Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 94
- Primary Endpoint
- Surgical site infection
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any gender, adult. Age minimum limits
- •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.
Arms & Interventions
Convention closure
Conventional closure of the surgical wound after mesh removal surgery.
Negative pressure therapy
Negative pressure therapy of the surgical wound after mesh removal surgery.
Intervention: Negative pressure therapy (Device)
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: 30 days
Differences between surgical site infection between conventional closure vs negative pressure therapy
Secondary Outcomes
No secondary outcomes reported