Trial Outcomes & Findings for Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial) (NCT NCT02374853)

Results Overview

The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1037 participants

Primary outcome timeframe

3 months postoperative

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	517	520
Overall Study COMPLETED	512	509
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Surgery Cancelled	5	11

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.	Total n=1021 Participants Total of all reporting groups
Age, Continuous	63.61 years STANDARD_DEVIATION 12.77 • n=512 Participants	62.71 years STANDARD_DEVIATION 13.49 • n=509 Participants	63.16 years STANDARD_DEVIATION 13.13 • n=1021 Participants
Sex: Female, Male Female	116 Participants n=512 Participants	109 Participants n=509 Participants	225 Participants n=1021 Participants
Sex: Female, Male Male	396 Participants n=512 Participants	400 Participants n=509 Participants	796 Participants n=1021 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	512 Participants n=512 Participants	509 Participants n=509 Participants	1021 Participants n=1021 Participants
Body Mass Index (BMI)	29.9 kg^m2 STANDARD_DEVIATION 5.8 • n=512 Participants	30.1 kg^m2 STANDARD_DEVIATION 5.7 • n=509 Participants	30.0 kg^m2 STANDARD_DEVIATION 5.8 • n=1021 Participants
Body Surface Area (BSA)	2.1 m2 STANDARD_DEVIATION 0.3 • n=512 Participants	2.1 m2 STANDARD_DEVIATION 0.3 • n=509 Participants	2.1 m2 STANDARD_DEVIATION 0.3 • n=1021 Participants
Diabetes Mellitus	167 Participants n=512 Participants	157 Participants n=509 Participants	324 Participants n=1021 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.
Number of Sternal Wound Infections	14 number of infections	21 number of infections

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.
Number of Sternal Wound Infections	15 number of infections	22 number of infections

SECONDARY outcome

Timeframe: 1 year postoperative

Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.

Outcome measures

Outcome measures
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.
Hospitalization	9.4 days Standard Deviation 9.0	8.7 days Standard Deviation 7.0

SECONDARY outcome

Timeframe: Assessed before surgery

Number of participants with use of prophylactic antibiotics before surgery

Outcome measures

Outcome measures
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.
Number of Participants With Use of Prophylactic Antibiotics	512 Participants	509 Participants

SECONDARY outcome

Timeframe: 1 year postoperative

Population: Data were not collected.

Cost analysis for sternal wound infection treatment post-operatively

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year postoperative

Adverse events during study participation

Outcome measures

Outcome measures
Measure	Vancomycin n=512 Participants 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	Control n=509 Participants 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.
Adverse Events	0 number of adverse events	0 number of adverse events

Adverse Events

Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Mullen

University of Alberta

Phone: 780-902-6327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place