At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Decreasing Intraoperative Skin Damage in Prone Position Surgeries
In Brief
A Phase 4 clinical trial evaluating Mepilex Border Flex® (MBF) dressing for Pressure Injury. Completed, enrolled 107 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.