Closed Incision NPWT to Prevent Wound Complications Post-ECMO

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.

• Early removal of NPWT [Срок оценки: Within 7 days after ECMO decannulation]
• Reasons for early NPWT removal [Срок оценки: Within 7 days after ECMO decannulation]
• Length of hospital stay [Срок оценки: From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).]
• Length of ICU stay [Срок оценки: 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 [Срок оценки: Within 30 days after ECMO decannulation]
• Nursing workload and wound care material use [Срок оценки: From decannulation until hospital discharge]
• Number of participants with a healed groin cannulation site [Срок оценки: 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 [Срок оценки: At hospital discharge and 3 months after final hospital discharge.]
• Wound-QoL-14 total score in patients discharged with a wound-related complication [Срок оценки: 3 months after final hospital discharge.]
• Healthcare utilization and costs [Срок оценки: Up to 3 months after hospital discharge]