Negative Pressure Therapy After Infected Mesh Removal.

NCT05247086 | Unknown

• 1 other identifier: ICROMA PROJECT
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection, Surgical Site

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Differences between surgical site infection between conventional closure vs negative pressure therapy

  30 days

Study Arms (2)

Convention closure

NO INTERVENTION

Conventional closure of the surgical wound after mesh removal surgery.

Negative pressure therapy

EXPERIMENTAL

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

Device: Negative pressure therapy

Interventions

Negative pressure therapy DEVICE

After surgical wound closure we will apply negative pressure therapy

Negative pressure therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender, adult. Age minimum limits 18.
• Infected chronic mesh.
• Signing of informed consent.

You may not qualify if:

• Enterocutaneous fistula or enteroatmospheric fistula.
• Infected chronic mesh related to parastomal hernia.
• Patients who will no complete the follow-up period.
• Informed consent denial.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share