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

San Donato Group (GSD)

Status: Completed

Conditions: Toraco Abdominal Aneurysm

Treatments: Device: Sistema Prevena ™(TVAC); Other: Standard medication

Study type: Interventional

Funder types: Other

Identifiers

NCT03512470

17/INT/2018

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sistema Prevena ™ (TVAC)

Experimental group

Description:

Negative topical pressure system (Sistema Prevena ™).

Treatment:

Device: Sistema Prevena ™(TVAC)

Standard medication

Active Comparator group

Description:

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

Treatment:

Other: Standard medication