Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

Study Overview
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Brief Summary
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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%.

Official Title
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Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

Conditions
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Infected Surgical Wound

Intervention / Treatment
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* Device: PTNiA
* Device: PTNiB
* Device: PTN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with infected surgical wounds. Patient age greater than or equal to 18 years. Patients who have given informed consent to the enrollment in the trial and to the processing of personal data. Exclusion Criteria: Patients unable of consent. Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation. Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen. Patients with malignancy at the wound. Patients with untreated osteomyelitis. Patients with enteric and unexplored fistulas. Patients with necrotic tissue and eschar. Immunocompromised patients or in treatment with corticosteroids. Suspected or known allergic diathesis to the product of medication. Patients with coagulation disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTNiA<br>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). | Device: PTNiA<br> <br> |
| Experimental: PTNiB<br>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). | Device: PTNiB<br> <br> |
| Active Comparator: PTN<br>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). | Device: PTN<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment days | number of days to wounds treatment | 1 month | 
| Wound closure | number of days to wounds closure | 1 month | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite