Prevention of Surgical Wound Infection

NCT ID: NCT03905213

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-08-28

Brief Summary

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To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

Detailed Description

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It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized in three groups
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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conventional gauze

Device is a conventional gauze and the change will be to the day 2 and 4 of surgery

Group Type ACTIVE_COMPARATOR

dressing MEPORE

Intervention Type DEVICE

assignation to three different authorised and on label dressing: conventional dressing (MEPORE)

polyurethane dressing

Device is a polyurethane dressing and the change will be to the day 7 of surgery

Group Type EXPERIMENTAL

dressing MEPILEX

Intervention Type DEVICE

assignation to three different authorised and on label dressing: absorbent(MEPILEX)

vacuum therapy dressing

Device is a vacuum therapy dressing and the change will be to the day 7 of surgery

Group Type EXPERIMENTAL

dressing PICCO

Intervention Type DEVICE

assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)

Interventions

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dressing MEPORE

assignation to three different authorised and on label dressing: conventional dressing (MEPORE)

Intervention Type DEVICE

dressing MEPILEX

assignation to three different authorised and on label dressing: absorbent(MEPILEX)

Intervention Type DEVICE

dressing PICCO

assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient scheduled to cardiac surgery.
* signed informed consent form

Exclusion Criteria

* hypersensibility to dressings
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Maria Jesus Perez

OTHER

Sponsor Role lead

Responsible Party

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Maria Jesus Perez

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maria Jesus Perez Granda, PhD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Central Contacts

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Maria Jesus Perez Granda, PhD

Role: CONTACT

+34618355299

francisco Javier Hortal, PhD

Role: CONTACT

+34915868377

References

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Perez-Granda MJ, Cuerpo G, Barrio JM, Valerio M, Munoz P, Pinto AG, Valencia DE, Vicario FS, Bouza E; Cardiovascular Infection Study Group. A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery. Sci Rep. 2025 Jun 6;15(1):19960. doi: 10.1038/s41598-025-02533-7.

Reference Type DERIVED
PMID: 40481025 (View on PubMed)

Other Identifiers

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MICRO.HGUGM.2018-008

Identifier Type: -

Identifier Source: org_study_id

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