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Completed

NCT Number: NCT02295735

Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention

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

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Mepilex® Border Sacrum and Mepilex® Border Heel

Device

Primary outcomes

  1. Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)

Secondary outcomes

  1. 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)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)

  2. Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)

  3. 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)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)

  4. Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    Number of preventive sacrum dressings used for pressure ulcer prevention

  5. Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    Support surface categories were recorded. Please see the different types in the Outcome measure data table

  6. Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    • Time to Pressure ulcer development in days

  7. Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    Number of preventive heel dressings used for pressure ulcer prevention

  8. Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    • Time to Pressure ulcer development in days

  9. 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)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days

  10. 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)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days

  11. Follow up Period of Included ICU Patients (Days)

    Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

    Follow up period of included ICU patients in mean (days)

Sponsors and collaborators

Lead sponsor

PD Dr. Jan Kottner

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2014
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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