Abstract
Background/Aims: Inguinal incisions are a common route of access in vascular surgery. Due to anatomical challenges and a diverse bacterial flora in this area, surgical site infections (SSI) represent a common, debilitating and sometimes life-threatening complication. The INVIPS-Trial evaluates the role of Negative Pressure Wound Therapy (NPWT) on closed inguinal incisions in elective vascular surgery to prevent SSI and other wound complications. Methods: This randomized controlled trial (RCT) registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO, Smith & Nephew, UK) and the center’s standard wound dressing (Vitri Pad, ViTri Medical, Sweden) on postoperative wound complications, especially SSI. The study includes two distinct vascular procedures with different SSI risk profiles: endovascular aortic repair (EVAR) and open surgical approaches involving the common femoral artery (OPEN). Results: Four hundred ninety-five groin incisions in both treatment arms are anticipated to be included in the EVAR group and 147 inguinal incisions in both treatment arms in the OPEN group. Since a large percentage of inguinal vascular procedures in both groups but especially in the EVAR group are performed bilaterally, many patients can serve as their own control by randomly receiving NPWT on one and the standard dressing on the contralateral inguinal incision. Conclusions: This ongoing RCT attempts to elucidate the potential benefit of NPWT on closed inguinal incisions after different vascular procedures. Outcome and conclusions of this trial could have implications on postoperative wound care of patients in both vascular surgery and other surgical specialties.
Highlights
Vascular surgery today relies heavily on inguinal access for both endovascular and open surgical procedures
In about 80% of cases, endovascular aortic repair (EVAR) requires a bilateral inguinal approach whereby the transverse incisions are conducted at the end of the procedure and merely serve to repair the femoral artery defect created by the introduction of endovascular material
Vascular surgery with inguinal incisions carries a significant risk for surgical site infections
Summary
Vascular surgery today relies heavily on inguinal access for both endovascular and open surgical procedures. The inguinal region contains a high concentration of virulent bacteria [1], is fairly moist, a high risk area for postoperative lymphorrhea [2] and traverses the hip joint, thereby exposing it to friction and stretching forces These factors increase the risk for surgical site infections (SSI) and infection rates of more than 20% [3] have been reported. It has been demonstrated that INPWT decreases hematoma and seroma formation by removal of wound fluid across the suture line and by locally enhancing the endogenous draining capacity of the lymphatic system [6] This has shown to reduce drainage time in orthopedic patients. The fact that a large proportion of inguinal procedures at this center are conducted bilaterally, allowed for a unique study design whereby patients could receive the INPWT dressing in one and the standard dressing in other groin, thereby serving as their own controls (Figure 1)
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