TY - JOUR
T1 - Negative pressure wound therapy for high-risk wounds in lower extremity revascularization
T2 - Study protocol for a randomized controlled trial
AU - Murphy, Patrick
AU - Lee, Kevin
AU - Dubois, Luc
AU - DeRose, Guy
AU - Forbes, Thomas
AU - Power, Adam
N1 - Funding Information:
Western University ethics board performed a full-board review and approved the trial (REB 104871). The trial is registered at Clinicaltrials.gov (NCT02084017). The study will be funded by the Department of Surgery Resident Research grant from Western University. Kinetic Concepts Inc. (San Antonio, TX, USA) will donate all NPWT devices for this trial and will not have any influence in study design, data collection, statistical analysis or writing of the final manuscript.
Publisher Copyright:
© 2015 Murphy et al.
PY - 2015/11/4
Y1 - 2015/11/4
N2 - 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/design: 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/m2, 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. Discussion: 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. Trial registration:NCT02084017 , March 2014
AB - 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/design: 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/m2, 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. Discussion: 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. Trial registration:NCT02084017 , March 2014
KW - Negative pressure wound therapy
KW - Prevena
KW - Surgical site infection
KW - Vascular surgery
UR - http://www.scopus.com/inward/record.url?scp=84946408903&partnerID=8YFLogxK
U2 - 10.1186/s13063-015-1026-1
DO - 10.1186/s13063-015-1026-1
M3 - Article
C2 - 26537879
AN - SCOPUS:84946408903
VL - 16
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 504
ER -