Peripheral Vascular Diseases, Surgical Wound Infection
Conditions
Keywords
Surgical Site Infection, Vascular Surgery, Negative Pressure Wound Therapy
Brief summary
The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s). Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector. The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.
Detailed description
The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI \> 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device. Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two. The data will be analyzed with an intention to treat analysis.
Interventions
DEVICEPrevena (Negative Pressure Wound Therapy Device)
No other details required.
DEVICEStandard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Sponsors
Kinetic Concepts, Inc.
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI \> 35 * Previous femoral exposure * Undergoing lower-limb revascularization
Exclusion criteria
* Cannot obtain seal * Non-primary wound closure * Pre-existing infection * Endovascular repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | 30 days | Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Date of discharge | Duration (in days) the patient stays in hospital post-operatively |
| Emergency room visits | 30 days | Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment |
| All-cause mortality | 30 days | — |
| Re-operation rate | 30 days | Need for re-operation following graft failure secondary to infection |
| Amputation | 30 days | Need for amputation post-operatively secondary to infection |
Countries
Canada
Contacts
Primary ContactAdam Power, MD
Outcome results
None listed