ExtraCorporeal Membrane Oxygenation (ECMO), Surgical Site Infection (SSI), Wound Complications
Conditions
Keywords
ECMO, Extracorporeal Membrane Oxygenation, Negative Pressure Wound Therapy, NPWT, Prevena, Closed Incision Negative Pressure Therapy, ciNPT, Wound Complications, Surgical Site Infection, CRWC, Groin wound, Vascular access site
Brief summary
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.
Detailed description
Wound healing at the vascular access site is frequently impaired in patients following extracorporeal membrane oxygenation (ECMO). Cannulation-related wound complications (CRWCs), most commonly occurring in the groin, contribute to patient discomfort, delayed recovery, increased nursing workload, and higher healthcare costs. The aim of this study is to evaluate whether prophylactic negative pressure wound therapy (NPWT) reduces the incidence of CRWCs following ECMO decannulation compared to standard wound care. The primary objective of this randomized controlled trial is to determine whether NPWT is superior to standard wound care with respect to the occurrence of CRWCs within 30 days after decannulation. This study is designed as a prospective, multi-center, randomized, open-label trial. Adult patients (≥18 years) who have undergone ECMO treatment will be eligible for inclusion. Following ECMO decannulation, patients in the intervention group will receive prophylactic NPWT applied to the closed groin wound for seven days. Patients in the control group will receive standard wound care using sterile adhesive dressings according to local protocols. The primary outcome is the incidence of CRWCs within 30 days after ECMO decannulation. Secondary outcomes include the proportion of patients requiring premature discontinuation of NPWT (\<7 days) and reasons for discontinuation, length of stay in the intensive care unit and hospital, wound healing status at discharge, and wound-related complications. In addition, patient-reported outcomes will be assessed, including wound-related quality of life (Wound-QoL-14) and general health-related quality of life (EQ-5D-5L) at three months after discharge. Healthcare utilization, including medical consumption and productivity losses, will also be evaluated using validated questionnaires, and total healthcare costs will be assessed up to three months post-discharge. Patients receiving ECMO are at high risk of complications, including CRWCs, and optimal wound management is essential. Prophylactic NPWT is already widely used in various surgical settings to support wound healing in high-risk patients. Studies in vascular and other surgical populations have shown that NPWT on groin incisions can significantly reduce surgical site infections and wound-related complications compared to standard dressings. The mechanism of NPWT, including removal of exudate and infectious material, reduction of edema and seroma formation, and stabilization of wound edges, directly targets key factors involved in impaired wound healing after ECMO decannulation. Participation in this study is associated with minimal additional burden. The intervention is applied as part of routine postoperative care and does not extend beyond the hospital stay. Wound assessments follow standard clinical protocols. Additional data on quality of life and healthcare use will be collected through a digital questionnaire three months after discharge. Participation is not expected to introduce significant additional risks, while it may offer potential benefits through improved wound healing and reduced complications.
Interventions
DEVICEProphylactic Closed-Incision Negative Pressure Wound Therapy
Prophylactic 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.
DEVICEStandard Wound Dressing
Standard 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.
Sponsors
St. Antonius Hospital
St. Antonius Onderzoeksfonds
St. Antonius innovatiefonds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Although the study is open-label for patients and treating clinicians, outcome assessors are blinded to treatment allocation. Wound assessments are performed by specialized wound nurses using standardized photographs and objective parameters. Prior to assessment, NPWT dressings are removed and replaced with standard dressings to maintain blinding.
Intervention model description
This study is a prospective, multi-center, randomized controlled open-label trial with a parallel assignment design. Participants are randomized in a 1:1 ratio to receive either prophylactic negative pressure wound therapy (NPWT) or standard wound care, using block randomization stratified by center, ECMO modality (veno-venous \[VV\] ECMO or veno-arterial \[VA\] ECMO, including relevant triple cannulation modes or ECPR), and the number of cannulated groins (one versus two). Following ECMO decannulation, the allocated treatment is applied immediately and maintained for seven days. In patients with bilateral groin cannulation, treatment is applied bilaterally. The study is open-label for patients and clinical staff, while outcome assessment is performed by blinded specialized wound nurses based on standardized photographs and objective parameters at days 8, 15, and 30.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * Presence of drain in the wound site * Participants who are not proficient in Dutch or English, or whose legal representative is not proficient, if applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannula-related wound complications (CRWCs) | 30 days after ECMO decannulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early removal of NPWT | Within 7 days after ECMO decannulation | Proportion of patients in whom the NPWT system is removed before completion of the intended 7-day treatment period. |
| Reasons for early NPWT removal | Within 7 days after ECMO decannulation | Documented reasons for premature discontinuation of NPWT prior to 7 days, including medical, technical, or patient-related factors. |
| Length of hospital stay | From initial hospital admission until final hospital discharge (variable duration depending on individual 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 | From ICU admission until ICU discharge, with duration calculated as the number of days between ICU admission and ICU discharge. (variable duration depending on individual ICU stay) | Duration of ICU stay in days, calculated from ICU admission to ICU discharge. |
| Medical interventions related to wound complications | Within 30 days after ECMO decannulation | Occurrence of medical interventions related to cannula-related wound complications, including duration of intensive wound care, use of advanced wound dressings, negative pressure wound therapy (VAC), antibiotic treatment, debridement, surgical interventions (including muscle flap repair), and other wound-related treatments. |
| Nursing workload and wound care material use | From decannulation until hospital discharge | Daily nursing time spent on wound care and type and quantity of wound care materials used, recorded until hospital discharge. |
| Number of participants with a healed groin cannulation site | Assessed at final hospital discharge, occurring at a variable time point depending on the duration of the individual hospital stay. | A groin cannulation site is considered healed when complete skin closure has been achieved, no wound dressings or dressing changes are required, and no further wound-related interventions are indicated, based on clinical assessment. |
| EQ-5D-5L index score | At hospital discharge and 3 months after final hospital discharge. | Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Responses are converted into an EQ-5D-5L index value using the applicable value set for economic evaluation and quality-adjusted life year (QALY) calculations. Higher index scores indicate better health-related quality of life. The index score ranges from values below 0 (health states considered worse than death) to 1.0 (full health). |
| Wound-QoL-14 total score in patients discharged with a wound-related complication | 3 months after final hospital discharge. | Wound-related quality of life measured using the Wound Quality of Life-14 (Wound-QoL-14) questionnaire in patients discharged from the hospital with a clinically relevant wound complication (CRWC). The Wound-QoL-14 assesses the impact of wound-related symptoms, limitations in daily activities, and psychological burden. Scores are calculated according to the questionnaire scoring manual, with higher scores indicating worse wound-related quality of life. |
| Healthcare utilization and costs | Up to 3 months after hospital discharge | Healthcare utilization and associated costs assessed using the iMTA Medical Consumption Questionnaire (iMCQ), including home care involvement, and productivity losses measured using the iMTA Productivity Cost Questionnaire (iPCQ). |
Contacts
CONTACTIneke van de Pol, RN, MSc
CONTACTMargreet van Rees, RN
PRINCIPAL_INVESTIGATORErik Scholten, MD
St. Antonius Hospital
Outcome results
None listed