Comparison · NCT03385304-d2237a6b
10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: Number of Participants With a Deep Incisional or Organ/Space Infection
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 10% Povidone-iodine (1% Free Iodine) in Purified Water vs 4% Chlorhexidine Gluconate (CHG) in Purified Water: Number of Participants With a Deep Incisional or Organ/Space Infection. Trial comparisons, record NCT03385304-d2237a6b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03385304-d2237a6b
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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 | 0.0584 | 0.0441 | 0.0771 | wilson | |
| Risk in group 2 | 0.0651 | 0.0498 | 0.0845 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0066 | -0.0308 | 0.0175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.899 | 0.611 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.892 | 0.591 | 1.35 | log | |
| Number needed to treat, for one fewer participant with the outcome on 10% Povidone-iodine (1% Free Iodine) in Purified Water than on 4% Chlorhexidine Gluconate (CHG) in Purified Water | 151 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).~10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.~4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. | 46 | 787 | OG000 |
| Group 2 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).~10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.~4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. | 51 | 784 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Deep Incisional or Organ/Space Infection
- Description
Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017):~Deep Incisional Infection:~Occurs within 90 days post definitive fracture management; \& involves fascial/muscle layers; \& has at least one of the following:~1. deep incision purulent drainage~2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \& has at least one of the following: fever (\> 38 °C); localized pain or tenderness~3. other evidence of deep incision infection on anatomical exam or imaging test~Organ/Space Infection:~Occurs within 90 days post definitive fracture management; \& involves any part of the body deeper than the fascial/muscle layers; \& has at least one of the following:~1. organ/space purulent drainage~2. organisms in organ/space identified by microbiologic testing~3. other evidence of organ/space infection on anatomical exam or imaging test
- Time frame
- Within 90 days of the patient's last planned fracture management surgery
- Population
Source ClinicalTrials.gov
Trial
- Title
- Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
- NCT number
- NCT03385304
- Phases
- PHASE4
- Conditions
- Surgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture
- Interventions
- 10% povidone-iodine (1% free iodine) in purified water, 4% chlorhexidine gluconate (CHG) in purified water
- Lead sponsor
- University of Maryland, Baltimore
- Results first posted
- 2023-03-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03385304?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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