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Antibiotic

D-PLEX for Cardiac Surgery

Phase 3
Waitlist Available
Led By Hartzell V. Schaff, M.D.
Research Sponsored by PolyPid Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare the efficacy of D-PLEX given with a standard antibiotic regimen versus the standard antibiotic regimen alone in preventing post-operative sternal infections in high-risk patients. The study will enroll 630 patients at up to 90 sites globally, and will follow patients for a total of 90 days post-operatively. The primary efficacy endpoint is the number of patients with at least one clinically confirmed sternal infection within 90 days post-operatively.

Eligible Conditions
  • Cardiac Surgery
  • Sternal Infection
  • Surgical Site Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sternal Wound Infection rate
Secondary outcome measures
Average ASEPSIS assessment score
Deep Sternal Wound Infections (DSWI)
Determination of susceptibility to Doxycycline
+4 more
Other outcome measures
Analgesic treatment
Antibiotic treatment due to Sternal Surgical Site Infections (IV administration).
Antibiotic treatment due to Sternal Surgical Site Infections (all routes of administration).
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
For subjects randomized to the control arm, the surgical treatment will be as per the SOC.
Group II: D-PLEX + SOCExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-PLEX
2016
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

PolyPid Ltd.Lead Sponsor
6 Previous Clinical Trials
1,932 Total Patients Enrolled
Hartzell V. Schaff, M.D.Principal InvestigatorMayo Clinic, 220 First Street SW, Rochester, MN. 55902

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the associated risks with taking D-PLEX?

"D-PLEX received a safety score of 3 because there is already some clinical evidence for its efficacy and multiple trials that support its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
2019. "D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03558984.
~0 spots leftby Apr 2025
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