Phase 4
N=107
Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Pressure Injury
Bottom Line
View on ClinicalTrials.gov: NCT04884737 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI) — 13; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mepilex Border Flex® (MBF) dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI) |
13; 14 | — |
| PRIMARY Number of Participant With Erythema, Abrasions, and Moisture Associated Skin Damage (MASD) |
0; 0 | — |
| PRIMARY Number of Participants With a (Sub-epidermal Moisture) SEM Scanner Difference of Greater Than 0.5pF Measured at Preoperative Day of Surgery and at Least One Postoperative Assessment |
17; 11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A participant must 18 years or older and is scheduled for surgery in the prone position to be conducted at UCLA Santa Monica Medical Center.
Exclusion Criteria
- Patients who are not scheduled for surgery in the prone position. Patients with known allergy to the components of the Mepilex Border Flex (MBF) dressing which consists of silicone, polyurethane, polyacrylate, viscose, polyester and polyolefin.
Data sourced from ClinicalTrials.gov (NCT04884737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.