Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
- Conditions
- Peripheral Vascular DiseasesSurgical Wound Infection
- Interventions
- Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressingDevice: Prevena (Negative Pressure Wound Therapy Device)
- Registration Number
- NCT02084017
- Lead Sponsor
- Western University, Canada
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- BMI > 35
- Previous femoral exposure
- Undergoing lower-limb revascularization
- Cannot obtain seal
- Non-primary wound closure
- Pre-existing infection
- Endovascular repair
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Current Standard Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing applied under sterile conditions in the operating room following skin closure. Dressing changed post-operative day two and daily thereafter with daily inspection for infection by a physician. Negative Pressure Wound Therapy Prevena (Negative Pressure Wound Therapy Device) A negative pressure therapy (Kinetic Concepts, Inc, San Antionio, Tex) device will be applied under sterile conditions post-operatively and placed on suction (125-150 cm H2O). The device will be removed on post-operative day 4-7 depending on day of discharge.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method All-cause mortality 30 days Amputation 30 days Need for amputation post-operatively secondary to infection
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
Length of stay Date of discharge Duration (in days) the patient stays in hospital post-operatively
Re-operation rate 30 days Need for re-operation following graft failure secondary to infection
Trial Locations
- Locations (1)
Victoria Hospital
🇨🇦London, Ontario, Canada