RCT incisional NPWT versus sterile surgical dressing for surgical wounds after arterial vascular surgery

SUMMARY

Rationale:

Complications after vascular arterial surgery are common and can be very serious. They prolongs hospital stay and increases costs. In the Haaglanden Medical Centre both Incisional Negative Pressure Wound Therapy (INPWT) and Sterile Surgical Dressing (SSD) are used as post-operative dressings. There is growing evidence that INPWT might prevent surgical wound complications, which will promote patients wellbeing and decrease costs.



Objective:

Primary Objective: to investigate if INPWT will prevent wound complications such as wound dehiscence, wound infection, seroma leakage and wound necrosis after arterial vascular surgery. Secondary Objective(s): to investigate if INPWT will prevent additional surgery, prolonged hospital stay, re-admissions and extra visits to the outpatient clinic and thereby and reduce costs.



Study design:

A prospective randomized controlled clinical trial of two different postoperative wound treatments.



Study population:

All patients that underwent vascular arterial surgery with one or more groin incisions. Except patients for Endovascular Abdominal Repair (EVAR).



Intervention (if applicable):

Incisional Negative Pressure Wound Therapy (Prevena ®) or sterile surgical dressing (Curapor®).



Main study parameters/endpoints:

Wound complications such as SSI, wound dehiscence, seroma leak and wound necrosis and complete wound healing.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Both therapies are standard and safe therapies and will not harm patients. Additional there will be no extra burden for the patients.

Null hypothesis:

There is no differences in amount and seriousness of wound complications between the INPWT and SSD wound application technique after vascular surgery at the groin.

1,2,4 after surgery and date complete wound healing

Incisional Negative Pressure Wound Therapy for surgical closed incision (Prevena)