title: Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization.
  
  
  METHODS
  In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed.
  
  
  CONCLUSIONS
  The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs.
  
  
  BACKGROUND
  NCT02084017 , March 2014.
authors.affiliation: Division of General Surgery, Department of Surgery, Western University, 1151 Richmond Street, London, ON, N6A 5A5, Canada. patrick.murphy@londonhospitals.ca.
authors.forename: Patrick
authors.initials: P
authors.lastname: Murphy
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. leekev10@gmail.com.
authors.forename: Kevin
authors.initials: K
authors.lastname: Lee
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. luc.dubois@lhsc.on.ca.
authors.forename: Luc
authors.initials: L
authors.lastname: Dubois
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. guy.derose@lhsc.on.ca.
authors.forename: Guy
authors.initials: G
authors.lastname: DeRose
authors.affiliation: Division of Vascular Surgery, Department of Surgery, University of Toronto, 149 College Street, Toronto, ON, M5T 1P5, Canada. tom.forbes@lhsc.on.ca.
authors.forename: Thomas
authors.initials: T
authors.lastname: Forbes
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. adam.power@lhsc.on.ca.
authors.forename: Adam
authors.initials: A
authors.lastname: Power
mesh_terms: D000671:Amputation, Surgical; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004636:Emergency Service, Hospital; D005263:Femoral Artery / Q000601:surgery*; D017048:Health Care Costs; D006801:Humans; D007902:Length of Stay; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D054843:Negative-Pressure Wound Therapy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D009864:Ontario; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D012086:Reoperation; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000191:economics / Q000382:microbiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000009:adverse effects* / Q000191:economics / Q000401:mortality; D014945:Wound Healing