Comparison · NCT00600483-sae
Gentamicin Group vs Control Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Gentamicin Group vs Control Group: serious adverse events. Trial comparisons, record NCT00600483-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00600483-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.362 | 0.328 | 0.397 | wilson | |
| Risk in group 2 | 0.382 | 0.348 | 0.417 | wilson | |
| Risk difference, group 1 minus group 2 | -0.02 | -0.0687 | 0.0288 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.948 | 0.831 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.918 | 0.744 | 1.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Gentamicin Group than on Control Group | 49.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Gentamicin Group | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy~gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | 269 | 743 | EG000 |
| Group 2 | Control Group | Standard of care, ie, insertion of no gentamicin-collagen sponge. Includes patients randomized to Gentamicin but where not treated in the Gentamicin group | 290 | 759 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 90 days from Randomization.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
- NCT number
- NCT00600483
- Phases
- PHASE3
- Conditions
- Cardiac Surgery, Sternal Wound Infection
- Interventions
- gentamicin-collagen sponge dipped in saline
- Lead sponsor
- Innocoll
- Results first posted
- 2022-05-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00600483?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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