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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional gauze | Active Comparator | Device is a conventional gauze and the change will be to the day 2 and 4 of surgery |
|
| polyurethane dressing | Experimental | Device is a polyurethane dressing and the change will be to the day 7 of surgery |
|
| vacuum therapy dressing | Experimental | Device is a vacuum therapy dressing and the change will be to the day 7 of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dressing MEPORE | Device | assignation to three different authorised and on label dressing: conventional dressing (MEPORE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| prevention of surgical wound infection | surgical wound infection measured as number of patients suffering surgical wound infection during the study period | surgery date up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| hospital stay | days at hospital | from hospitalization until an average of 1 year |
| antimicrobial consumption | defined dose of antimicrobial agents during hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Jesus Perez Granda, PhD | Contact | +34618355299 | massus@hotmail.es | |
| francisco Javier Hortal, PhD | Contact | +34915868377 | javier.hortal@gamil.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Jesus Perez Granda, PhD | Gregorio Marañón Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40481025 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 11, 2025 | |
| Reset | Sep 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 11, 2025 | Sep 30, 2025 |
randomized in three groups
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| dressing MEPILEX | Device | assignation to three different authorised and on label dressing: absorbent(MEPILEX) |
|
| dressing PICCO | Device | assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO) |
|
| from surgery date until an average of 1 year |
| dressing consumption cost | number of dressing and its cost | from surgery date until an average of 8 weeks |