Comparison · NCT03111875-d3152b01
Routine Thermal Management vs Aggressive Thermal Management: Deep or Organ-space Surgical Site 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. Routine Thermal Management vs Aggressive Thermal Management: Deep or Organ-space Surgical Site Infection. Trial comparisons, record NCT03111875-d3152b01. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03111875-d3152b01
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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 | 0.0633 | 0.0544 | 0.0736 | wilson | |
| Risk in group 2 | 0.0716 | 0.0621 | 0.0824 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00824 | -0.0223 | 0.00575 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.885 | 0.719 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.877 | 0.702 | 1.1 | log | |
| Number needed to treat, for one fewer participant with the outcome on Routine Thermal Management than on Aggressive Thermal Management | 121 | 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 | Routine Thermal Management | Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An Multi-Position Upper Body Warming Blanket forced-air cover will be positioned over an appropriate non-operative site, but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further.~routine thermal management: A forced-air cover will be positioned but will not initially be activated. The warmer will be activated when core temperature decrease to 35.5°C. | 157 | 2,479 | OG000 |
| Group 2 | Aggressive Thermal Management | Patients assigned to aggressive warming will be pre-warmed with a full-body Bair Hugger or Bair Paws cover for ≈30 minutes before induction of anesthesia. The warmer will initially be set to high which corresponds to ≈43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C, using an Multi-Position Upper Body and Full Access Underbody Warming Blankets forced-air covers when clinically practical. All intravenous fluids will be warmed to body temperature.~aggressive warming: Patients will be pre-warming 30 minutes before induction of anesthesia and aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C. | 178 | 2,487 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Deep or Organ-space Surgical Site Infection
- Description
Surgical site infection is defined by US Centers for Disease Control and Prevention criteria. It is consisted of superficial infection, deep infection, and organ-space infection.~Superficial infection: Infection involves only skin or subcutaneous tissue of the incision.~Deep infection: Infection appears to be related to the operation and infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision.~Organ-space infection: Infection involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was opened or manipulated during an operation.
- Time frame
- From the end of surgery to 30 days after surgery
- Population
- 20 patients were missing on this outcome in aggressive thermal management group and 27 patients were missing in routine thermal management group
Source ClinicalTrials.gov
Trial
- Title
- Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
- NCT number
- NCT03111875
- Phases
- NA
- Conditions
- Perioperative Care, Surgery--Complications, Hypothermia; Anesthesia, Myocardial Injury
- Interventions
- aggressive warming, routine thermal management
- Lead sponsor
- The Cleveland Clinic
- Results first posted
- 2023-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03111875?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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