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

NCT03512470 | Completed

• 1 other identifier: 17/INT/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Toraco Abdominal Aneurysm

Keywords

surgical wound; Prevena System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduction of adverse events

  12 month

• Reduction of adverse events

  12 month

Study Arms (2)

Sistema Prevena ™ (TVAC)

EXPERIMENTAL

Negative topical pressure system (Sistema Prevena ™).

Device: Sistema Prevena ™(TVAC)

Standard medication

ACTIVE COMPARATOR

Standard medication with sterile gauzes and a TNT patch or medicated patch

Other: Standard medication

Interventions

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.

Sistema Prevena ™ (TVAC)

Standard medication OTHER

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

Standard medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients with established sepsis;
• patients with septic recurrence;
• patients with sensitivity to silver.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (3)

• Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005 Jan;51(1):28-34.

  PMID: 15695833 BACKGROUND

• Matatov 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.

  PMID: 23312938 BACKGROUND

• Cristino 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.

  PMID: 40260835 DERIVED

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: April 30, 2018
• Study Start: April 24, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)