Comparison · NCT03442777-sae
Intervention Group 1 (on Top of Standard of Care) vs Intervention Group 2 (on Top of Standard of Care): 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. Intervention Group 1 (on Top of Standard of Care) vs Intervention Group 2 (on Top of Standard of Care): serious adverse events. Trial comparisons, record NCT03442777-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03442777-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 | 0 | 0.00708 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00709 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00709 | 0.00708 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Intervention Group 1 (on Top of Standard of Care) | Allevyn® brand silicone adhesive multilayer foam dressings~* Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith \& Nephew (Allevyn® brand). | 0 | 539 | EG000 |
| Group 2 | Intervention Group 2 (on Top of Standard of Care) | Mepilex® brand silicone adhesive multilayer foam dressings~* Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). | 0 | 538 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
They will be recorded between the first usage of the study dressings and the last study related intervention for that patient for Adverse Device Events (ADEs) (usually maximum 14 days) and till 30 days after last study related intervention for SADEs/MDIs.
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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GET https://conductscience.org/api/comparisons/v1/NCT03442777-sae