Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the PREVENA System

Study Overview
=================
Brief Summary
-----------------
The patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm (control group) will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use. The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).

Official Title
-----------------
A Clinical Study, Spontaneous, Randomized and Controlled, on the Prevention of Surgical Wound Complications for Aneurysmal Thoracoabdominal Aortic Disease by Using the PREVENA ™ Negative Topical Pressure System (TVAC STUDY)

Conditions
-----------------
Toraco Abdominal Aneurysm

Intervention / Treatment
-----------------
* Device: Sistema Prevena ™(TVAC)
* Other: Standard medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years; patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study. patients with surgical wounds to treat thoracic-abdominal aortic pathology. Exclusion Criteria: patients with established sepsis; patients with septic recurrence; patients with sensitivity to silver.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sistema Prevena ™ (TVAC)<br>Negative topical pressure system (Sistema Prevena ™). | Device: Sistema Prevena ™(TVAC)<br>* The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter medication will be checked in the inpatient ward after 48 h from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed and renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery.<br>|
| Active Comparator: Standard medication<br>Standard medication with sterile gauzes and a TNT patch or medicated patch | Other: Standard medication<br>* standard medication in use (sterile gauze and TNT patch or medicated patches).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of surgical site infections | Decrease in the percentage of surgical site infections and / or surgical wound dehiscence within 14 days of surgery | 14 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of adverse events | decrease in the percentage of surgical reoperation | 12 month | 
| Reduction of adverse events | decrease in the percentage of seromas / hematomas | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical wound, Prevena System