Negative Pressure Therapy After Infected Mesh Removal. (ICROMA)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Infection, Surgical Site

Treatments: Device: Negative pressure therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05247086

ICROMA PROJECT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Convention closure

No Intervention group

Description:

Conventional closure of the surgical wound after mesh removal surgery.

Negative pressure therapy

Experimental group

Description:

Negative pressure therapy of the surgical wound after mesh removal surgery.

Treatment:

Device: Negative pressure therapy