Negative Pressure Therapy After Infected Mesh Removal.

NCT ID: NCT05247086

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Infection, Surgical Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Convention closure

Conventional closure of the surgical wound after mesh removal surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Negative pressure therapy

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

Group Type: EXPERIMENTAL

Negative pressure therapy

Intervention Type: DEVICE

After surgical wound closure we will apply negative pressure therapy

Interventions

Negative pressure therapy

After surgical wound closure we will apply negative pressure therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ICROMA PROJECT

Identifier Type: -

Identifier Source: org_study_id