NCT04411199Phase 3Completed

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

Study sponsor: PolyPid Ltd. · PYPD

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-04-14Actual
Enrollment · participants975Actual
Source updated2026-07-13Last update listed in the registry record
Version history

Changes to this trial

Last 12 months
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· 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Infection Rate as Measured by the Proportion of Subjects With an Surgical Site Infection (SSI) Event in the Population of Subjects With Target Incision Length >20 cm

+ After

Measure: Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >20 cm

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· 2 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control. Measure: Safety of D-PLEX in Prevention of Post Abdominal Surgery Measure: Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional

+ After

Measure: Infection Rate as Measured by the Proportion of Subjects With an Surgical Site Infection (SSI) Event in the Population of Subjects With Target Incision Length >20 cm

Actual enrollment increased by 175 participants

− Before

800 participants (actual)

+ After

975 participants (actual)

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