surigical site infection wound infection
Conditions
Interventions
NPWT especially designed for closed wounds under the brand name Pico* is the
investigational product in this study. Its features include a single-patient
use continuous vacuum system set to 80 mm Hg
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients >= 18 years old, undergoing laparoscopic or open colorectal surgery and have the ability to understand and willing to sign the written informed consent.
Exclusion criteria
Exclusion criteria: - pregnancy - patients with known allergies to the adhesive materials that would be used - perineal wounds - perioperative HIPEC treatment - purse-string suture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of incisional SSI within 30 days of surgery. In accordance with Centre for Disease Control and Prevention (CDC) and National Healthcare Safety Network (NHSN) SSI is defined as (24, 25) as: Superficial incisional SSI Infection occurs within 30 days after surgery and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician. Deep incisional SSI Infection occurs within 30 days after surgery if no implant is left in place or within 1 year if implant is in place and the infection appears to be related to the operation and Infection involves deep soft tissues (eg fascial and muscle layers) of the incision and at least 1 of the following: 1. Purulent drainage from the deep incision but not from the organ/space component of the surgical site. 2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (>38.0°C), localized pain, or tenderness, unless site is culture-negative. 3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination. 4. Diagnosis of a deep incisional SSI by a surgeon or attending physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| • QoL QoL will be assessed using the SF36 and EQ-5D-5L questionnaire, which will be conducted at admission, day 30 and day 365 postoperatively. • Postoperative complications All postoperative complications will be recorded in the Case Reporting Form (CRF) including date of occurrence, diagnosis procedure and treatment. • Cost Cost will be considered the analysis of the device*s cost versus the effectiveness of its usage by decreasing the incidence of the SSI. Reduction in health related problems as a consequence will economically be analysed at day 30 and day 365 postoperatively using the SF-HLQ questionnaire. • Cosmesis Cosmesis will be assessed 365 days after the surgery by complying the POSAS questionnaire from the patient and the observer(26). | — |
Countries
Netherlands
Outcome results
None listed