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| Name | Class |
|---|---|
| KCI USA, Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective group | Experimental | Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. |
|
| Retrospective arm | Active Comparator | Conventional sterile dry wound dressing applied immediately postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Incision Management System | Device | negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Infection After Open Heart Surgery | The total number of participants with surgical site infections after cardiac surgery. | 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation for Wound Infection | The total number of reoperations required due to infection. | 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay was defined as the number of nights spent in the hospital after surgery. | postoperative to discharge |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hartzell V Schaff, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Group | Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. |
| FG001 | Retrospective Arm | Conventional sterile dry wound dressing applied immediately postoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Group | Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. |
| BG001 | Retrospective Arm | Conventional sterile dry wound dressing applied immediately postoperatively. |
| 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 | Wound Infection After Open Heart Surgery | The total number of participants with surgical site infections after cardiac surgery. | Posted | Count of Participants | Participants | 30 days post-surgery |
|
Adverse events were collected for 30 days postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Group | Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hartzell V. Schaff | Mayo Clinic | 507-255-7066 | schaff.hartzell@mayo.edu |
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| 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 | Sep 23, 2016 | Feb 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
| Conventional sterile dry wound dressing | Other | regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy |
|
|
| 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 | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Reoperation for Wound Infection | The total number of reoperations required due to infection. | Data on reoperation was not collected. | Posted | 30 days post surgery |
|
|
| Other Pre-specified | Length of Stay | Length of stay was defined as the number of nights spent in the hospital after surgery. | Data for this outcome measure was not collected. | Posted | postoperative to discharge |
|
|
| 0 |
| 272 |
| 0 |
| 272 |
| 0 |
| 272 |
| EG001 | Retrospective Arm | Conventional sterile dry wound dressing applied immediately postoperatively. | 0 | 1,597 | 0 | 1,597 | 0 | 1,597 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |