deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT02255487

Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen

Sponsor: Irrimax Corporation

Updated 10 times since 2017 Last updated: Apr 29, 2022 Started: Feb 18, 2015 Primary completion: Mar 13, 2017 Completion: Mar 13, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.

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This NA trial investigates Surgical Site Infection and is currently terminated or withdrawn. Irrimax Corporation leads this study, which shows 10 recorded versions since 2015 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotRecruiting~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshotSuspended~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotCompleted~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

10 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated NA

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated NA

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated NA

  4. Jun 2022 — Jul 2024 [monthly]

    Terminated NA

    Status: CompletedTerminated · Phase: PHASE4NA

  5. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE4

Show 5 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  2. Aug 2017 — Jun 2018 [monthly]

    Completed PHASE4

    Status: SuspendedCompleted

  3. Jul 2017 — Aug 2017 [monthly]

    Suspended PHASE4

    Status: RecruitingSuspended

  4. Feb 2017 — Jul 2017 [monthly]

    Recruiting PHASE4

  5. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE4

    First recorded

Feb 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Irrimax Corporation
Data source: Irrimax Corporation

For direct contact, visit the study record on ClinicalTrials.gov .