SSI, POWI
Conditions
Interventions
NPWTi (intervention), NPWT and/or conventional wound care (control)
Sponsors
ZONMW
Eligibility
Inclusion criteria
Inclusion criteria: • Age equal or older than 18 years; • A superficial or deep surgical site infection plus a wound dehiscence (> 5 cm dehiscence) or a wound that needs to be opened for drainage of surgical site infection after any type of surgery; • Surgical site infeciton occurring within 30 days after surgery; • A minimum wound size of 10 cm² to allow proper application of the study treatments; • Written informed consent.
Exclusion criteria
Exclusion criteria: • A deep organ/space surgical site infection without a superficial (involvement of skin and fascia) wound infection • Psychically or mentally inability for informed consent • Fascial dehiscence > 0,5 cm • Malignancy in the wound • Untreated osteomyelitis • Enteric fistula • The wound located where there is a risk of unintented fluid delivery to the thoracic or abdominal cavity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete wound healing, defined as re-epithelization of the total wound surface or if the wound is ready for secondary surgical closure (i.e., healthy red granulation tissue without signs of infection or debris). | — |
Secondary
| Measure | Time frame |
|---|---|
| • pain (using a Numeric Rating Scale (NRS) scored for the first two weeks daily; and during dressing changes for the first four weeks); • hospital length of stay (HLOS); • hospital readmissions (wound-related) (within 30 and 90 days after discharge); • frequency and type of surgical procedures related to SSI within 30 and 90 days after start treatment; • health-related quality of life (using the EQ-5D-5L) at baseline; and after 30 & 90 days, 6 and 12 months after inclusion); • patient satisfaction (Numeric Rating Scale (NRS) ranging from 0-10 score); • duration of total wound care, frequency of wound care (e.g., dressing changes) (during admission); • the need for homecare (and duration) for wound care after discharge from hospital; • costs (mean material costs per day; mean costs nursing time per dressing change based Dutch tariff; iMTA Medical Consumption Questionnaire (iMCQ); the iMTA Productivity Cost Questionnaire (iPCQ) at baseline and after 30 & 90 days, 6 and 12 months after inclusion; • professional satisfaction (Numeric Rating Scale (NRS) ranging from 0-10 score). | — |
Contacts
Public ContactHannah Groenen
Amsterdam UMC
Outcome results
None listed