prophylactic Antibiotics | Number of participants with use of prophylactic antibiotics before surgery | Assessed before surgery |
| Cost Analysis for Sternal Wound Infection Treatment | Cost analysis for sternal wound infection treatment post-operatively | 1 year postoperative |
| Adverse Events | Adverse events during study participation | 1 year postoperative |
| Control |
During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin No Vancomycin: Placebo: Sterile water. No Vancomycin. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg^m2 |
|
| Body Surface Area (BSA) | Mean | Standard Deviation | m2 |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Sternal Wound Infections | The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | Posted | Number | number of infections | 1 year postoperative |
|
|
|
|
| Secondary | Hospitalization | Duration of index hospitalization and subsequent re-admissions due to sternal wound infection. | Posted | Mean | Standard Deviation | days | 1 year postoperative |
|
|
|
|
| Secondary | Number of Participants With Use of Prophylactic Antibiotics | Number of participants with use of prophylactic antibiotics before surgery | Posted | Count of Participants | Participants | Assessed before surgery |
|
|
|
| Secondary | Cost Analysis for Sternal Wound Infection Treatment | Cost analysis for sternal wound infection treatment post-operatively | Data were not collected. | Posted | 1 year postoperative |
|
|
| Secondary | Adverse Events | Adverse events during study participation | Posted | Number | number of adverse events | 1 year postoperative |
|
|
|
| 0 |
| 512 |
| 0 |
| 512 |
| 0 |
| 512 |
| EG001 | Control | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin No Vancomycin: Placebo: Sterile water. No Vancomycin. | 0 | 509 | 0 | 509 | 0 | 509 |
Not provided
Not provided
Not provided
| D000602 |
| Amino Acids, Peptides, and Proteins |