D-PLEX for Surgical Site Infection
(D-PLEX312 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken certain antibiotics or anti-cancer treatments recently. It's best to discuss your specific medications with the trial team.
Is D-PLEX safe for use in humans?
D-PLEX has been shown to be safe in previous studies involving adult humans, swine, and rabbits, with no evidence of systemic safety concerns or local toxicity at the incision site. It is currently being evaluated in clinical trials for its safety and efficacy in preventing surgical site infections.12345
How is the drug D-PLEX different from other treatments for surgical site infections?
What data supports the effectiveness of the drug D-PLEX for preventing surgical site infections?
Research shows that D-PLEX, which releases the antibiotic doxycycline at the surgical site, significantly reduces infection rates in surgeries. In studies, it lowered bacterial loads and infection rates compared to standard care, even against resistant bacteria, making it a promising option for preventing surgical site infections.12345
Are You a Good Fit for This Trial?
Adults over 18, undergoing elective colorectal surgery with a large incision, who are stable before the operation and expected to live at least 60 days after. Women must not be pregnant and agree to birth control. Excludes those with recent abdominal surgeries or infections, severe allergies, liver/kidney issues, or active cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Treatment
D-PLEX is applied during the surgery at the final stage of incision closure
Follow-up
Participants are monitored for safety and incisional wound assessment, including blood tests and physician's assessment
What Are the Treatments Tested in This Trial?
Interventions
- D-PLEX
Find a Clinic Near You
Who Is Running the Clinical Trial?
PolyPid Ltd.
Lead Sponsor