Groin Infections, Surgical Site Infection
Conditions
Keywords
Negative Pressure Wound Therapy
Brief summary
The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.
Detailed description
Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision. * 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge. * 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
Interventions
DEVICENegative Pressure Pressure Wound Therapy
Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.
PROCEDUREStandard Wound Care
Standard sterile gauze coverage of the primarily closed groin wound.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
As this intervention necessitated the use of an external negative wound therapy device, masking is not possible
Intervention model description
Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
One or more of the following * Body Mass Index \>30 kg/m2 * Critical limb ischemia defined by Ankle Brachial Index\<0.35, rest pain, tissue loss and/or non-healing ulcers * Procedure time \>240 min * End Stage Renal Disease on dialysis * Glycated hemoglobin ≥ 8.5% * Transfusion ≥ 3 units packed Red Blood Cells * Previous femoral artery cut-down
Exclusion criteria
Any of the following * Preexisting groin infection * Complete vacuum seal cannot be achieved with negative pressure device * Allergy to Adhesive Material * Groin Surgery within last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superficial surgical site infection | 30 days postoperatively | Surgical site infection as defined by the Center for disease control and prevention criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Occurrence of mortality within 30 days of surgery |
| Limb Loss | 30 days and 1 year | Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery |
| Emergency department visit for wound complication | within 30 days of surgery | Number of participants returning to the emergency department for wound complications within 30 days of surgery |
| Local reaction to negative wound dressing | 5 days postoperatively | Occurrence of a local reaction at the site of the negative pressure apparatus during application |
Countries
United States
Outcome results
None listed