Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.
This is Phase III study to evaluate the anti-infective efficacy and safety of D-PLEX, a new formulation of extended release of Doxycycline, over a period of 3 months post operation by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. Study will be conducted in about 45 sites in US (about 15 sites), Europe and Israel, recruitment period will last about 18 months. D-PLEX will be administered as a single application. For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. For subjects randomized to the control arm, the surgical treatment will be as per the SOC. Pre- and post-operative care for both arms will be performed per site SOC. Patients will followed-up during 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2
D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)
The SOC prophylactic antibiotic treatment will be consistent and standardized for all sites in the clinical study. is based on "The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice."
Mayo Clinic
Rochester, Minnesota, United States
Memorial Hermann
Huston, Texas, United States
Soroka Medical Center
Beersheba, Israel
Number of Participants With a Sternal Wound Infection Event
Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018
Time frame: within 90 days (3 months) post sternotomy for cardiac surgery
Hospitalization Days
Number of Hospitalization days post sternotomy due to sternal infection.
Time frame: within 90 days (3 months) post sternotomy for cardiac surgery
Surgical Re-interventions
Number of Surgical re-interventions due to sternal surgical site infection.
Time frame: 90 days (3 months) post sternotomy
ASEPSIS Assessment Score
ASEPSIS is acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection. Parameters and Scores: Serous discharge \& Erythema will be marked between 0 - 5. Purulent exudate \& Separation of deep tissue are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound. Additional antibiotic treatment, a requirement for pus drainage, isolation of bacteria \& stay duration as an inpatient are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others. The final score can be in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection.
Time frame: 90 days (3 month) post sternotomy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.