Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
Phase 3
- Conditions
- Infected Surgical Wound
- Interventions
- Device: PTNDevice: PTNiADevice: PTNiB
- Registration Number
- NCT02500875
- Brief Summary
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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTN PTN 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). PTNiA PTNiA 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 PTNiB 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).
- Primary Outcome Measures
Name Time Method Absence of clinical infection (according NHSN 2014) 1 month frequency of wound without clinical infection
Absence of clinical infection 1 month number of days to absence clinical infection
- Secondary Outcome Measures
Name Time Method Patient's pain (Numeric Rating Scale (NRS) 1 month assessment with Numeric Rating Scale (NRS)
Treatment days 1 month number of days to wounds treatment
Wound closure 1 month number of days to wounds closure
Patient's discharge participants will be followed for the duration of hospital stay, an expected average of 5 weeks number of days to patient's discharge
Trial Locations
- Locations (1)
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy