TITLE:
Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Infection after Vascular Surgery with Inguinal Incisions: Rationale and Design of a Randomized Controlled Trial (INVIPS-Trial)
AUTHORS:
Julien Hasselmann, Tobias Kühme, Jonas Björk, Stefan Acosta
KEYWORDS:
Incisional Negative Pressure Wound Therapy, Vascular Surgery, Inguinal Incisions, Surgical Site Infection, Randomized Controlled Trial, Research Design
JOURNAL NAME:
Surgical Science,
Vol.6 No.12,
December
30,
2015
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.