The PRESSURE Trial

SUMMARY

Rationale & Objective:

With an incidence of up to 46% in contaminated abdominal wall reconstruction, surgical site occurrences (SSO) are an overly frequent problem in leading to significant morbidity and mortality. Evidence suggests incisional negative pressure wound therapy (iNPWT) reduces SSO in clean surgery. However, there is a paucity of RCTs describing usage of iNPWT in contaminated surgery. Therefore, we propose conducting this RCT with the hypothesis that iNPWT decreases the number of patients that develop SSO in contaminated abdominal wall reconstruction.

Study design:

An investigator-initiated, multinational, multicenter, pragmatic, randomized controlled trial with parallel group superiority design in our collaborative international network, randomizing 388 patients with a 1:1 ratio.

Study population:

In order to participate in this trial, a subject must meet the following criteria:

• ≥18 years

• Scheduled for elective, open abdominal wall reconstruction

• Pre-operative CT available performed within 12 month after last abdominal intervention

And one of the following:

• A stoma or enterocutaneous fistula and a defect of >6 cm* in size on CT

• Violation of the gastrointestinal tract** and defect of >6 cm in size on CT

• Infected mesh (any size)

• Septic dehiscence (any size)

*In case of parastomal hernia and the patient is candidate for ostomy takedown or relocation, the resulting defect in the abdominal wall should be taken for this measure



Intervention:

In this trial, commercially available incisional negative pressure wound therapy will be compared with conventional wound care (defined as a simple, sterile, gauze based dressing as routinely used at the participating hospital site).



Main study endpoint:

The primary outcome is the number of patients with at least one surgical site occurrence (surgical site infection, wound dehiscence, enterocutaneous fistula, seroma, hematoma, skin or wound ischemia/necrosis) 30 days after surgery, with extended follow-up at 90 days and 1 year after surgery. The amount of distinct surgical site occurrence components (e.g. dehiscence) will be registered as secondary outcome as well. Other important secondary outcomes are QoL and hernia recurrence.

Incisional negative pressure wound therapy reduces the amount of patients with clinically relevant surgical site occurrences within 30 days after contaminated abdominal wall reconstruction.

30 days, 90 days, and one year after surgery

Incisional negative pressure wound therapy