cannulation-related wound complications wound complications
Conditions
Interventions
is a non-invasive, evidence-based therapy and is applied to the closed groin wound for seven days to reduce the incidence of CRWCs. NPWT, already used in other surgical specialties for high-risk wound
The control group receives standard wound care with a sterile adhesive dressing. 
Prophylactic Negative Pressure Wound Therapy  
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is aged 18 years or olderIs currently receiving ECMO therapy and is eligible for weaning from the deviceThe patient must have at least one cannula inserted at the groin site (Proxy) informed consent
Exclusion criteria
Exclusion criteria: Duration ECMO run < 24 hoursExpected death within 24 hours after decannulationExtracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+) Wound closure is not possible after decannulation.Presence of drain in the wound siteParticipants who are not proficient in Dutch or English, or whose legal representative is not proficient, if applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this randomized trial is to evaluate whether prophylactic NPWT is superior to standard wound care in reducing the 30-day incidence of CRWCs in patients following ECMO decannulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this trial is to study: Asses the Incidence of CRWCs at day 8, 15 and 30 post-decannulationEvaluate intervention feasibility, defined as the proportion of patients completing 7 days of prophylactic NPWTAsses nursing workload and material consumption related to cannulation wound care Document wound healing status at hospital discharge Cost-effectiveness analysis (CEA):CEA will compare NPWT to standard care from a societal perspective. Quality of life will be measured using EQ-5D-5L at discharge and 3 months, converted to QALYs. Healthcare costs include direct medical costs (hospital stay, readmissions, outpatient care, LOS) and productivity losses (iPCQ). | — |
Countries
Netherlands
Contacts
Public ContactE Scholten
St. Antonius Ziekenhuis
Outcome results
None listed