INFECTION
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVancomycin
Topical prophylactic antibiotic
OTHERNo Vancomycin
Placebo: Sterile water. No Vancomycin.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to sign Informed Consent and Release of Medical Information Form * Age ≥ 18 years * Undergoing cardiac surgery with complete sternotomy (including re-operations)
Exclusion criteria
* Evidence of active infection (any culture positive or blood positive infection) * Undergoing organ transplantation * Patients with known hypersensitivity to vancomycin * Pregnant or nursing women * Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sternal Wound Infections | 3 months postoperative | The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sternal Wound Infections | 1 year postoperative | The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. |
| Hospitalization | 1 year postoperative | Duration of index hospitalization and subsequent re-admissions due to sternal wound infection. |
| Number of Participants With Use of Prophylactic Antibiotics | Assessed before surgery | Number of participants with use of prophylactic antibiotics before surgery |
| Cost Analysis for Sternal Wound Infection Treatment | 1 year postoperative | Cost analysis for sternal wound infection treatment post-operatively |
| Adverse Events | 1 year postoperative | Adverse events during study participation |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 512 |
| 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. | 509 |
| Total | 1,021 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgery Cancelled | 5 | 11 |
Baseline characteristics
| Characteristic | Vancomycin | Control | Total |
|---|---|---|---|
| Age, Continuous | 63.61 years STANDARD_DEVIATION 12.77 | 62.71 years STANDARD_DEVIATION 13.49 | 63.16 years STANDARD_DEVIATION 13.13 |
| Body Mass Index (BMI) | 29.9 kg^m2 STANDARD_DEVIATION 5.8 | 30.1 kg^m2 STANDARD_DEVIATION 5.7 | 30.0 kg^m2 STANDARD_DEVIATION 5.8 |
| Body Surface Area (BSA) | 2.1 m2 STANDARD_DEVIATION 0.3 | 2.1 m2 STANDARD_DEVIATION 0.3 | 2.1 m2 STANDARD_DEVIATION 0.3 |
| Diabetes Mellitus | 167 Participants | 157 Participants | 324 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 512 Participants | 509 Participants | 1021 Participants |
| Sex: Female, Male Female | 116 Participants | 109 Participants | 225 Participants |
| Sex: Female, Male Male | 396 Participants | 400 Participants | 796 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 512 | 0 / 509 |
| other Total, other adverse events | 0 / 512 | 0 / 509 |
| serious Total, serious adverse events | 0 / 512 | 0 / 509 |
Outcome results
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.
Time frame: 3 months postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vancomycin | Number of Sternal Wound Infections | 14 number of infections |
| Control | Number of Sternal Wound Infections | 21 number of infections |
p-value: 0.23Fisher Exact
Secondary
Adverse Events
Adverse events during study participation
Time frame: 1 year postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vancomycin | Adverse Events | 0 number of adverse events |
| Control | Adverse Events | 0 number of adverse events |
Secondary
Cost Analysis for Sternal Wound Infection Treatment
Cost analysis for sternal wound infection treatment post-operatively
Time frame: 1 year postoperative
Population: Data were not collected.
Secondary
Hospitalization
Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
Time frame: 1 year postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vancomycin | Hospitalization | 9.4 days | Standard Deviation 9 |
| Control | Hospitalization | 8.7 days | Standard Deviation 7 |
p-value: 0.054Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Use of Prophylactic Antibiotics
Number of participants with use of prophylactic antibiotics before surgery
Time frame: Assessed before surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vancomycin | Number of Participants With Use of Prophylactic Antibiotics | 512 Participants |
| Control | Number of Participants With Use of Prophylactic Antibiotics | 509 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.
Time frame: 1 year postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vancomycin | Number of Sternal Wound Infections | 15 number of infections |
| Control | Number of Sternal Wound Infections | 22 number of infections |
p-value: 0.25Fisher Exact