Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (59 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-10-31, after 2011-10-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-10-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chemotherapydlsurgery000systemic
Phrases that lowered it: singleopenkgmildbmi -
Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 20 (lowers risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 14.4% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 93.2% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: 85 (lowers risk) · Who can join
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1465 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 313 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- chlorhexidine gluconate, povidone iodine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Perioperative Patient Skin Antiseptic Preparation Evaluation NCT04756804 · started 2021 · scored riskier than 15% of active trials completed
- Reduction of Postoperative Wound Infections by Antiseptica? NCT04055233 · started 2015 · scored riskier than 27% of active trials completed
- Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures NCT04048356 · started 2019 · scored riskier than 39% of active trials completed
- Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery NCT02618720 · started 2016 · scored riskier than 53% of active trials completed
- Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in Laparoscopy NCT02591251 · started 2015 · scored riskier than 8% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.