Wound Infection
Conditions
Brief summary
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.
Detailed description
Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.
Interventions
A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
DEVICEDermabond
A surgical skin adhesive used to prevent surgical wound infections
Sponsors
KCI USA, Inc
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. In need of elective vascular procedure requiring ≥8 cm groin incision. 2. Able to provide consent 3. Able to care for wound or have support person to complete wound care 4. Willing to comply with follow-up
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond | 30 days | The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Care | 30 days | Comparison of cost of treatment between the two arms |
| Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection | 30 days | Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from UBMD Vascular Surgery Office and were consented at the time of surgery at Buffalo General Medical Center between 2016 and 2019.
Participants by arm
| Arm | Count |
|---|---|
| Prevena Prevena Incision Management System for vascular surgical groin wounds
Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections | 46 |
| Dermabond Dermabond for vascular surgical groin wounds
Dermabond: A surgical skin adhesive used to prevent surgical wound infections | 55 |
| Total | 101 |
Baseline characteristics
| Characteristic | Dermabond | Total | Prevena |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 65 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 36 Participants | 16 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 12 | 68 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 87 Participants | 36 Participants |
| Region of Enrollment United States | 55 participants | 101 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 36 Participants | 21 Participants |
| Sex: Female, Male Male | 40 Participants | 65 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 55 |
| other Total, other adverse events | 0 / 46 | 0 / 55 |
| serious Total, serious adverse events | 3 / 46 | 2 / 55 |
Outcome results
Primary
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena | Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond | 41 Participants |
| Dermabond | Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond | 54 Participants |
Secondary
Cost of Care
Comparison of cost of treatment between the two arms
Time frame: 30 days
Population: not analyzed as the primary outcome did not demonstrate improved outcomes, and the device being tested, wound vacuum, was more expensive. Had outcomes clinically been improved, financial assessment would have determined whether cost of infection outweighed cost of device.
Secondary
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena | Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection | 7 Participants |
| Dermabond | Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection | 7 Participants |