Comparison · NCT03442777-0f14065e
Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) vs Control Group: Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel
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. Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) vs Control Group: Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel. Trial comparisons, record NCT03442777-0f14065e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03442777-0f14065e
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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 | 0.0141 | 0.00855 | 0.0231 | wilson | |
| Risk in group 2 | 0.0186 | 0.0101 | 0.0338 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00448 | -0.0207 | 0.00787 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.758 | 0.343 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 0.755 | 0.337 | 1.69 | log | |
| Number needed to treat, for one fewer participant with the outcome on Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) than on Control Group | 223 | 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 | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Participants in intervention groups 1 and 2~* were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay.~* received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care.~* Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention.~* The maximum treatment duration was 14 days | 15 | 1,066 | OG000 |
| Group 2 | Control Group | Participants in control group~* were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay.~* received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care.~* No silicone adhesive multilayer foam dressings were applied~* The maximum study duration was 14 days | 10 | 539 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel
- Description
- The number of participants who developed at least one new pressure ulcer of category 2 or worse on any heel as judged onsite, during the study period (maximum 14 days).
- Time frame
- maximum treatment or study period 14 days
- Population
Source ClinicalTrials.gov
Trial
- Title
- Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
- NCT number
- NCT03442777
- Phases
- NA
- Conditions
- Pressure Ulcer
- Interventions
- Allevyn® brand silicone adhesive multilayer foam dressings, Mepilex® brand silicone adhesive multilayer foam dressings
- Lead sponsor
- Belgium Health Care Knowledge Centre
- Results first posted
- 2021-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03442777?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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