Trial Outcomes & Findings for The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences. (NCT NCT02195310)
NCT ID: NCT02195310
Last Updated: 2024-10-02
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
342 participants
Primary outcome timeframe
30 ± 4 days
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
Prevena™ Incision Management System
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
169
|
|
Overall Study
COMPLETED
|
153
|
153
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Baseline characteristics by cohort
| Measure |
Prevena™ Incision Management System
n=173 Participants
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
|
Conventional Sterile Wound Dressings
n=169 Participants
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
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 9.279 • n=99 Participants
|
65.45 years
STANDARD_DEVIATION 10.304 • n=107 Participants
|
66.29 years
STANDARD_DEVIATION 9.819 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
75 participants
n=99 Participants
|
70 participants
n=107 Participants
|
145 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
24 participants
n=99 Participants
|
25 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
74 participants
n=99 Participants
|
74 participants
n=107 Participants
|
148 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 ± 4 daysPopulation: 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.
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
Outcome measures
| Measure |
Prevena™ Incision Management System
n=145 Participants
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision
|
Conventional Sterile Wound Dressings
n=154 Participants
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
|
|---|---|---|
|
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
|
10.4 percentage of participants
|
Adverse Events
Prevena™ Incision Management System
Serious events: 63 serious events
Other events: 85 other events
Deaths: 0 deaths
Conventional Sterile Wound Dressings
Serious events: 55 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevena™ Incision Management System
n=173 participants at risk
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision
|
Conventional Sterile Wound Dressings
n=169 participants at risk
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: Conventional sterile wound dressings are placed after sternotomy on the closed incision
|
|---|---|---|
|
Cardiac disorders
Cardiac Tamponade
|
4.6%
8/173
|
1.8%
3/169
|
|
Cardiac disorders
Cardiogenic Shock
|
2.3%
4/173
|
1.2%
2/169
|
|
Cardiac disorders
Atrioventricular Block
|
0.58%
1/173
|
3.0%
5/169
|
|
Cardiac disorders
Pericardial Effusion
|
1.7%
3/173
|
0.59%
1/169
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/173
|
2.4%
4/169
|
|
Cardiac disorders
Ventricular Failure
|
1.2%
2/173
|
0.59%
1/169
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.2%
2/173
|
0.59%
1/169
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.2%
2/173
|
0.59%
1/169
|
|
Cardiac disorders
Atrial Fibrillation
|
0.58%
1/173
|
0.59%
1/169
|
|
Cardiac disorders
Cardiac Arrest
|
0.58%
1/173
|
0.59%
1/169
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.58%
1/173
|
0.59%
1/169
|
|
Cardiac disorders
Right Ventricular Failure
|
0.58%
1/173
|
0.59%
1/169
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/173
|
1.2%
2/169
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Left Ventricular Failure
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Ventricular Flutter
|
0.58%
1/173
|
0.00%
0/169
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/173
|
0.59%
1/169
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/173
|
0.59%
1/169
|
|
Cardiac disorders
Electromechanical Dissociation
|
0.00%
0/173
|
0.59%
1/169
|
|
Infections and infestations
Postoperative Infection
|
4.6%
8/173
|
5.9%
10/169
|
|
Infections and infestations
Pneumonia
|
1.7%
3/173
|
1.8%
3/169
|
|
Infections and infestations
Septic Shock
|
1.2%
2/173
|
0.59%
1/169
|
|
Infections and infestations
Groin Infection
|
1.2%
2/173
|
0.00%
0/169
|
|
Infections and infestations
Mediastinitis
|
0.58%
1/173
|
0.59%
1/169
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/173
|
1.2%
2/169
|
|
Infections and infestations
Infection
|
0.00%
0/173
|
1.2%
2/169
|
|
Infections and infestations
Acute Endocarditis
|
0.58%
1/173
|
0.00%
0/169
|
|
Infections and infestations
Cystitis
|
0.58%
1/173
|
0.00%
0/169
|
|
Infections and infestations
Empyema
|
0.58%
1/173
|
0.00%
0/169
|
|
Infections and infestations
Pneumonia Bacterial
|
0.58%
1/173
|
0.00%
0/169
|
|
Infections and infestations
Respiratory Tract Infection
|
0.58%
1/173
|
0.00%
0/169
|
|
Infections and infestations
Abscess
|
0.00%
0/173
|
0.59%
1/169
|
|
Infections and infestations
Cellulitis
|
0.00%
0/173
|
0.59%
1/169
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/173
|
0.59%
1/169
|
|
Infections and infestations
Mediastinal Abscess
|
0.00%
0/173
|
0.59%
1/169
|
|
Infections and infestations
Sepsis
|
0.00%
0/173
|
0.59%
1/169
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
3.5%
6/173
|
5.3%
9/169
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.58%
1/173
|
1.2%
2/169
|
|
Injury, poisoning and procedural complications
Dislocation of Sternum
|
1.2%
2/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.58%
1/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.58%
1/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Vascular Procedure Complication
|
0.58%
1/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.58%
1/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.58%
1/173
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Iatrogenic Injury
|
0.00%
0/173
|
0.59%
1/169
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.00%
0/173
|
0.59%
1/169
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/173
|
0.59%
1/169
|
|
Vascular disorders
Haemodynamic Instability
|
2.3%
4/173
|
1.2%
2/169
|
|
Vascular disorders
Haematoma
|
1.2%
2/173
|
0.59%
1/169
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.58%
1/173
|
0.59%
1/169
|
|
Vascular disorders
Haemorrhage
|
0.58%
1/173
|
0.00%
0/169
|
|
Vascular disorders
Ischaemia
|
0.58%
1/173
|
0.00%
0/169
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/173
|
0.59%
1/169
|
|
Vascular disorders
Vascular Insufficiency
|
0.00%
0/173
|
0.59%
1/169
|
|
General disorders
Multi-Organ Failure
|
1.2%
2/173
|
1.2%
2/169
|
|
General disorders
Impaired Healing
|
1.2%
2/173
|
0.00%
0/169
|
|
General disorders
Chest Pain
|
0.58%
1/173
|
0.59%
1/169
|
|
General disorders
Sudden Cardiac Death
|
0.58%
1/173
|
0.00%
0/169
|
|
General disorders
Sudden Death
|
0.00%
0/173
|
0.59%
1/169
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.3%
4/173
|
1.2%
2/169
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/173
|
1.2%
2/169
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.58%
1/173
|
0.00%
0/169
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.58%
1/173
|
0.00%
0/169
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.58%
1/173
|
0.00%
0/169
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.3%
4/173
|
0.59%
1/169
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/173
|
0.59%
1/169
|
|
Nervous system disorders
Dizziness
|
0.00%
0/173
|
0.59%
1/169
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.58%
1/173
|
0.00%
0/169
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.58%
1/173
|
0.00%
0/169
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.58%
1/173
|
0.00%
0/169
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/173
|
0.59%
1/169
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/173
|
0.00%
0/169
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.58%
1/173
|
0.00%
0/169
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/173
|
0.00%
0/169
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/173
|
0.59%
1/169
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.58%
1/173
|
1.8%
3/169
|
|
Psychiatric disorders
Delirium
|
1.2%
2/173
|
0.59%
1/169
|
|
Surgical and medical procedures
Rehabilitation Therapy
|
0.00%
0/173
|
0.59%
1/169
|
|
Surgical and medical procedures
Removal of Foreign Body
|
0.00%
0/173
|
0.59%
1/169
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.58%
1/173
|
0.00%
0/169
|
|
Eye disorders
Amaurosis Fugax
|
0.58%
1/173
|
0.00%
0/169
|
|
Immune system disorders
Anaphylactic Reaction
|
0.58%
1/173
|
0.00%
0/169
|
|
Investigations
C-Reactive Protein Increased
|
0.58%
1/173
|
0.00%
0/169
|
|
Reproductive system and breast disorders
Prostatitis
|
0.58%
1/173
|
0.00%
0/169
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.58%
1/173
|
0.00%
0/169
|
Other adverse events
| Measure |
Prevena™ Incision Management System
n=173 participants at risk
Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision
|
Conventional Sterile Wound Dressings
n=169 participants at risk
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: Conventional sterile wound dressings are placed after sternotomy on the closed incision
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
26.0%
45/173
|
25.4%
43/169
|
|
Cardiac disorders
Pericardial Effusion
|
16.2%
28/173
|
17.8%
30/169
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
20.2%
35/173
|
24.3%
41/169
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.8%
29/173
|
19.5%
33/169
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
13.9%
24/173
|
11.2%
19/169
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
5.2%
9/173
|
5.3%
9/169
|
|
Infections and infestations
Postoperative Infection
|
4.0%
7/173
|
5.3%
9/169
|
|
Infections and infestations
Lung Infection
|
5.2%
9/173
|
3.6%
6/169
|
|
General disorders
Oedema Peripheral
|
4.0%
7/173
|
7.1%
12/169
|
|
General disorders
Oedema
|
5.2%
9/173
|
3.0%
5/169
|
|
Psychiatric disorders
Psychotic Disorder
|
6.9%
12/173
|
8.3%
14/169
|
|
Psychiatric disorders
Delirium
|
4.6%
8/173
|
5.9%
10/169
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
11/173
|
4.7%
8/169
|
|
Investigations
C-Reactive Protein Increased
|
5.2%
9/173
|
11.2%
19/169
|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
10/173
|
14.2%
24/169
|
|
Surgical and medical procedures
Wound Drainage
|
5.8%
10/173
|
3.0%
5/169
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place