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Negative Pressure Therapy After Infected Mesh Removal.

Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05247086
Acronym
ICROMA
Enrollment
94
Registered
2022-02-18
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Surgical Site

Brief 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.

Detailed description

The surgeon will not know the patient's arm of study before the operation. Once the wound will be closed, we will let know what kind of closure the patient will need. Negative pressure therapy will be the same in all patients, in order to mantain homogeneity. We will set appointments each day while he is hospitalized, and after the discharge: at 7 (+/- 1) and 30 (+/- 5). We will collect demographic data before and during surgery, as well as in the postoperative period, including appointments.

Interventions

After surgical wound closure we will apply negative pressure therapy

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Any gender, adult. Age minimum limits 18. * Infected chronic mesh. * Signing of informed consent.

Exclusion criteria

* Enterocutaneous fistula or enteroatmospheric fistula. * Infected chronic mesh related to parastomal hernia. * Patients who will no complete the follow-up period. * Informed consent denial.

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection30 daysDifferences between surgical site infection between conventional closure vs negative pressure therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026