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

NCT02295735 | Completed Results

• 1 other identifier: CRC-PU-A-16
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcer

Keywords

Skin, safety, wounds, intensive care

Outcome Measures

Primary Outcomes (1)

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

  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)

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

Secondary Outcomes (11)

• 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)

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

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

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

• 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)

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

• Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention

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

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

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

Study Arms (2)

Mepilex® Border

EXPERIMENTAL

If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention

Device: Mepilex® Border Sacrum and Mepilex® Border Heel

Control

NO INTERVENTION

Standard pressure ulcer prevention according to hospital standard

Interventions

Mepilex® Border Sacrum and Mepilex® Border Heel DEVICE

Mepilex® Border

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• PD Dr. Jan Kottner: lead

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: PD Dr. Jan Kottner
• Organization: Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy

jan.kottner@charite.de

+4930450518218

Study Officials

• Jan Kottner, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. rer cur

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 20, 2014
• Study Start: June 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Locations

DE (1)