PURPOSE:     

• The purpose of the study is to determine the safety and effectiveness of REPEL-CV for reducing post-operative adhesions in patients undergoing cardiothoracic surgery.

BACKGROUND:  

• Adhesions are fibrous structures that connect tissues or organ surfaces that are not normally joined.  They are an undesirable side effect of the body’s normal healing process following damage to tissues.  Adhesions can cause significant complications following surgery (e.g., infertility, bowel obstruction, pain, etc.). 
• In cardiac surgery, adhesions can increase the complexity, duration and risk of subsequent surgery and sometimes can cause catastrophic sequelae.  Several approaches have been advocated for the purpose of reducing post-operative adhesions, including: reduction in trauma, anti-inflammatory agents, anti-coagulants, thrombolytic agents and the use of barriers.    
• Life Medical Sciences, Inc. has developed REPEL-CV, a bioresorbable barrier, as a surgical adjuvant for reducing the formation of post-operative cardiothoracic adhesions.  REPEL-CV is a sterile, bioresorbable polymeric barrier-film composed of polyethylene glycol and poly L- lactic acid.  REPEL-CV is absorbed from the site of implantation within 4 weeks of application.  REPEL-CV provides a temporary barrier to mechanically separate potentially opposing surfaces from interconnecting with each other during the early phases of the healing process.

CRITERIA FOR INCLUSION OF SUBJECTS:    

Patients must meet all the following criteria before they are eligible to enter the study:

• Patients requiring staged cardiovascular sternotomy procedures, no previous sternotomy, weight greater the 2.5 Kg.,   
• The patients are not required to be on the Heart-Lung bypass machine during the first procedure.  It is anticipated that the second sternotomy procedure will be performed two to eight months subsequent to the initial sternotomy procedure. 
• The patient is not a participant in another invasive device or drug study during the course of this study. 
• The legal representatives of the patient are willing to participate in the study and abide by its requirements. 
• The patient’s legal representative is willing and able to provide written informed consent.

CRITERIA FOR EXCLUSION OF SUBJECTS:

• Use of approved or unapproved treatments to prevent adhesions during the course of the study. 
• Use of Extracorporeal Membrane Oxygenation (ECMO) preoperatively, intraoperatively or before chest closure (patient does not qualify unless it is routinely used for this procedure at the respective Medical Center). 
• Patients will be excluded if there is placement of absorbable hemostats that continue to remain at the investigational surgical site at time of randomization and chest closure.   
• If there is a positive microbiology culture of the surgical site prior to randomization a patient will be excluded. 
• If there are more than 120 hours (5 days) between the times of the sternotomy to time of chest closure a patient will be excluded. 
• If there is evidence of thick, discolored or malodorous discharge in the wound; or other gross evidence of mediastinitis a patient will be excluded.  Additionally, if the pericardium closed prior to chest closure a patient will be excluded.

RECRUITMENT OF SUBJECTS:

• Investigators will recruit patients from Children’s Medical Center Dallas and Parkland Health & Hospital System.   

For more information, please contact Nicklett Johnston, R.N. at 214-645-7728.