D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Public ClinicalTrials.gov record NCT04411199. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
D-PLEX 312 - Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Study identification
- NCT ID
- NCT04411199
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- PolyPid Ltd.
- Industry
- Enrollment
- 800 participants
Conditions and interventions
Interventions
- D-PLEX Drug
- Standard of Care (SoC) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2020
- Primary completion
- Apr 13, 2025
- Completion
- May 9, 2025
- Last update posted
- Jun 9, 2025
2020 – 2025
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Augusta Univeristy | Augusta | Georgia | 30912 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Penn State Health Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04411199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04411199 live on ClinicalTrials.gov.