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
About this trial
This is an interventional prevention trial for Infection, Surgical Site
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.
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
NCT ID
NCT05247086
First Posted
February 9, 2022
Last Updated
February 9, 2022
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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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