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Negative Pressure Therapy After Infected Mesh Removal. (ICROMA)

Primary Purpose

Infection, Surgical Site

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Negative pressure therapy
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Surgical Site

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Convention closure

    Negative pressure therapy

    Arm Description

    Conventional closure of the surgical wound after mesh removal surgery.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2022
    Last Updated
    February 9, 2022
    Sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05247086
    Brief Title
    Negative Pressure Therapy After Infected Mesh Removal.
    Acronym
    ICROMA
    Official Title
    Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Surgical Site

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    94 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Convention closure
    Arm Type
    No Intervention
    Arm Description
    Conventional closure of the surgical wound after mesh removal surgery.
    Arm Title
    Negative pressure therapy
    Arm Type
    Experimental
    Arm Description
    Negative pressure therapy of the surgical wound after mesh removal surgery.
    Intervention Type
    Device
    Intervention Name(s)
    Negative pressure therapy
    Intervention Description
    After surgical wound closure we will apply negative pressure therapy
    Primary Outcome Measure Information:
    Title
    Surgical site infection
    Description
    Differences between surgical site infection between conventional closure vs negative pressure therapy
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The protocol will be shared by internal email with other researchers, they should approve the protocol.

    Learn more about this trial

    Negative Pressure Therapy After Infected Mesh Removal.

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