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Completed

NCT Number: NCT03512470

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 medication

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Reduction of adverse events

    Time frame: 12 month

    decrease in the percentage of surgical reoperation

  2. Reduction of adverse events

    Time frame: 12 month

    decrease in the percentage of seromas / hematomas

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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)

Acronym: TVAC

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2018
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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