Trial · NCT03442777
Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
NCT03442777, Not applicable, Completed, Belgium Health Care Knowledge Centre; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer. Trials, record NCT03442777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03442777
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
- NCT number
- NCT03442777
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,634 participants, actual
- Lead sponsor
- Belgium Health Care Knowledge Centre
- Conditions
- Pressure Ulcer
- Interventions
- Allevyn® brand silicone adhesive multilayer foam dressings, Mepilex® brand silicone adhesive multilayer foam dressings
- First posted
- 2018-02-22
- Last updated
- 2021-04-26
- Results first posted
- 2021-04-26
- Limitations and caveats
Performance and detection bias may have occurred because patients, caregivers and study personnel could not be blinded to the study procedures/devices. All study nurses were trained, and for most hospitals wound care teams were involved when a PU occurred, further strengthening the correct identification of skin injuries.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | assessment during 14 days | 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/ |
| Other | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | maximum treatment or study period 14 days | The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum as judged onsite, during the study period (maximum 14 days). |
| Other | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | maximum treatment or study period 14 days | 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). |
| Other | The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | maximum treatment or study period 14 days | The number of patients who developed at least one new pressure ulcer of category 2 or worse on any greater trochanter as judged onsite, during the study period (maximum 14 days). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | assessment during 14 days | Intention to treat population (n=1605) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | maximum treatment or study period 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | maximum treatment or study period 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | maximum treatment or study period 14 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | 43 | Participants | ||
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | Control Group | 34 | Participants | ||
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | 30 | Participants | ||
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | Control Group | 26 | Participants | ||
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | 15 | Participants | ||
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | Control Group | 10 | Participants | ||
| The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | 1 | Participants | ||
| The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | Control Group | 0 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Group 1 (on Top of Standard of Care) | 542 | |
| Overall Study | STARTED | Intervention Group 2 (on Top of Standard of Care) | 545 | |
| Overall Study | STARTED | Control Group (Standard of Care) | 546 | |
| Overall Study | COMPLETED | Intervention Group 1 (on Top of Standard of Care) | 534 | |
| Overall Study | COMPLETED | Intervention Group 2 (on Top of Standard of Care) | 532 | |
| Overall Study | COMPLETED | Control Group (Standard of Care) | 539 | |
| Overall Study | NOT COMPLETED | Intervention Group 1 (on Top of Standard of Care) | 8 | |
| Overall Study | NOT COMPLETED | Intervention Group 2 (on Top of Standard of Care) | 13 | |
| Overall Study | NOT COMPLETED | Control Group (Standard of Care) | 7 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pressure ulcer development | Skin and subcutaneous tissue disorders | Intervention Group 1 (on Top of Standard of Care) | 1 | 539 | 1 |
| other | Pressure ulcer development | Skin and subcutaneous tissue disorders | Intervention Group 2 (on Top of Standard of Care) | 2 | 538 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | Intervention Group 1 (on Top of Standard of Care) | 4 | 539 | 4 |
| other | Erythema | Skin and subcutaneous tissue disorders | Intervention Group 2 (on Top of Standard of Care) | 4 | 538 | 4 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Intervention Group 1 (on Top of Standard of Care) | 3 | 539 | 3 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Intervention Group 2 (on Top of Standard of Care) | 1 | 538 | 1 |
| other | Blister formation | Skin and subcutaneous tissue disorders | Intervention Group 1 (on Top of Standard of Care) | 2 | 539 | 2 |
| other | Blister formation | Skin and subcutaneous tissue disorders | Intervention Group 2 (on Top of Standard of Care) | 1 | 538 | 1 |
| other | Exacerbates athlete's foot | Infections and infestations | Intervention Group 1 (on Top of Standard of Care) | 0 | 539 | 0 |
| other | Exacerbates athlete's foot | Infections and infestations | Intervention Group 2 (on Top of Standard of Care) | 1 | 538 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Group 1 (on Top of Standard of Care) | 27 | 539 |
| Total, all-cause mortality | Intervention Group 2 (on Top of Standard of Care) | 23 | 538 |
| Total, other adverse events | Intervention Group 1 (on Top of Standard of Care) | 16 | 539 |
| Total, other adverse events | Intervention Group 2 (on Top of Standard of Care) | 12 | 538 |
| Total, serious adverse events | Intervention Group 1 (on Top of Standard of Care) | 0 | 539 |
| Total, serious adverse events | Intervention Group 2 (on Top of Standard of Care) | 0 | 538 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33216969 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) vs Control Group: The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | Trial comparisons |
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 |
| 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 | Trial comparisons |
| Intervention Group 1 (on Top of Standard of Care) vs Intervention Group 2 (on Top of Standard of Care): deaths from any cause | Trial comparisons |
| Intervention Group 1 (on Top of Standard of Care) vs Intervention Group 2 (on Top of Standard of Care): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03442777
GET https://conductscience.org/api/trials/v1/NCT03442777/registered