NCT05247086

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Negative pressure therapy	After surgical wound closure we will apply negative pressure therapy

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2022-02-18
• Last updated: 2022-02-18