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# FDA Agrees to PolyPid Phase 3 Study Design
- URL: https://www.fdaweb.com/fda-agrees-to-polypid-phase-3-study-design/
- Published: 2023-05-22T12:00:00.000Z
- Updated: 2026-09-14T18:33:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154501

FDA has agreed to a PolyPid Ltd. Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical site infections (SSIs). The revised trial will recruit patients undergoing colorectal resection surgery with large incisions (greater than 20 cm), according to the company. Recruitment into the trial will resume shortly, it says, with an enrollment goal of 550 additional patients beyond the 40 patients already recruited. Total recruitment time is expected to be 12 months and top-line results are due in mid-2024\. PolyPid says it will also conduct an unblinded interim analysis once 400 patients complete their 30-day follow-up.

PolyPid says SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is designed to assess the efficacy and safety of D-PLEX 100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in preventing post abdominal-surgery incisional infections. “The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery,” it says. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the U.S., Europe and Israel.