Infection, Surgical SiteICROMANCT05247086
Negative Pressure Therapy After Infected Mesh Removal.
A study testing Negative pressure therapy in people with Infection, Surgical Site, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- Negative pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender, adult. Age minimum limits 18.
- Infected chronic mesh.
- Signing of informed consent.
Who cannot join
- Enterocutaneous fistula or enteroatmospheric fistula.
- Infected chronic mesh related to parastomal hernia.
- Patients who will no complete the follow-up period.
- Informed consent denial.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection, Surgical Site
- Being tested
- Negative pressure therapy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure therapyDevice
After surgical wound closure we will apply negative pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Negative pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Differences between surgical site infection between conventional closure vs negative pressure therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247086
- Sponsor's protocol ID
- ICROMA PROJECT
- Acronym
- ICROMA
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol will be shared by internal email with other researchers, they should approve the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT05247086
- Acronym / sponsor ID
- ICROMA / ICROMA PROJECT
- Conditions
- Infection, Surgical Site
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convention closure | No intervention | –Conventional closure of the surgical wound after mesh removal surgery. |
| Negative pressure therapy | Experimental | Device: Negative pressure therapyNegative pressure therapy of the surgical wound after mesh removal surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any gender, adult. Age minimum limits 18.
- Infected chronic mesh.
- Signing of informed consent.
Key exclusion criteria (4 listed)
- Enterocutaneous fistula or enteroatmospheric fistula.
- Infected chronic mesh related to parastomal hernia.
- Patients who will no complete the follow-up period.
- Informed consent denial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure therapyAfter surgical wound closure we will apply negative pressure therapy | Device | Negative pressure therapy |
Primary outcome
Surgical site infection
Time frame: 30 days
Differences between surgical site infection between conventional closure vs negative pressure therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No. The protocol will be shared by internal email with other researchers, they should approve the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure therapy in people with Infection, Surgical Site, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.