inflammation wound infection
Conditions
Interventions
NPWTi (after debridement if needed). The wound will be covered with an
open-cell foam and an occlusive drape. During repeated cycles, the wound bed
will be automatically soaked with 0.9% normal sali
cycle length depending on
the bioburden of the wound. The foam and drape are changed every 2-3 days (1
treatment period). At least two treatment periods of 2-3 days need to be
completed before swit
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to participate in this study, a subject must meet all of the following criteria: • Age equal or older than 18 years; • A superficial or deep SSI plus a wound dehiscence (> 5 cm dehiscence) or a wound that needs to be opened for drainage of SSI after any type of surgery; • SSI 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 potential subject who meets any of the following criteria will be excluded from participation in this study: • A deep organ/space SSI without a superficial (involvement of skin and fascia) wound infection • Psychically or mentally inability for informed consent • Fascial dehiscence > 0,5 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: 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 |
|---|---|
| Secondary outcomes: • 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 90 days post-operative; • 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). Additionally, three planned subgroup analysis of wound healing will be performed: (1) NPWT vs. conventional wound care within the standard care group; and (2) wound healing after secondary surgical closure vs. no secondary surgical closure; (3) foreign body-associated infections from implants of index operation vs. no foreign body-associated infections from implants of index operation. | — |
Countries
Netherlands
Outcome results
None listed