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Completed Phase 3 Interventional Results available

D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

ClinicalTrials.gov ID: NCT04233424

Public ClinicalTrials.gov record NCT04233424. 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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:46 PM EDT

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 311- 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 I)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04233424
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
PolyPid Ltd.
Industry
Enrollment
977 participants

Conditions and interventions

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
Jun 24, 2020 (Actual)
Primary completion
Sep 2, 2022 (Actual)
Completion
Sep 2, 2022 (Actual)
Last update posted
Apr 21, 2026

2020 – 2022

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Shoals Medical Trials Sheffield Alabama 35660 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Paradigm Clinical Research Center Redding California 96001 —
Tufts Medical Center Boston Massachusetts 02111 —
Summit Medical Group Bend Oregon 97701 —

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 57 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04233424, 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 Apr 21, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04233424 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →