Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the "PREVENA" System
NCT ID: NCT03512470
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-04-24
2023-11-30
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sistema Prevena ™ (TVAC)
Negative topical pressure system (Sistema Prevena ™).
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.
Standard medication
Standard medication with sterile gauzes and a TNT patch or medicated patch
Standard medication
standard medication in use (sterile gauze and TNT patch or medicated patches).
Interventions
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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.
Standard medication
standard medication in use (sterile gauze and TNT patch or medicated patches).
Eligibility Criteria
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Inclusion Criteria
* 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 septic recurrence;
* patients with sensitivity to silver.
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Baccellieri Domenico
Principal Investigator
Locations
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San Raffaele Hospital
Milan, , Italy
Countries
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References
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Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005 Jan;51(1):28-34.
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.
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.
Other Identifiers
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17/INT/2018
Identifier Type: -
Identifier Source: org_study_id