Closed Incision NPWT to Prevent Wound Complications Post-ECMO

NCT07709546 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: NL-011305 • PI-01.01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Wound Complications; ExtraCorporeal Membrane Oxygenation (ECMO); Surgical Site Infection (SSI)

Keywords

ECMO; Extracorporeal Membrane Oxygenation; Negative Pressure Wound Therapy; NPWT; Prevena; Closed Incision Negative Pressure Therapy; ciNPT; Wound Complications; Surgical Site Infection; CRWC; Groin wound; Vascular access site

Outcome Measures

Primary Outcomes (1)

• Cannula-related wound complications (CRWCs)

  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.

  30 days after ECMO decannulation

Secondary Outcomes (10)

• 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

Study Arms (2)

Prophylactic NPWT

EXPERIMENTAL

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.

Device: Prophylactic Closed-Incision Negative Pressure Wound Therapy

Standard Wound Care

ACTIVE COMPARATOR

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.

Device: Standard Wound Dressing

Interventions

Prophylactic Closed-Incision Negative Pressure Wound Therapy DEVICE

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.

Also known as: NPWT, Closed-Incision NPWT, ciNPWT, Prevena™ system

Prophylactic NPWT

Standard Wound Dressing DEVICE

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.

Also known as: Standard Wound Care, Sterile Wound Dressing, Conventional Wound Dressing

Standard Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• St. Antonius Onderzoeksfonds: collaborator
• St. Antonius innovatiefonds: collaborator

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik Scholten, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ineke van de Pol, RN, MSc

CONTACT

+31883206614; i.van.de.pol@antoniusziekenhuis.nl

Margreet van Rees, RN

CONTACT

0883206612; g.van.rees@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator, Anesthesiologist-Intensivist

Model Details: This study is a prospective, multi-center, randomized controlled open-label trial with a parallel assignment design. Participants are randomized in a 1:1 ratio to receive either prophylactic negative pressure wound therapy (NPWT) or standard wound care, using block randomization stratified by center, ECMO modality (veno-venous \[VV\] ECMO or veno-arterial \[VA\] ECMO, including relevant triple cannulation modes or ECPR), and the number of cannulated groins (one versus two). Following ECMO decannulation, the allocated treatment is applied immediately and maintained for seven days. In patients with bilateral groin cannulation, treatment is applied bilaterally. The study is open-label for patients and clinical staff, while outcome assessment is performed by blinded specialized wound nurses based on standardized photographs and objective parameters at days 8, 15, and 30.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 16, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): November 18, 2028
• Study Completion (Estimated): March 18, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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 Criteria: 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.