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Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings (PUP16_01)

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ClinicalTrials.gov Identifier: NCT02962882
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Tracking Information
First Submitted Date  ICMJE August 23, 2016
First Posted Date  ICMJE November 15, 2016
Results First Submitted Date  ICMJE January 16, 2018
Results First Posted Date  ICMJE March 26, 2018
Last Update Posted Date March 26, 2018
Actual Study Start Date  ICMJE September 9, 2016
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication [ Time Frame: 4-6 days ]
    User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
  • User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication [ Time Frame: 4-6 days ]
    User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication [ Time Frame: 4-6 days ]
User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection of skin Ease of reapplication following skin inspection Conformability to contours of the body Overall impression of dressing
Change History Complete list of historical versions of study NCT02962882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
Wear Time (Days) for First Dressing [ Time Frame: 4-6 days ]
Maximum length of wear time/stay on ability of dressings in ICU.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
Wear Time in ICU [ Time Frame: 4-6 days ]
Maximum length of wear time/stay on ability of dressings in ICU.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 9, 2016)
Incidence of AE/ADE/SAE/SADE/DD [ Time Frame: 1-6 days ]
AE=Adverse Event, SAE= Serious Adverse Event, SADE= Serious Adverse Device Event, DD= Device Defficiency
 
Descriptive Information
Brief Title  ICMJE Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings
Official Title  ICMJE A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Brief Summary A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Detailed Description This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pressure Incidence Prevention
Intervention  ICMJE Device: Mepilex Border
Multi-layer Foam Dressings
Study Arms  ICMJE
  • Experimental: A. Mepilex Border Sacrum (Safetac)
    A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI).
    Intervention: Device: Mepilex Border
  • Experimental: B. Mepilex Border Heel (Safetac)
    A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI).
    Intervention: Device: Mepilex Border
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 4, 2017
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is at risk for developing a pressure injury to the heels and/or sacrum
  • Aged ≥ 18 years
  • Patient or his/her legal representative is able to understand and voluntarily sign the informed consent
  • Estimated treatment period in ICU for patient at least 4-6 days

Exclusion Criteria:

  • Patient has a pressure injury or blistering on sacrum and/or heels
  • Patient with known or suspected sensitivity to any of the components of the products being evaluated
  • Patient included in other clinical investigations at present or within the last 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962882
Other Study ID Numbers  ICMJE PUP16_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Molnlycke Health Care AB
Study Sponsor  ICMJE Molnlycke Health Care AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelli Potter, BSN, RN AnMed Health Medical Center
PRS Account Molnlycke Health Care AB
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP