Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
Phase: NA
Conditions: Surgical Wound Infection
Sponsor: Mayo Clinic

 
 
Negative Pressure Wound 
Therapy for Prevention of 
Wound Infection after Heart 
Surgery 
 
NCT# 02020018 
 
September 23, 2016 

 
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IRB 10272.001 rev. 20090612 
 
IRB Protocol Template 
 
 
Title:   Negative pressure wound therapy for prevention of wound infection after 
heart surgery 
 
Protocol Version/Date: September 23, 2016 
IRB#:    16-007901 (Original 13-001832) 
 
 
PI: 
Said, Sameh M.D. 
 
Abstract:     
Wound-related complications after median sternotomy are important problems associated with increased 
morbidity and mortality, and lead to increase costs secondary to increase length of hospital stay and the 
need for repeated surgical procedures in these patients. Risk factors include: chronic obstructive pulmonary 
disease (COPD), smoking, diabetes, bilateral harvest of the internal thoracic artery, and, in particular, 
obesity have been identified as major risk factors. Breakdown of skin sutures facilitates entry of bacteria into 
the deeper layers and presents the initial step in the development of the majority of wound infections after 
median sternotomy. This theory may explain why the risk of wound infection is particularly high in obese 
patients, because the shear and traction forces on skin sutures are high. Negative pressure wound therapy 
have been used in different specialities to treat infected or open wounds, and has been proven to be of great 
benefit in multiple studies. Its use as a primary prevention has not been the routine after cardiac surgery in 
high risk patients. We hypothesize that negative pressure wound dressing application on clean skin 
immediately after suturing in the operating room for 6-7 days will prevent skin breakdown in the early periods 
after surgery and will decrease the incidence of wound related complications and infection. This may lead to 
a change in practice when dealing with high risk individuals. The purpose of this study was to compare a 
new commercially available negative pressure wound therapy (NPWT) system (Prevena Incision 
Management System; KCI, San Antonio, Tex) and conventional sterile dry wound dressing in a high-risk 
group (ie, obese patients), with special regard to wound complications and infections. 
Of note the “Prevena incision management system” is an FDA-approved device with 510K clearance. 
 
Schematic Design of the Study: There will be two groups: the first will include “Prospective non-
randomized” part which will include patients who agreed to participate and have wound VAC applied to their 
incision postoperatively for 6-7 days (this information was collected under  IRB 13-001832).  The second 
group will include “retrospective chart review” for standard wound care after heart surgery with no wound 
VAC. 
       
Aims:  
 
Comparing the outcome of negative pressure wound therapy and conventional sterile dressing for high risk 
patients undergoing open heart surgery through median sternotomy  
 
Methods 
 
Description of Recruitment Methods:  
 
How will subjects be identified?   
Chart review and cardiac surgery database 
How will subjects be contacted?    
 
Follow-up routine postoperative visits and chart reviews  
 
Recruitment Materials (if applicable):  
 
Chart review  
Subject Population: 
 
 
Number: 950 
 
 
The prospective potion will include 300 patients in whom the Prevena wound VAC system 
will be applied and the retrospective portion will include the remaining 650 patients.  
 
                          Gender:   
Male 
 
450  
 
 

 
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IRB 10272.001 rev. 20090612 
Female  
500 
 
 
Ages:  18  to 100 years 
Inclusion Criteria:    
 
 
BMI>30 
 
Severe COPD 
 
Steroid-dependent 
 
Type-I diabetes (insulin-dependent) 
 
Heart and lung transplant patients 
 
Preoperative tracheostomy  
 
Undergoing median sternotomy for open heart surgery between 2013-2014 
Exclusion Criteria: 
 
 
Thoracotomy 
 
Type-II diabetes 
 
BMI<30 
Step-by-Step Schedule (include all procedures, therapies – attach a table or flow chart if there are multiple 
procedures or visits and indicate the window of number of days in which the participant may return for follow-up visits): 
N/A 
Biospecimen (types, number, volume, processing, storage): 
 
N/A 
Plan for Dose Modification if Toxicity occurs (if applicable):    
N/A 
 Statistical Considerations 
 
Endpoints 
 
 
Primary:  
wound infection  
 
 
 
Secondary:  
wound breakdown 
                                                    Length of stay 
                                                    Re-operation 
                                                    Mortality due to mediastinitis  
 
Protocol form, page 2 
 
Human Safety Aspects 
Risks:  Minimal risk study  
Individual Subject Stopping Rules (if applicable):          
DSMB (if applicable): 
Members:   
 
      
Charter:  
 
       
Stopping Rules for Efficacy and Safety (if applicable):      
      
Questionnaires that ask about Depression (if applicable) 
Included in study?    Yes 
   No  ▀If “Yes”, state the plan of management for subjects with possible 
depression: