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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
No other details required.
Victoria Hospital
London, Ontario, Canada
RECRUITINGSurgical Site Infection
Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.
Time frame: 30 days
Length of stay
Duration (in days) the patient stays in hospital post-operatively
Time frame: Date of discharge
Emergency room visits
Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Re-operation rate
Need for re-operation following graft failure secondary to infection
Time frame: 30 days
Amputation
Need for amputation post-operatively secondary to infection
Time frame: 30 days
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