ClOsed incision Negative pressure wound Therapy After ColorecTal Surgery: A randomized controlled trial

Rationale: Surgical site infection (SSI) following abdominal surgery is considered one of the
most significant and frequent complications resulting in mortality, morbidity, and costs.

Objective: Reduction of surgical site infection. Secondary objectives include assessment of
quality of life (QoL), post-operative complications, wound cosmesis and cost-effectiveness of
using negative pressure wound therapy (NPWT) device.

Study design: European Multicenter, open-label, randomized controlled trial.

Study population: Patients aged 18 years and older, undergoing laparoscopic or open
colorectal surgery
Intervention: Patients will be asked for informed consent, and will receive NPWT dressing in
the study group, and standard surgical dressing (SSD) in the control group.

Main study parameters/endpoints: The primary study endpoint is clinically assessed surgical
site infection.

Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: The extent of the burden and risks associated participation could be
considered as small. The invasive procedure performed on behalf of the CONTACT trial is
usage of NPWT dressing performed at the operating theatre under sterile conditions. Previous
studies in other disciplines have shown superiority of NPWT in preventing surgical site
infections. No major risk of the device have been reported since it is used in other disciplines,
however patients might experience discomfort, hematomas and allergic reaction to the
materials composing the device.

Negative pressure wound therapy reduces surgical site infections after colorectal surgery.

Occurence of surgical site infections up to 30 days and quality of life, cosmetic satisfaction of the woundhealing and (in)direct costs of the treatment one year after surgery.

Application of negative pressure wound therapy (PICO 7 device) on closed surgical incisional wounds.