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Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Phase 4 trial testing Mepilex Border Flex® (MBF) dressing in Pressure Injury in 107 participants. Completed in 10 March 2023.
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 107 |
| Start date | 2 July 2021 |
| Primary completion | 13 May 2022 |
| Estimated completion | 10 March 2023 |
| Sites | 1 location across United States |
University of California, Los Angeles
18 and older, any sex, with Pressure Injury. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pressure damage to skin and soft tissues based on visual skin assessment
| Group | Value | 95% CI |
|---|---|---|
| Pre-Intervention | 13 | |
| Intervention | 14 |
redness and skin damage from moisture or friction
| Group | Value | 95% CI |
|---|---|---|
| Pre-Intervention | 0 | |
| Intervention | 0 |
Difference of greater than 0.5pF between pre-operative and first post-operative readings of SEM (sub epidermal moisture or edema) at any anatomic site (face sites, chest, iliac crest)
| Group | Value | 95% CI |
|---|---|---|
| Pre-Intervention | 17 | |
| Intervention | 11 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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