Autopsy report · NCT02255487

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

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

The sponsor’s own words in the registry.

Life of this trial

• Registered 5 months before it started.
• Ran for about 2 years 1 month before it stopped.
• 627 participants enrolled.
• Results were posted on the registry 5 years 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Irrimax Corporation

Sponsor type

Industry

Conditions

Surgical Site Infection

Interventions

IrriSept System; No Intervention - Standard of Care (SoC) only

Participants

627

Sites

17

Countries

United States

Trials that died the same way

• Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
  “The study was terminated after interim data analysis” (85% match in meaning)
• Adherence to Antidepressant Treatment in Subjects With Depression
  “The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.” (82% match in meaning)
• A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
  “This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.” (80% match in meaning)
• Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
  “Study terminated as a result of interim analysis not meeting predetermined criteria.” (80% match in meaning)
• A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
  “Study was stopped following interim analysis.” (79% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.