Clinical trial NCT02295735: Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention
Official title: A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Skin, safety, wounds, intensive care
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

Detailed description: Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.

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)

Primary outcomes:
measure: Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Secondary outcomes:
measure: 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)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: 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)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: 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)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: 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)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
measure: Follow up Period of Included ICU Patients (Days)
timeFrame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan Kottner, PhD
role: PRINCIPAL_INVESTIGATOR
References: