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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
Toraco Abdominal Aneurysm
Interventions
DEVICE

Sistema Prevena ™(TVAC)

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.

OTHER

Standard medication

standard medication in use (sterile gauze and TNT patch or medicated patches).

Trial Locations (1)

20132

San Raffaele Hospital, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER

NCT03512470 - "Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the PREVENA System" | Biotech Hunter | Biotech Hunter