NCT03512470: TVAC

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

Completed NA Last updated 26 December 2023

What this trial tests

NA trial testing Sistema Prevena ™(TVAC) in Toraco Abdominal Aneurysm in 100 participants. Completed in 30 November 2023.

Timeline

24 April 2018

Primary endpoint
30 November 2023

30 November 2023

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	24 April 2018
Primary completion	30 November 2023
Estimated completion	30 November 2023
Sites	1 location across Italy

Drugs / interventions tested

• Sistema Prevena ™(TVAC)
• Standard medication — full drug profile →

Conditions studied

• Toraco Abdominal Aneurysm — all drugs for Toraco Abdominal Aneurysm →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Toraco Abdominal Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Webster J, Liu Z, Norman G, Dumville JC, et al · · 2019 · cited 73× · PMID 30912582 · DOI 10.1002/14651858.cd009261.pub4
2. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Shi C, Goh EL, Murphy EM, et al · · 2022 · cited 71× · PMID 35471497 · DOI 10.1002/14651858.cd009261.pub7
3. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 48× · PMID 32542647 · DOI 10.1002/14651858.cd009261.pub6
4. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 38× · PMID 32356396 · DOI 10.1002/14651858.cd009261.pub5
5. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction.
   Cristino MA, Nakano LC, Vasconcelos V, Correia RM, et al · · 2025 · cited 2× · PMID 40260835 · DOI 10.1002/14651858.cd015192.pub2