Negative Pressure Therapy After Infected Mesh Removal. (ICROMA)

February 9, 2022 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICROMA PROJECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The protocol will be shared by internal email with other researchers, they should approve the protocol.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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