Trial Outcomes & Findings for Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection (NCT NCT02020018)

NCT ID: NCT02020018

Last Updated: 2019-11-06

Results Overview

The total number of participants with surgical site infections after cardiac surgery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1869 participants
• Primary outcome timeframe: 30 days post-surgery
• Results posted on: 2019-11-06

Participant Flow

Participant milestones

Measure	Prospective Group Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.	Retrospective Arm Conventional sterile dry wound dressing applied immediately postoperatively.
Overall Study STARTED	272	1597
Overall Study COMPLETED	272	1597
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prospective Group n=272 Participants Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.	Retrospective Arm n=1597 Participants Conventional sterile dry wound dressing applied immediately postoperatively.	Total n=1869 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 12.4 • n=272 Participants	65.7 years STANDARD_DEVIATION 12.4 • n=1597 Participants	64.5 years STANDARD_DEVIATION 12.4 • n=1869 Participants
Sex: Female, Male Female	93 Participants n=272 Participants	518 Participants n=1597 Participants	611 Participants n=1869 Participants
Sex: Female, Male Male	179 Participants n=272 Participants	1079 Participants n=1597 Participants	1258 Participants n=1869 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	272 participants n=272 Participants	1597 participants n=1597 Participants	1869 participants n=1869 Participants

PRIMARY outcome

Timeframe: 30 days post-surgery

The total number of participants with surgical site infections after cardiac surgery.

Outcome measures

Measure	Prospective Group n=272 Participants Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.	Retrospective Arm n=1597 Participants Conventional sterile dry wound dressing applied immediately postoperatively.
Wound Infection After Open Heart Surgery	4 Participants	17 Participants

SECONDARY outcome

Timeframe: 30 days post surgery

Population: Data on reoperation was not collected.

The total number of reoperations required due to infection.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative to discharge

Population: Data for this outcome measure was not collected.

Length of stay was defined as the number of nights spent in the hospital after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Prospective Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Retrospective Arm

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. Hartzell V. Schaff

Mayo Clinic

Phone: 507-255-7066

Email: schaff.hartzell@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place