The Prophylactic Effect of Closed Incision Negative Pressure Therapy on Vascular Entry Site Complications Following ECMO Decannulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Cannula-related wound complications (CRWCs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cannula-related wound complications (CRWCs)
时间窗: 30 days after ECMO decannulation
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.
次要结局
- Early removal of NPWT(Within 7 days after ECMO decannulation)
- Reasons for early NPWT removal(Within 7 days after ECMO decannulation)
- Length of hospital stay(From initial hospital admission until final hospital discharge (variable duration depending on individual hospital stay).)
- Length of ICU stay(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(Within 30 days after ECMO decannulation)
- Nursing workload and wound care material use(From decannulation until hospital discharge)
- Number of participants with a healed groin cannulation site(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(At hospital discharge and 3 months after final hospital discharge.)
- Wound-QoL-14 total score in patients discharged with a wound-related complication(3 months after final hospital discharge.)
- Healthcare utilization and costs(Up to 3 months after hospital discharge)
研究者
dr. Peter Noordzij, MD PhD
Co-Principal Investigator, Anesthesiologist-Intensivist
St. Antonius Hospital