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.

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

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.

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 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.

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.