The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.

Wound Infection Clinical Trial

Official title:

The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02195310
• Other study ID #: KCI.2013.Prevena.01
• Status: Terminated
• Phase: N/A
• Start date: November 12, 2013
• Est. completion date: October 17, 2016

Study information

• Verified date: April 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 342
• Est. completion date: October 17, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Occurences After Sternotomy
• Wound Infection

Intervention

Device:
• Prevena™ Incision Management System
Prevena™ Incision Management System is used after sternotomy on the closed incision
• Conventional sterile wound dressings
Conventional sterile wound dressings are placed after sternotomy on the closed incision

Locations

Country	Name	City	State
Austria	Medizinische Universitat Graz	Graz
Austria	Clinical Research Center Salzburg GmbH	Salzburg
Austria	Medizinische Universitaet Wien, Universitätsklinik für Chirurgie	Vienna
Germany	Charité Berlin	Berlin
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Westfälische Wilhelms-Universität Münster	Münster
Germany	Klinikum Nürnberg	Nurnberg
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Stichting St. Antonius ziekenhuis	Nieuwegein	Utrecht
Netherlands	Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam	Rotterdam	Zuid-Holland
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
3M	KCI Europe Holding B.V.

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 ± 4 days