Back to resultsSafety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Primary Purpose
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
D-PLEX
Open heart surgery
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Wound Infection Superficial Incisional focused on measuring Mediastenitis
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant female above 18 years old
Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study.
- Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
- Subjects with (20≤BMI≤40)
- Subjects who sign a written informed consent.
Exclusion Criteria:
- Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer).
Are ineligible to receive treatment with:
- Any preoperative active significant infection
- Antibiotic sensitivity to Doxycycline and/or tetracycline family of drugs
- Known allergies to more than 3 substances.(Patients should fill the allergy questioners during the enrolment process)
- History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic / hypersensitivity reactions.
- History of uncontrolled Asthma (GINA III-IV)
- History of chronic urticaria
- Pregnant or breastfeeding women.
- Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
- Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
- Immunocompromised subjects from any reason, at screening.
- Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
- Subjects that previously underwent any cardiac surgery through mid-sternum.
- In the opinion of investigator, subject is not eligible to participate in the study due to a cognitive status, medical condition or medication status (other than items listed above)
Sites / Locations
- Soroka Medical Center
- Rambam Medical Center
- Assuta Medical Center
- Sheba Medical Center
- Poriya Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment arm
Control arm
Arm Description
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
Outcomes
Primary Outcome Measures
Sternal Infection identified within 90 days post-cardiac surgery. Primary sternal infection as measured by the proportion of subjects with at least 1 identified primary sternal infection within 90 days post-cardiac surgery.
Decrease of infection rate as measured by the proportion of subjects with at least 1 identified sternal infection within 90 days post-cardiac surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02731573
Brief Title
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Official Title
A Phase Ib/II Prospective, Multicenter, Two Part Study; Part 1 - Open Label, Single Arm & Part 2 Randomized, Single-blinded (Study to Assess Safety and Efficacy of D-PLEX Concomitantly With Standard of Care vs. Standard of Care Alone in the Prevention of Primary Sternal Infection Post Cardiac Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyPid Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study.
Detailed Description
D-PLEX is a new formulation of extended controlled release Doxycycline.
Subjects who meet the eligibility criteria and provide signed informed consent, will be enrolled into the study and will be treated with D-PLEX concomitantly with standard of care.
D-PLEX will be administered as a single application during a cardiac surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
The study will assess the efficacy and safety of the controlled release antibiotic (doxycycline) by the reduction in the number of sternal infections observed during the treatment period in any subject above the age of 18 years, including patients with high risk for infection.
Additional follow up for prolonged safety assessments only, will be done as follows until 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Keywords
Mediastenitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase Ib/II, Prospective, Multicenter, Two part study; Part 1 Open Label, Single arm & Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
Study population include subjects above the age of 18 years, that undergoing cardiac surgery through mid-sternotomy, including patients with high risk of infection, such as diabetes (Insulin and/or non-insulin dependent), patients with Peripheral Vascular Disease (PVD), Chronic Obstructive Pulmonary Disease (COPD), heavy smokers, Bilateral Mammary artery harvesting, and subjects administered chronic steroid treatment.
Subjects who meet the eligibility criteria and provide signed informed consent, will be enrolled into the study and will be treated with D-PLEX concomitantly with standard of care (part 1) or randomized 2:1 to D-PLEX concomitantly with standard of care vs. standard of care only (part 2).
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
Arm Title
Control arm
Arm Type
Other
Arm Description
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
Intervention Type
Drug
Intervention Name(s)
D-PLEX
Intervention Description
D-PLEX will be administered as a single application during the open heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Intervention Type
Procedure
Intervention Name(s)
Open heart surgery
Other Intervention Name(s)
SOC
Intervention Description
Subject will undergo open heart surgery according to standard of care
Primary Outcome Measure Information:
Title
Sternal Infection identified within 90 days post-cardiac surgery. Primary sternal infection as measured by the proportion of subjects with at least 1 identified primary sternal infection within 90 days post-cardiac surgery.
Description
Decrease of infection rate as measured by the proportion of subjects with at least 1 identified sternal infection within 90 days post-cardiac surgery.
Time Frame
Within 90 days post-cardiac surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant female above 18 years old
Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study.
Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
Subjects with (20≤BMI≤40)
Subjects who sign a written informed consent.
Exclusion Criteria:
Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer).
Are ineligible to receive treatment with:
Any preoperative active significant infection
Antibiotic sensitivity to Doxycycline and/or tetracycline family of drugs
Known allergies to more than 3 substances.(Patients should fill the allergy questioners during the enrolment process)
History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic / hypersensitivity reactions.
History of uncontrolled Asthma (GINA III-IV)
History of chronic urticaria
Pregnant or breastfeeding women.
Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
Immunocompromised subjects from any reason, at screening.
Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
Subjects that previously underwent any cardiac surgery through mid-sternum.
In the opinion of investigator, subject is not eligible to participate in the study due to a cognitive status, medical condition or medication status (other than items listed above)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erez Kachel, MD
Organizational Affiliation
Sheba MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer sheva
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Poriya Medical Center
City
Tiberias
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
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