Negative Pressure Therapy After Infected Mesh Removal.

Not Applicable

• Conditions: Infection, Surgical Site
• Interventions: Device: Negative pressure therapy

• Registration Number: NCT05247086
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Study Start: 2023-01-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	Differences between surgical site infection between conventional closure vs negative pressure therapy