Surgical Site Occurences After Sternotomy, Wound Infection
Conditions
Keywords
Sternotomy, Surgical site Occurences, Negative Pressure Wound Therapy, Surgical Site Infection
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.
Interventions
Prevena™ Incision Management System is used after sternotomy on the closed incision
DEVICEConventional sterile wound dressings
Conventional sterile wound dressings are placed after sternotomy on the closed incision
Sponsors
KCI Europe Holding B.V.
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines. | 30 ± 4 days | 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 |
Countries
Austria, Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevena™ Incision Management System Subjects will receive sternal wound treatment in the operating room with Prevena™ IMS according to the intended use
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision | 173 |
| Conventional Sterile Wound Dressings Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze)
Conventional sterile wound dressings are placed after sternotomy on the closed incision | 169 |
| Total | 342 |
Baseline characteristics
| Characteristic | Conventional Sterile Wound Dressings | Total | Prevena™ Incision Management System |
|---|---|---|---|
| Age, Continuous | 65.45 years STANDARD_DEVIATION 10.304 | 66.29 years STANDARD_DEVIATION 9.819 | 67.1 years STANDARD_DEVIATION 9.279 |
| Region of Enrollment Austria | 25 participants | 49 participants | 24 participants |
| Region of Enrollment Germany | 74 participants | 148 participants | 74 participants |
| Region of Enrollment Netherlands | 70 participants | 145 participants | 75 participants |
| Sex: Female, Male Female | 70 Participants | 149 Participants | 79 Participants |
| Sex: Female, Male Male | 99 Participants | 193 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 85 / 173 | 96 / 169 |
| serious Total, serious adverse events | 63 / 173 | 55 / 169 |
Outcome results
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
Time frame: 30 ± 4 days
Population: Full Analysis Set: Included Subjects in the ITT Analysis Set that had no important disqualifying protocol deviations, who met the inclusion/exclusion criteria, and had completed SSI evaluations at visit 5 (Follow-up Day 30). Subjects were analyzed in the arm to which they were treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena™ Incision Management System | Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines. | 9.0 percentage of participants |
| Conventional Sterile Wound Dressings | Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines. | 10.4 percentage of participants |
p-value: 0.7007Fisher Exact Test (2-sided)