Comparison · NCT03442777-423434ca
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 Sacrum, Heels or Greater Trochanter
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 Sacrum, Heels or Greater Trochanter. Trial comparisons, record NCT03442777-423434ca. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03442777-423434ca
On this page
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 | 0.0403 | 0.0301 | 0.0539 | wilson | |
| Risk in group 2 | 0.0631 | 0.0455 | 0.0869 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0227 | -0.0486 | -0.000534 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.639 | 0.413 | 0.991 | log | |
| Odds ratio, group 1 over group 2 | 0.624 | 0.393 | 0.991 | 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 | 44 | 20.6 | 1,870 | from the risk difference interval |
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 | 43 | 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 | 34 | 539 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter
- Description
The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum, heels or greater trochanter as judged onsite, during the study period (maximum 14 days).~Patients in experimental groups 1 and 2 were pooled as the treatment group and compared to the control group (in the intention to treat population (n=1605)~Note: The International NPUAP/EPUAP Pressure Ulcer Classification System (National Pressure Ulcer Advisory Panel (2014)) distinguishes four categories of pressure ulcers: non-blanchable erythema of the intact skin (category I), partial thickness loss of dermis (category II), full thickness tissue loss (category III) and full thickness tissue loss with exposed bone, tendon or muscle (category IV). Also unstageable pressure ulcers and deep tissue injuries can be recognised. https://npiap.com/
- Time frame
- assessment during 14 days
- Population
- Intention to treat population (n=1605)
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03442777-423434ca