An interventional study of Prophylactic Closed-Incision Negative Pressure Wound Therapy and Standard Wound Dressing in ExtraCorporeal Membrane Oxygenation (ECMO), Wound Complications and Surgical Site Infection (SSI), sponsored by St. Antonius Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by St. Antonius Hospital · Not applicable, Interventional, and Prevention
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 144 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following ECMO decannulation, a prophylactic negative pressure wound therapy (NPWT) system is applied under sterile conditions to the closed groin wound in the operating room or ICU. The NPWT system consists of a closed-incision dressing connected to a continuous vacuum device set at -125 mmHg and is maintained for seven days without routine dressing changes. Wound exudate is collected in a canister and monitored during treatment.
Device: Prophylactic Closed-Incision Negative Pressure Wound Therapy
Following ECMO decannulation, a sterile adhesive dressing is applied under sterile conditions to the closed groin wound in the operating room or ICU. Dressings are managed and changed according to local standard care protocols.
Device: Standard Wound Dressing
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.
Also known as: NPWT, Closed-Incision NPWT, ciNPWT, Prevena™ system
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.
Also known as: Standard Wound Care, Sterile Wound Dressing, Conventional Wound Dressing
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.
Time frame: 30 days after ECMO decannulation
Early removal of NPWT
Proportion of patients in whom the NPWT system is removed before completion of the intended 7-day treatment period.
Time frame: Within 7 days after ECMO decannulation
Reasons for early NPWT removal
Documented reasons for premature discontinuation of NPWT prior to 7 days, including medical, technical, or patient-related factors.
Time frame: Within 7 days after ECMO decannulation
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.
Time frame: From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).
Length of ICU stay
Duration of ICU stay in days, calculated from ICU admission to ICU discharge.
Time frame: 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)
Medical interventions related to wound complications
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.
Time frame: Within 30 days after ECMO decannulation
Nursing workload and wound care material use
Daily nursing time spent on wound care and type and quantity of wound care materials used, recorded until hospital discharge.
Time frame: From decannulation until hospital discharge
Number of participants with a healed groin cannulation site
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.
Time frame: Assessed at final hospital discharge, occurring at a variable time point depending on the duration of the individual hospital stay.
EQ-5D-5L index score
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).
Time frame: At hospital discharge and 3 months after final hospital discharge.
Wound-QoL-14 total score in patients discharged with a wound-related complication
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.
Time frame: 3 months after final hospital discharge.
Healthcare utilization and costs
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).
Time frame: Up to 3 months after hospital discharge
No study locations are listed for this record.
Plan to share: Yes — Individual participant data will be shared upon reasonable request, after approval by the study steering committee and in accordance with agreements between participating centers and applicable data protection regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The study protocol will be made available prior to study initiation. The statistical analysis plan and informed consent form will be made available after publication of the primary results.
Access criteria: Access will be granted to qualified researchers who provide a methodologically sound research proposal. De-identified individual participant data, as well as the study protocol, statistical analysis plan, and informed consent form, will be available. Data will be shared upon reasonable request after publication of the primary results, subject to approval by the study steering committee and participating centers. Access will be provided through a secure data sharing process, in accordance with applicable data protection regulations (including GDPR) and after signing a data sharing agreement.
Data sharing details ↗ · example.com
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Nov 2028, 28 months later.
Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 28 months is above that.
Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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