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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

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

Condition or disease Intervention/treatment Phase
Pressure Incidence Prevention Device: Mepilex Border Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : May 4, 2017

Arm Intervention/treatment
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).
Device: Mepilex Border
Multi-layer Foam Dressings

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).
Device: Mepilex Border
Multi-layer Foam Dressings




Primary Outcome Measures :
  1. 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).


  2. 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).



Secondary Outcome Measures :
  1. Wear Time (Days) for First Dressing [ Time Frame: 4-6 days ]
    Maximum length of wear time/stay on ability of dressings in ICU.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962882


Locations
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United States, South Carolina
Anmed Health
Anderson, South Carolina, United States, 29621
Roper Hospital
Charleston, South Carolina, United States, 29401
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
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Principal Investigator: Kelli Potter, BSN, RN AnMed Health Medical Center

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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT02962882     History of Changes
Other Study ID Numbers: PUP16_01
First Posted: November 15, 2016    Key Record Dates
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Crush Injuries
Wounds and Injuries