D-PLEX for Surgical Site Infection

(D-PLEX312 Trial)

This trial tests a new treatment called D-PLEX, a type of antibiotic therapy, to determine if it can prevent infections after abdominal surgery. Participants will receive either D-PLEX with the usual care or just the usual care to compare outcomes. The goal is to assess whether D-PLEX is safe and effective in reducing infection risks. Individuals who have had planned colorectal surgery with a large abdominal incision and are stable before surgery might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

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.

Research shows that D-PLEX is generally safe for patients. Specifically, it has proven safe for immediate use in surgeries involving contaminated bones, helping to reduce infection risks without major complications. While detailed information about side effects in abdominal surgeries is lacking, its use in other surgeries suggests a favorable safety profile. As this trial is in a late stage, D-PLEX likely demonstrated a good safety record in earlier studies, increasing the likelihood of safety for participants.¹²³⁴⁵

D-PLEX is unique because it acts as an adjunct to the standard prophylactic antibiotic treatments, specifically targeting the prevention of surgical site infections. Unlike traditional antibiotics that circulate throughout the body, D-PLEX is applied directly at the surgical site, allowing for a sustained release of the antibiotic locally. This direct delivery method can potentially reduce the risk of systemic side effects and improve the effectiveness of infection prevention right where it's needed most. Researchers are excited about D-PLEX because it could represent a significant advance in reducing post-surgical infections with a more focused approach.

Research has shown that D-PLEX, which participants in this trial may receive, can greatly reduce infections at the surgery site after abdominal surgery. In one study, using D-PLEX with standard care led to 58% fewer infections compared to standard care alone. Specifically, fewer patients developed infections when D-PLEX was part of their treatment. The treatment delivers antibiotics directly to the surgery area, preventing bacteria from causing infections. Early results are promising, suggesting that D-PLEX could enhance current methods for preventing infections.¹²³⁶⁷