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临床试验/NCT04884737
NCT04884737已完成4 期

Decreasing Intraoperative Skin Damage in Prone Position Surgeries

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2021年7月2日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
107
试验地点
2
主要终点
Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI)

研究概览

简要总结

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.

详细描述

Preventing pressure injuries (PrIs) from developing during surgery is difficult due to insensitivity and immobility of the patient and the positioning needed for safe surgical access. Intraoperative acquired pressure injury (IAPI) rates are reported from 4% to 45% (1). IAPI rates vary due to differences in defining PrIs, surgical positions and because tissue damage that occurs in surgery may not be visible on the skin surface initially with the resulting PrI presenting several days post operatively (2,3). The sustained pressure, deformation, and shear forces on the tissues combined with changes in blood flow due to blood loss, vasopressor and anesthesia use, and temperature changes present unique risk factors for PrI development during surgery (1). Reducing PrI damage during surgery requires preventive strategies to decrease the mechanical forces of pressure and shear on the tissues loaded in the unique positions required for surgical access. In the supine position for surgery, use of silicone foam dressings on the sacrum and heels with pressure reducing devices on the operating table have decreased IAPIs (4, 5).

The prone position for surgery has been shown to be a risk factor for IAPIs in multiple studies (1,2,4,14). Yet, there is limited data on IAPIs for surgeries in the prone position with Luo and colleagues reporting incidence at 4.7% and Yoshimura et al showing an 11% incidence (4,15). Preventing PrIs among patients undergoing spinal or orthopedic surgery in the prone position is especially challenging because of positioning required for surgical access and limited availability of pressure reduction surfaces for prone positioner operating tables (2,15). The face, chest, and iliac crest are all loaded on small operating table surfaces in the prone position. These anatomic locations have limited soft tissue for compression and small surface areas and because of this, distribution of pressure and shear forces over a large surface area is not possible. Thus, the intensity of the pressure and shear force over these anatomic areas is high. Shear force is particularly problematic as tissues change due to variations in blood volume and flow, anesthesia and vasopressor use, and initiation of the inflammatory response during the surgical procedure all of which may increase shear forces on the tissues (1,2,16). Use of silicone foam dressings on the iliac crest and chest has been shown to reduce IAPIs in the prone position for spinal surgery (15). Most recently, use of silicone foam dressings has been suggested for use to decrease PrIs in patients with acute respiratory distress syndrome (ARDS) from COVID-19 who are placed in prone position to manage respiratory distress (17,18). Issues with use of silicone foam dressings intraoperatively is keeping the dressing in place while positioning for surgery preoperatively, protecting the skin and allowing for movement and changes in the tissues intraoperatively, and safe nontraumatic removal immediately postoperatively. 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 while using a silicone-based adhesive allowing for atraumatic removal.

The investigators will examine use of MBF dressings on the chest, iliac crest, and face (chin, cheeks, forehead) of patients undergoing surgery in a prone position using a prospective, non-randomized pre/post-intervention clinical trial. The specific aims are to:

  1. Compare IAPI, erythema, and skin damage (e.g., friction abrasions, moisture associated skin damage (MASD)) incidence of patients undergoing surgery in a prone position with use of standard care to use of MBF dressings placed on chest, iliac crest, and face with standard care.
  2. Compare subepidermal moisture (SEM) values (a biophysical measure of inflammatory tissue changes) of patients undergoing surgery in a prone position with use of standard care to use of MBF dressings placed on chest, iliac crest, and face along with standard care.
  3. Explore cost estimates for use of MBF dressings placed on chest, iliac crest, and face for surgery in a prone position.

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 chest, iliac crest, and face: (1) incidence of erythema and PrIs on anatomic locations from visual skin assessment, (2) incidence of moisture associated skin damage (MASD) and friction abrasions on anatomic locations, and (3) SEM measures indicative of PrI damage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI)

时间窗: Within 5 days of surgery

Pressure damage to skin and soft tissues based on visual skin assessment

Number of Participant With Erythema, Abrasions, and Moisture Associated Skin Damage (MASD)

时间窗: Within 5 days of surgery

redness and skin damage from moisture or friction

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

时间窗: preoperatively and first postoperative assessment (within 24 hours)

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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Bates-Jensen, PhD, RN, FAAN

Professor

University of California, Los Angeles

研究点 (2)

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