Negative Pressure Therapy After Infected Mesh Removal.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection, Surgical Site

Intervention / Treatment
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* Device: Negative pressure therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Convention closure<br>Conventional closure of the surgical wound after mesh removal surgery. | |
| Experimental: Negative pressure therapy<br>Negative pressure therapy of the surgical wound after mesh removal surgery. | Device: Negative pressure therapy<br>* After surgical wound closure we will apply negative pressure therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Differences between surgical site infection between conventional closure vs negative pressure therapy | 30 days |