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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    200
  • sponsor
    IRCCS San Raffaele
Updated on 4 September 2021

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).

Details
Condition Toraco Abdominal Aneurysm
Treatment Standard Medication, Sistema Prevena ™(TVAC)
Clinical Study IdentifierNCT03512470
SponsorIRCCS San Raffaele
Last Modified on4 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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