Patients undergoing extracorporeal membrane oxygenation (ECMO) are at increased risk of wound complications at the vascular access site after decannulation. These complications may delay recovery and increase healthcare burden. Closed incision negative pressure wound therapy (NPWT) may improve wound healing by reducing fluid accumulation and supporting the incision. This study evaluates whether prophylactic NPWT reduces wound complications compared to standard wound care following ECMO decannulation.
Patient is aged 18 years or older
Is currently receiving ECMO therapy and is eligible for weaning from the device
The patient must have at least one cannula inserted at the groin site
(Proxy) informed consent
Duration ECMO run < 24 hours
Expected death within 24 hours after decannulation
Extracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+)
Wound closure is not possible after decannulation.
Parallel
Prophylactic Closed-Incision Negative Pressure Wound Therapy
DeviceProphylactic closed-incision negative pressure wound therapy (NPWT) is applied immediately following ECMO decannulation to closed groin wounds. The system consists of a sealed dressing connected to a continuous vacuum device set at -125 mmHg and is maintained for seven days without routine dressing changes. This intervention is specifically used to prevent wound complications in high-risk ECMO patients and is applied to one or both groins depending on cannulation.
Standard Wound Dressing
DeviceStandard wound dressing is applied to closed groin wounds immediately following ECMO decannulation under sterile conditions. The dressing consists of a conventional sterile adhesive covering without the application of negative pressure or active fluid management. Dressings are changed as clinically indicated according to local standard care protocols.
Cannula-related wound complications (CRWCs)
Cannula-related wound complications (CRWCs) are defined as the occurrence of at least one of the following conditions at the groin cannulation site: hematoma, seroma or fluid collection (with or without exudate leakage), excessive wound exudate, wound dehiscence, fibrinous slough or necrosis, or surgical site infection (SSI) classified according to CDC criteria. In patients with bilateral groin cannulation, the presence of a CRWC at either site is considered as a positive outcome.
Early removal of NPWT
Proportion of patients in whom the NPWT system is removed before completion of the intended 7-day treatment period.
Reasons for early NPWT removal
Documented reasons for premature discontinuation of NPWT prior to 7 days, including medical, technical, or patient-related factors.
Length of hospital stay
Hospital length of stay in days, calculated from initial hospital admission to final hospital discharge, including interhospital transfers as part of a single continuous hospital stay.
Length of ICU stay
Duration of ICU stay in days, calculated from ICU admission to ICU discharge.
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St. Antonius Hospital
Lead sponsor
St. Antonius Onderzoeksfonds
Collaborator
St. Antonius innovatiefonds
Collaborator
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