Because of their effect on wound healing, and associated influence on recurrence, surgical site occurrences are of great concern in abdominal wall reconstruction. Yet, they are very common. Incisional negative-pressure wound therapy is a promising intervention; a meta-analysis of our research group has shown that current literature suggests that incisional negative pressure wound therapy is effective for clean types of surgery. However, there is a paucity of randomized evidence in contaminated situations. It is therefore, that in the PRESSURE Trial we want to investigate if incisional negative-pressure wound therapy is effective in reducing the amount of postoperative wound complications in contaminated abdominal wall reconstruction. Patients will be included from around 20 hospitals in the Netherlands, England, Denmark, Belgium and Germany.
Patients
388 patients will be randomized. Half of the participants will receive conventional wound care with a gauze-based dressing, the other half will receive incisional negative-pressure wound therapy.
Inclusion criteria
In order to participate in this trial, a subject must meet the following criteria:
• ≥18 years
• Informed consent
• Scheduled for elective, open abdominal wall reconstruction*
• Pre-operative CT available
And one of the following:
• A stoma or enterocutaneous fistula and an abdominal wall defect of >6 cm** on CT
• Violation of the gastrointestinal tract*** and an abdominal wall defect of >6 cm on CT
• Infected mesh (any size)
• Septic dehiscence (any size)
* Operative treatments may include transversus abdominis release, endoscopic external oblique release or open external oblique release, as long as the abdominal wall reconstruction is open. Reconstructions incorporating pedicled or free transfer of tissue (e.g. an antero-lateral thigh or latissimus dorsi flap) are included as well.
** 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
Exclusion criteria
Subjects who meet any of the following criteria will be excluded:
• Patients <18
• Antibiotic treatment during the 7 days before surgery
• Parastomal hernias in which the stoma is not being relocated or taken down and the parastomal hernia is the only defect planned for reconstruction*
*In case of a patient scheduled for reconstruction of both incisional hernia on a different location of the abdomen and a parastomal hernia, the reconstruction of the incisional hernia will be eligible for randomization.
Intervention
Patients will be randomized between:
| A | B |
| Incisional negative pressure wound therapy will the commercially available Prevena ™ Incision Management System (Kinetic Concepts Inc. (Acelity), San Antonio, TX, USA), placed under sterile conditions immediately after skin closure. The device will remain in situ for 7 consecutive days at -125 mm Hg subatmospheric pressure, regardless of discharge. | Conventional wound care through a gauze based dressing as available at the participating hospital. |
Primary outcome
Primary outcome of the PRESSURE Trial will be the amount of patients with a clinically relevant postoperative wound complication during the first 30 days after surgery. A postoperative wound complication is considered clinically relevant when the attending physician considers it of such a severity that it needs further action for purposes of diagnosis (other than clinical examination) or treatment (e.g. ultrasound/CT, antibiotic treatment or drainage).
The following postoperative wound complications are considered part of the primary outcome:
• Superficial surgical site infection*
• Deep surgical site infection*
• Wound cellulitis**
• Wound dehiscence
• Enterocutaneous fistulas
• Seroma
• Hematoma
• Skin ischemia/necrosis
*as defined by the CDC but with the modification that infections need to be proven through culture and that opening of the wound does not count as infection
**wound cellulitis falls out of the CDC criteria but is part of our primary outcome
Secondary outcomes
•The amount of patients with postoperative wound complications on photos taken by the patients (facilitates blinded outcome assessment);
•The amount of patients with postoperative wound complications during the first 90 days after surgery (extended follow-up);
•The amount of patients with recurrence at 1 year after surgery;
•QoL (EQ-5D-5L) •Scar appearance (POSAS 2.0);
•The amount of procedures for postoperative wound complications (e.g. radiologic drainage);
•Length of stay;
•The amount of re-admissions;
•The amount of visits to the ED;
•Non wound related complications;
•Mortality;
•Cost-effectiveness.
Surgeon activities
Patients will be screened for eligibility at the outpatient clinic.
Relevant patient data will need to be registered in the CRF at inclusion.
Furthermore the patient will be seen 1, 3 and 12 months after surgery by the surgeon for assessment which will be registered using the CRF.
Serious Adverse Events (SEA)
An incident is considered a SAE in case of:
· Mortality
· Life threatening
· (Extension of) hospital admission
· Permanent invalidity or occupational disability
All individual SAE’s need to be reported <24 hours to the study coordinator.
