Infected Surgical Wound
Conditions
Keywords
Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite
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%.
Interventions
DEVICEPTNiA
DEVICEPTNiB
DEVICEPTN
Sponsors
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient's pain (Numeric Rating Scale (NRS) | 1 month | assessment with Numeric Rating Scale (NRS) |
Countries
Italy
Contacts
Primary ContactPaolo Chiari
Backup ContactAngela Peghetti
Outcome results
None listed