An interventional study of Prevena Incision Management System and Conventional sterile dry wound dressing in Surgical Wound Infection, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,869 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
Device: Prevena Incision Management System
Conventional sterile dry wound dressing applied immediately postoperatively.
Other: Conventional sterile dry wound dressing
negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
Also known as: negative pressure therapy, wound VAC, Prevena
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
Also known as: poststernotomy wound dressing, standard dressing after sternotomy
Wound Infection After Open Heart Surgery
The total number of participants with surgical site infections after cardiac surgery.
Time frame: 30 days post-surgery
Reoperation for Wound Infection
The total number of reoperations required due to infection.
Time frame: 30 days post surgery
Length of Stay
Length of stay was defined as the number of nights spent in the hospital after surgery.
Time frame: postoperative to discharge
| Milestone | Prospective Group | Retrospective Arm |
|---|---|---|
| Started | 272 | 1597 |
| Completed | 272 | 1597 |
| Not completed | 0 | 0 |
The total number of participants with surgical site infections after cardiac surgery.
| Participants | Prospective Group | Retrospective Arm |
|---|---|---|
| Wound Infection After Open Heart Surgery | 4 | 17 |
The total number of reoperations required due to infection.
No measurements were reported for this outcome.
Length of stay was defined as the number of nights spent in the hospital after surgery.
No measurements were reported for this outcome.
Collected over Adverse events were collected for 30 days postoperatively.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Group | 0/272 (0%) | 0/272 (0%) | 0/272 (0%) |
| Retrospective Arm | 0/1,597 (0%) | 0/1,597 (0%) | 0/1,597 (0%) |
| Age, Continuous(years) | Prospective Group | Retrospective Arm | Total |
|---|---|---|---|
| Mean | 63.3 ± 12.4 | 65.7 ± 12.4 | 64.5 ± 12.4 |
| Sex: Female, Male(Participants) | Prospective Group | Retrospective Arm | Total |
|---|---|---|---|
| Female | 93 | 518 | 611 |
| Male | 179 | 1079 | 1258 |
| Race and Ethnicity Not Collected(Participants) | Prospective Group | Retrospective Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Prospective Group | Retrospective Arm | Total |
|---|---|---|---|
| United States | 272 | 1597 | 1869 |
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Plan to share: No
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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