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

Toraco Abdominal Aneurysm Clinical Trial

— TVAC  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512470
• Other study ID #: 17/INT/2018
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm, Abdominal
• Surgical Wound
• Toraco Abdominal Aneurysm

Intervention

Device:
• 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.

Other:
• Standard medication
standard medication in use (sterile gauze and TNT patch or medicated patches).

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of adverse events	decrease in the percentage of surgical reoperation	12 month
Secondary	Reduction of adverse events	decrease in the percentage of seromas / hematomas	12 month