Status:
TERMINATED
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
KCI Europe Holding B.V.
3M
Conditions:
Surgical Site Occurences After Sternotomy
Wound Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy)....
Detailed Description
The Prevena™ IMS is intended to manage the environment of closed surgically incision and surrounding intact skin for patients with an increased risk for developing post-operative complications such as...
Eligibility Criteria
Inclusion
- Is male or female and 18 years of age or older
- Is scheduled for elective cardiac surgery for which a median sternotomy is needed (including coronary artery bypass grafting (CABG), valvular repair or replacement with or without CABG). Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- Is capable of providing informed consent, which must be obtained prior to any study-related procedures
- Is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Is pregnant
- The use of Prevena post surgery is contra indicated per investigator's discretion
- Has a systemic infection at the time of surgery: systemic infection is diagnosed on the basis of clinical signs of sepsis with or without a positive culture of an organism from the bloodstream
- Has a remote body site infection at the time of surgery (including dental, urinary or skin soft tissue infections)
- Is known to have a current nasal swab positive for methicillin-resistant staphylococcus aureus (MRSA)
- Has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
- Has a requirement for competing wound therapy and procedures.
- Any concomitant therapies (including other NPWT treatment) or procedures deviating from the clinical standard incision treatment or with investigational device at the location of the sternotomy (e.g. use of NPWT at other location of the body is allowed)
- Any other therapies or procedures that, in the opinion of the treating physician, would affect or influence postoperative wound stability or healing
- Is simultaneously participating in another interventional trial
- Requires use of liquid skin adhesives or glues during skin closure
- Is known to be serology positive for hepatitis B, hepatitis C or HIV
Key Trial Info
Start Date :
November 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2016
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT02195310
Start Date
November 12 2013
End Date
October 17 2016
Last Update
October 2 2024
Active Locations (13)
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1
Medizinische Universitat Graz
Graz, Austria, 8036
2
Clinical Research Center Salzburg GmbH
Salzburg, Austria, 5020
3
Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
Vienna, Austria, A-1090
4
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353