Closed Incision NPWT to Prevent Wound Complications Post-ECMO (PREVENT-ECMO)
The Prophylactic Effect of Closed Incision Negative Pressure Therapy on Vascular Entry Site Complications Following ECMO Decannulation
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ineke van de Pol, RN, MSc
- Telefonní číslo: +31883206614
- E-mail: i.van.de.pol@antoniusziekenhuis.nl
Studijní záloha kontaktů
- Jméno: Margreet van Rees, RN
- Telefonní číslo: 0883206612
- E-mail: g.van.rees@antoniusziekenhuis.nl
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Prophylactic NPWT
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.
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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.
Ostatní jména:
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Aktivní komparátor: Standard Wound Care
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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cannula-related wound complications (CRWCs)
Časové okno: 30 days after ECMO decannulation
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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.
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30 days after ECMO decannulation
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Early removal of NPWT
Časové okno: Within 7 days after ECMO decannulation
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Proportion of patients in whom the NPWT system is removed before completion of the intended 7-day treatment period.
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Within 7 days after ECMO decannulation
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Reasons for early NPWT removal
Časové okno: Within 7 days after ECMO decannulation
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Documented reasons for premature discontinuation of NPWT prior to 7 days, including medical, technical, or patient-related factors.
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Within 7 days after ECMO decannulation
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Length of hospital stay
Časové okno: From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).
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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.
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From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).
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Length of ICU stay
Časové okno: 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)
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Duration of ICU stay in days, calculated from ICU admission to ICU discharge.
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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)
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Medical interventions related to wound complications
Časové okno: Within 30 days after ECMO decannulation
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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.
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Within 30 days after ECMO decannulation
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Nursing workload and wound care material use
Časové okno: From decannulation until hospital discharge
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Daily nursing time spent on wound care and type and quantity of wound care materials used, recorded until hospital discharge.
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From decannulation until hospital discharge
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Number of participants with a healed groin cannulation site
Časové okno: Assessed at final hospital discharge, occurring at a variable time point depending on the duration of the individual hospital stay.
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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.
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Assessed at final hospital discharge, occurring at a variable time point depending on the duration of the individual hospital stay.
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EQ-5D-5L index score
Časové okno: At hospital discharge and 3 months after final hospital discharge.
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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).
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At hospital discharge and 3 months after final hospital discharge.
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Wound-QoL-14 total score in patients discharged with a wound-related complication
Časové okno: 3 months after final hospital discharge.
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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.
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3 months after final hospital discharge.
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Healthcare utilization and costs
Časové okno: Up to 3 months after hospital discharge
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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).
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Up to 3 months after hospital discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Erik Scholten, MD, St. Antonius Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NL-011305 • PI-01.01
Plán pro data jednotlivých účastníků (IPD)
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Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
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