Closed Incision NPWT to Prevent Wound Complications Post-ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prophylactic Closed-Incision Negative Pressure Wound Therapy, Standard Wound Dressing.
- Who it may be relevant to
- Registry conditions: ExtraCorporeal Membrane Oxygenation (ECMO), Wound Complications, Surgical Site Infection (SSI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Prophylactic Effect of Closed Incision Negative Pressure Therapy on Vascular Entry Site Complications Following ECMO Decannulation
Overview
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
- Device Prophylactic 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. - Device Standard 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.
Primary outcome measures
- Cannula-related wound complications (CRWCs) [Time frame: 30 days after ECMO decannulation]
Secondary outcome measures (10)
- Early removal of NPWT [Time frame: Within 7 days after ECMO decannulation]
- Reasons for early NPWT removal [Time frame: Within 7 days after ECMO decannulation]
- Length of hospital stay [Time frame: From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).]
- Length of ICU stay [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 [Time frame: Within 30 days after ECMO decannulation]
- Nursing workload and wound care material use [Time frame: From decannulation until hospital discharge]
- Number of participants with a healed groin cannulation site [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 [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 [Time frame: 3 months after final hospital discharge.]
- Healthcare utilization and costs [Time frame: Up to 3 months after hospital discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07709546 · NL-011305 • PI-01.01