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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduction of surgical site infections
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sistema Prevena ™ (TVAC)
Negative topical pressure system (Sistema Prevena ™).
Intervention: Sistema Prevena ™(TVAC) (Device)
Standard medication
Standard medication with sterile gauzes and a TNT patch or medicated patch
Intervention: Standard medication (Other)
Outcomes
Primary Outcomes
Reduction of surgical site infections
Time Frame: 14 days after surgery
Decrease in the percentage of surgical site infections and / or surgical wound dehiscence within 14 days of surgery
Secondary Outcomes
- Reduction of adverse events(12 month)
Investigators
Baccellieri Domenico
Principal Investigator
IRCCS San Raffaele