Aneurysm, Peripheral Arterial Disease, Surgical Wound Dehiscence, Wound Infection
Conditions
Brief summary
The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
Detailed description
The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.
Interventions
DEVICEPrevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
DEVICEDry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study
Exclusion criteria
* Emergency procedure * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Groin Wound Complication | 30 days | Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 30 days | Readmission to inpatient hospital for management of wound complications |
| Return to Operating Room | 30 days | Return to operating room for surgical management of wound complications |
| Hospital Readmission | 30 days | Readmission for wound complication |
| Index Hospital Cost | 30 days | Index Hospital Cost |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaul DiMuzio, MD
Thomas Jefferson University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 1 / 60 | 0 / 21 |
| other Total, other adverse events | 0 / 59 | 0 / 60 | 0 / 21 |
| serious Total, serious adverse events | 2 / 59 | 1 / 60 | 0 / 21 |
Outcome results
None listed