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Closed Incision NPWT to Prevent Wound Complications Post-ECMO

NCT07709546 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-07-16

No results posted yet for this study

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

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

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.

Sponsors & Collaborators

  • St. Antonius Onderzoeksfonds

    collaborator UNKNOWN

  • St. Antonius innovatiefonds

    collaborator UNKNOWN

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Erik Scholten, MD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2028-11-18
Completion
2029-03-18
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709546 on ClinicalTrials.gov