The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Primary Purpose
Surgical Site Occurences After Sternotomy, Wound Infection
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Prevena™ Incision Management System
Conventional sterile wound dressings
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Site Occurences After Sternotomy focused on measuring Sternotomy, Surgical site Occurences, Negative Pressure Wound Therapy, Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Medizinische Universitat Graz
- Clinical Research Center Salzburg GmbH
- Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
- Deutsches Herzzentrum Berlin
- Charité Berlin
- Universitätsklinikum Erlangen
- Westfälische Wilhelms-Universität Münster
- Klinikum Nürnberg
- Catharina Ziekenhuis Eindhoven
- Isala Klinieken
- Stichting St. Antonius ziekenhuis
- Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prevena™ Incision Management System
Conventional sterile wound dressings
Arm Description
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).
Outcomes
Primary Outcome Measures
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
The SSI rate (in %) was calculated for each treatment arm as follows:
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
Secondary Outcome Measures
Full Information
NCT ID
NCT02195310
First Posted
July 16, 2014
Last Updated
April 6, 2023
Sponsor
3M
Collaborators
KCI Europe Holding B.V.
1. Study Identification
Unique Protocol Identification Number
NCT02195310
Brief Title
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Official Title
The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
due to futility
Study Start Date
November 12, 2013 (Actual)
Primary Completion Date
August 15, 2016 (Actual)
Study Completion Date
October 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
KCI Europe Holding B.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The study is conducted in The Netherlands, Germany and Austria.
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 infection.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). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that delivers negative pressure and a dressing that is intended for use over closed incisions after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is commercially available and has a CE mark, which means that it is approved for the use on the European market. It is intended to be applied immediately post sternotomy surgery on a closed clean incision.
The results of this study could contribute to a better and faster healing of the incision.
The study is conducted in The Netherlands, Germany and Austria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Occurences After Sternotomy, Wound Infection
Keywords
Sternotomy, Surgical site Occurences, Negative Pressure Wound Therapy, Surgical Site Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevena™ Incision Management System
Arm Type
Experimental
Arm Description
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Arm Title
Conventional sterile wound dressings
Arm Type
Active Comparator
Arm Description
Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).
Intervention Type
Device
Intervention Name(s)
Prevena™ Incision Management System
Other Intervention Name(s)
Prevena Peel & Place
Intervention Description
Prevena™ Incision Management System is used after sternotomy on the closed incision
Intervention Type
Device
Intervention Name(s)
Conventional sterile wound dressings
Intervention Description
Conventional sterile wound dressings are placed after sternotomy on the closed incision
Primary Outcome Measure Information:
Title
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
Description
The SSI rate (in %) was calculated for each treatment arm as follows:
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
Time Frame
30 ± 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanasie Markou, MD, PhD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitat Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Clinical Research Center Salzburg GmbH
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Charité Berlin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Westfälische Wilhelms-Universität Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nurnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Stichting St. Antonius ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
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