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NCT04884737 · ClinicalTrials.gov registry record · Phase 4
Decreasing Intraoperative Skin Damage in Prone Position Surgeries
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 107
- Enrollment target
NCT04884737: Completed Phase 4 study, sponsored by University of California, Los Angeles.
NCT04884737 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 107 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04884737, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 107 participants
- Enrollment target
Study Summary
Preventing Pressure Injuries among patients undergoing spinal or orthopedic surgery in the prone position is challenging because of position required for surgical access and limited availability of pressure reduction surfaces for prone position operating tables. A new dressing technology (Mepilex Border Flex® (MBF) provides increased conformability of the dressing to the skin with the ability of the dressing to move in all directions (e.g., 360-degree flexibility) with even slight body movements. Limited data exists on use of silicone foam dressings with all direction flexibility during prone surgical procedures. The investigators will partents scheduled for surgery in the prone position at UCLA Santa Monica Medical Center and propose to examine use of the MBF dressings on the chest, iliac crest, and face (chin, cheeks, forehead) of patients undergoing this type of surgery using a prospective, non-randomized pre/post intervention clinical trial design. Three outcome measures will be compared between patients undergoing prone surgery with standard care (no dressings, pressure reduction positioning on the operating table) and those with standard care and use of MBF dressings placed on the chest, iliac crest and face: (1) incidence of erythema and pressure injuries on face, chest and iliac crest determined by visual skin assessment between the two groups, (2) incidence of moisture associated skin damage (MASD) and friction abrasions on face, chest and iliac crest determined by visual skin assessment between the two groups, and (3) SEM measures indicative of pressure injury damage on face, chest, iliac crest between the two groups. The study will also include a 6-month retrospective medical record review of patients who underwent prone surgeries from February 1, 2018 through July 31, 2018 to determine a historical pressure injury facility incident rate. The year 2018 was chosen to avoid changes associated with the COVID-19 pandemic.
Primary Outcome
Pressure damage to skin and soft tissues based on visual skin assessment
Interventions
- OTHER Mepilex Border Flex® (MBF) dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 4 |
What the finished NCT04884737 record still lists
NCT04884737 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepilex Border Flex® (MBF) dressing is the first listed.
NCT04884737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04884737 about?
NCT04884737 is a clinical study titled "Decreasing Intraoperative Skin Damage in Prone Position Surgeries". Preventing Pressure Injuries among patients undergoing spinal or orthopedic surgery in the prone position is challenging because of position required for surgical access and limited availability of pressure reduction surfaces for prone position operating tables. A new dressing technology (Mepilex Bo...
What is the current status of trial NCT04884737?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 107 participants. The study started on 2021-07-02. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT04884737?
The interventions under investigation include: Mepilex Border Flex® (MBF) dressing (OTHER).
Who is sponsoring clinical trial NCT04884737?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04884737's enrollment target sits among peer trials
107 745th of 2000 higher than 1,254 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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