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The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTNiA | Experimental | Topical negative pressure therapy with instillation of saline solution (6 times daily). During the instillation of saline solution, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
|
| PTNiB | Experimental | Topical negative pressure therapy with instillation of Amukine Med 0,05% (6 times daily). During the instillation of Amukine Med 0,05%, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
|
| PTN | Active Comparator | Topical negative pressure therapy (without instillation). The device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNiA | Device |
| ||
| PTNiB |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of clinical infection (according NHSN 2014) | frequency of wound without clinical infection | 1 month |
| Absence of clinical infection | number of days to absence clinical infection | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment days | number of days to wounds treatment | 1 month |
| Wound closure | number of days to wounds closure | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Chiari | Contact | paolo.chiari@aosp.it | ||
| Angela Peghetti | Contact | angela.peghetti@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Chiari | Policlinico Sant'Orsola Malpighi Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola Malpighi | Recruiting | Bologna | Bologna | 40138 | Italy |
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|
| PTN | Device |
|
| Patient's discharge | number of days to patient's discharge | participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
| Patient's pain (Numeric Rating Scale (NRS) | assessment with Numeric Rating Scale (NRS) | 1 month |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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