Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03558984|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection Open Heart Surgery||Drug: D-PLEX||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Eligible subjects will be randomized to either the treatment arm (D-PLEX + SOC prophylactic antibiotic treatment) or to control arm (SOC prophylactic antibiotic treatment only), in a 1:1 ratio.
Subjects will be blinded to the study arm.
|Masking Description:||Subjects will be blinded to the treatment arm assignment. The study site personnel present at the baseline procedure as well as the physician performing the procedure will be trained not to disclose the treatment arm to the subject, his/her family, to health care providers outside of the surgery department and to the study sponsor.|
|Official Title:||Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: D-PLEX + SOC
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.
D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)
No Intervention: Standard of Care
For subjects randomized to the control arm, the surgical treatment will be as per the SOC.
- Infection rate [ Time Frame: within 90 days (3 months) post sternotomy for cardiac surgery ]Infection rate as measured by the proportion of subjects with a sternal wound infection event
- Hospitalization days [ Time Frame: 90 days ]Average number of Hospitalization days post sternotomy for cardiac surgery, due to sternal infection.
- Deep Surgical Wound Infection (DSWI) rates [ Time Frame: 90 days (3 months) post sternotomy ]Incidence of DSWI rates
- Superficial Surgical Wound Infection (SSWI) rates [ Time Frame: 90 days (3 months) post sternotomy ]Incidence of SSWI rates
- Antibiotic Treatment [ Time Frame: 90 days (3 months) post sternotomy ]Average number of Antibiotic Treatment (overall IV and other administration modes, e.g. PO) days due to Sternal Surgical Site infection.
- Surgical re-interventions [ Time Frame: 90 days (3 months) post sternotomy ]Number of surgical re-interventions due to Sternal Surgical Site infection
- Mortality rate from any reason [ Time Frame: 6 months ]Mortality rate from any reason
- Mortality rate due to sternal wound infection [ Time Frame: 90 days (3 months) post sternotomy ]Mortality rate associated sternal wound infection.
- Overall hospitalization days [ Time Frame: 6 months ]Average number of Overall Hospitalization days post sternotomy for cardiac surgery, including days of readmission due to any reason.
- Antibiotic treatment IV [ Time Frame: 90 days (3 months) post sternotomy ]Average number of Antibiotic Treatment (IV) days due to Sternal Surgical Site infection (SSWI and DSWI).
- Time to sternal infection [ Time Frame: 90 days (3 months) post sternotomy ]Time to sternal wound infection (Post Operating Day) post sternotomy.
- Analgesic treatment [ Time Frame: 6 months ]Average number of analgesic treatment days
- Visual Analogue Score (VAS) assessment [ Time Frame: 6 months ]VAS score assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558984
|Contact: Ilana Sufaro||+972-74-7195700 ext +email@example.com|
|Contact: Noa Kirshenboim, PhD||+972-74-7195700 ext +firstname.lastname@example.org|
|Soroka Medical Center||Not yet recruiting|
|Beer Sheva, Israel|
|Contact: Adelina Steinberg 08-6400962 email@example.com|
|Study Director:||Noa Kirshenboim, PhD||VP Clinical|