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Negative Pressure Therapy After Infected Mesh Removal.

NCT05247086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2022-02-18

No results posted yet for this study

Summary

Chronic mesh infection mesh is a complication with leads to a long hospital stays, reoperation and admissions through emergency department. Surgical site infection (SSI) after removal are 58-72.7% depending on the published series. New therapeutic lines are needed in order to improve outcomes after surgery such as negative pressure therapy.

The main objective is to determine the SSI differences depending on the use of negative pressure therapy after infected mesh removal.

Material and methods: multicentric, prospective, randomized and an open comparative study. Patients will be selected sequentially n=94. Each selected patient will be randomized in two groups: conventional closure of the surgical wound vs. negative pressure therapy with a 30-day follow-up.

Conditions

  • Infection, Surgical Site

Interventions

DEVICE

Negative pressure therapy

After surgical wound closure we will apply negative pressure therapy

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-09-30
Completion
2023-12-31

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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 NCT05247086 on ClinicalTrials.gov