D-PLEX100:
Let The Recovery Begin
A first-in-class incisional SSI prophylactic therapy engineered to extend protection throughout the critical postoperative recovery period.
Scientific Publications
Closing the Postoperative Infection Gap
Today, surgical excellence and patient recovery remain vulnerable to surgical site infections (SSIs), with no targeted defense at the surgical incision site. SSIs continue to be among the most prevalent and costly hospital-acquired infections, despite widespread adherence by surgeons and hospitals to stringent infection prevention protocols. The CDC estimates that the annual cost burden of SSIs to the healthcare system ranges from
$3.3 billion to $10 billion.
While systemic prophylactic antibiotics are widely used as the standard of care, they are fundamentally limited in their ability to protect the surgical incision. Once an incision is made, local vascular disruption impairs systemic antibiotic penetration, leaving patients vulnerable during the most critical phases of surgery and postoperative recovery.
Better Outcomes by Design
D-PLEX100 was specifically designed to overcome the inherent limitations of systemic antibiotic prophylaxis. It delivers
broad-spectrum antibiotic protection when applied directly at the surgical wound through continuous, controlled release for 30 days at the incision site, reducing surgical site infections and
infection-related complications and improving clinical outcomes throughout the postoperative recovery period.
D-PLEX100 enhances the performance of the standard of care by adding a targeted, localized layer of protection at the incision site. By complementing systemic antibiotics, it closes a critical gap in surgical site infection prevention.
Proven Clinical Results
D-PLEX100 is supported by the largest surgical site infection (SSI) prevention program of its kind, including two large Phase 3 clinical trials involving more than 2,000 patients across over 40
surgical centers.
In the SHIELD II study, D-PLEX100 demonstrated a statistically significant 60% reduction in incisional SSIs compared with
standard of care alone (p=0.0013). The therapy works against both
Gram-positive and Gram-negative bacteria and is designed to integrate seamlessly into the surgical workflow through a single, simple intraoperative application.
By preventing infections before they take hold, D-PLEX100 addresses one of the most significant barriers to successful surgical recovery, leading to fewer complications, reduced hospital length of stay, fewer readmissions, and the potential for more predictable recovery, benefiting patients, empowering surgeons, and adding meaningful value across healthcare systems.
FDA Breakthrough Designation
D-PLEX100 was granted FDA Fast Track, Breakthrough Therapy, and QIDP designations, underscoring its clinical importance and innovative impact.
How Does It Work?
1. Active drug is stored in between the PLEX layers
of lipids and polymers.
2. Drug is released over time by the gradual
disintegration of the layers.
3. Effective drug release for durations ranging
from several days to several months.
FAQs
What was D-PLEX100 tested for in Phase 3 clinical trials?
D-PLEX100 was evaluated for the prevention of abdominal colorectal surgical site infections (SSIs) through localized, high-concentration doxycycline delivery for 30 days.
How is D-PLEX100 administered?
D-PLEX100 is applied as a paste along the entire length and depth of the surgical wound including the fascial suture line, subcutaneous tissue, and dermis prior to incision closure.
How is D-PLEX100 dosed?
The dose of D-PLEX100 is determined at the time of wound closure and is based on the length of the surgical incision.
How does D-PLEX100 differ from systemic antibiotics?
Systemic antibiotics are unable to sustain therapeutic concentrations at the surgical incision beyond a few hours, whereas D-PLEX100 provides controlled, localized antibiotic exposure at the incision site for 30 days.
Has D-PLEX100 been clinically validated?
Yes. D-PLEX100 demonstrated a highly statistically significant 60% reduction in surgical site infections in the Phase 3 SHIELD II clinical trial.
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