Surgical Wound Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
OTHERConventional sterile dry wound dressing
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
Sponsors
KCI USA, Inc
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Transplant patients 2. BMI \>30 3. Type I (insulin-dependent) diabetics 4. Severe chronic obstructive pulmonary disease (COPD) 5. Steroid-dependent patients 6. Previous Tracheostomy
Exclusion criteria
1. BMI\<30 2. Thoracotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Infection After Open Heart Surgery | 30 days post-surgery | The total number of participants with surgical site infections after cardiac surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation for Wound Infection | 30 days post surgery | The total number of reoperations required due to infection. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | postoperative to discharge | Length of stay was defined as the number of nights spent in the hospital after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Group Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. | 272 |
| Retrospective Arm Conventional sterile dry wound dressing applied immediately postoperatively. | 1,597 |
| Total | 1,869 |
Baseline characteristics
| Characteristic | Retrospective Arm | Total | Prospective Group |
|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 12.4 | 64.5 years STANDARD_DEVIATION 12.4 | 63.3 years STANDARD_DEVIATION 12.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1597 participants | 1869 participants | 272 participants |
| Sex: Female, Male Female | 518 Participants | 611 Participants | 93 Participants |
| Sex: Female, Male Male | 1079 Participants | 1258 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 272 | 0 / 1,597 |
| other Total, other adverse events | 0 / 272 | 0 / 1,597 |
| serious Total, serious adverse events | 0 / 272 | 0 / 1,597 |
Outcome results
Primary
Wound Infection After Open Heart Surgery
The total number of participants with surgical site infections after cardiac surgery.
Time frame: 30 days post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Group | Wound Infection After Open Heart Surgery | 4 Participants |
| Retrospective Arm | Wound Infection After Open Heart Surgery | 17 Participants |
p-value: 0.55Fisher Exact
Secondary
Reoperation for Wound Infection
The total number of reoperations required due to infection.
Time frame: 30 days post surgery
Population: Data on reoperation was not collected.
Other Pre-specified
Length of Stay
Length of stay was defined as the number of nights spent in the hospital after surgery.
Time frame: postoperative to discharge
Population: Data for this outcome measure was not collected.