N/A
Completed N=475
Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention
Source: ClinicalTrials.gov NCT02295735 ↗Enrolled (actual)
475
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) — 6; 22 Pressure ulcer
Summary
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) |
6; 22 | — |
| SECONDARY Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) |
7.8; 30.5 | — |
| SECONDARY Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) |
6; 28 | — |
| SECONDARY Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) |
8.0; 37.6 | — |
| SECONDARY Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention |
1050; 0 | — |
| SECONDARY Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) |
212; 209; 149; 117; 79; 85 | — |
| SECONDARY Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum |
10.8; 13.5 | — |
| SECONDARY Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention |
2260; 0 | — |
| SECONDARY Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum |
10.8; 13.2 | — |
| SECONDARY Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) |
60.7; 89.0 | — |
| SECONDARY Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) |
60.7; 54.6 | — |
| SECONDARY Follow up Period of Included ICU Patients (Days) |
11.0; 14.3 | — |
Eligibility Criteria
- Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
- Being at "high" or "very high" PU risk according to the Charité PU prevention standard:
- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
- Expected minimum length of stay at least three days
- Informed consent (or by legal representative)
Data sourced from ClinicalTrials.gov (NCT02295735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.