Toraco Abdominal AneurysmTVACNCT03512470
Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the "PREVENA" System
A study testing Sistema Prevena ™(TVAC) and Standard medication in people with Toraco Abdominal Aneurysm, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toraco Abdominal Aneurysm
- What is being tested?
- Sistema Prevena ™(TVAC) and Standard medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 24 Apr 2018to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients with established sepsis;
- patients with septic recurrence;
- patients with sensitivity to silver.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Toraco Abdominal Aneurysm
- Being tested
- Sistema Prevena ™(TVAC), Standard medication
- Keywords
- surgical wound, Prevena System
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sistema Prevena ™(TVAC)Device
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.
Standard medicationOther
standard medication in use (sterile gauze and TNT patch or medicated patches).
| Study group | Role | What they receive |
|---|---|---|
| Sistema Prevena ™ (TVAC) | Experimental | Negative topical pressure system (Sistema Prevena ™). Receives: Device: Sistema Prevena ™(TVAC) |
| Standard medication | Active comparator | Standard medication with sterile gauzes and a TNT patch or medicated patch Receives: Other: Standard medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of surgical site infections
Decrease in the percentage of surgical site infections and / or surgical wound dehiscence within 14 days of surgery
Measured: 14 days after surgery
Secondary outcomes (2)
Reduction of adverse events
decrease in the percentage of surgical reoperation
Measured: 12 month
Reduction of adverse events
decrease in the percentage of seromas / hematomas
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start24 Apr 2018
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Toraco Abdominal AneurysmStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baccellieri Domenico, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512470
- Sponsor's protocol ID
- 17/INT/2018
- Acronym
- TVAC
- Status last verified
- Dec 2023
- First submitted
- 19 Apr 2018
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005 Jan;51(1):28-34.
PubMed 15695833Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
PubMed 23312938Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
PubMed 40260835
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03512470
- Acronym / sponsor ID
- TVAC / 17/INT/2018
- Conditions
- Toraco Abdominal Aneurysm
- Keywords
- surgical wound, Prevena System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sistema Prevena ™ (TVAC) | Experimental | Device: Sistema Prevena ™(TVAC)Negative topical pressure system (Sistema Prevena ™). |
| Standard medication | Active comparator | Other: Standard medicationStandard medication with sterile gauzes and a TNT patch or medicated patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- patients with established sepsis;
- patients with septic recurrence;
- patients with sensitivity to silver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sistema Prevena ™ (TVAC) |
| Standard medicationstandard medication in use (sterile gauze and TNT patch or medicated patches). | Other | Standard medication |
Primary outcome
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
2 secondary outcomes
Reduction of adverse events
Time frame: 12 month
Reduction of adverse events
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 15695833Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005 Jan;51(1):28-34.
- Background: PubMed 23312938Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
- Derived from this study: PubMed 40260835Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sistema Prevena ™(TVAC) and Standard medication in people with Toraco Abdominal Aneurysm, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of surgical site infections (time frame: 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.