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临床试验/NCT04456543
NCT04456543Unknown不适用

Comparison and Clinical Utility of the Portable Pressure Measuring Device for Garment Pressure Measurement on Hypertrophic Scar by Burn Injury During Compression Therapy

Hangang Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
48
试验地点
1
主要终点
Change from baseline scar thickness at 8 weeks

研究概览

简要总结

The investigators developed a portable pressure measuring device using silicon piezoresistive pressure sensors. As PicoPress® is the most accurate (i.e., lowest variation and error) manometric sensor for pressure measurement, the investigators used it to compare and examine the accuracy of the proposed device regarding in vitro pressure measurements. The purpose of this study was to determine the effectiveness of pressure garment therapy using proposed device with objective data obtained with a randomized within wound comparison. Pressure measurements were acquired through a readout circuit consisting of an analog-to-digital converter, a microprocessor, and a Bluetooth transmission module for wireless data transmission to an external device. The mean pressure values measured by the sensors were compared to those obtained from PicoPress®. This was a double-blinded, randomized, controlled trial of patients with hypertrophic scars. In the pressure monitoring group, garment pressures were monitored using the portable pressure measuring device, and the compression garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25 mmHg. In the control group, non-surgical standard treatment of burn scars except for pressure monitoring was performed in the same manner.

详细描述

The investigators developed a portable pressure measuring device using silicon piezoresistive pressure sensors. As PicoPress® is the most accurate (i.e., lowest variation and error) manometric sensor for pressure measurement, the investigators used it to compare and examine the accuracy of the proposed device regarding in vitro pressure measurements. The purpose of this study was to determine the effectiveness of pressure garment therapy using proposed device with objective data obtained with a randomized within wound comparison. Pressure measurements were acquired through a readout circuit consisting of an analog-to-digital converter, a microprocessor, and a Bluetooth transmission module for wireless data transmission to an external device. The mean pressure values measured by the sensors were compared to those obtained from PicoPress®. This was a double-blinded, randomized, controlled trial of patients with hypertrophic scars. In the pressure monitoring group, garment pressures were monitored using the portable pressure measuring device, and the compression garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25 mmHg. In the control group, non-surgical standard treatment of burn scars except for pressure monitoring was performed in the same manner. To evaluate the effect of a pressure monitoring device, the investigators compared the skin test results (thickness, melanin, erythema, TEWL, and skin elasticity levels) between the two groups, from baseline measures immediately before the treatment and measures immediately after 2 months. The participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. Transepidermal water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. The parameters consist of the following biomechanical skin properties: distenstibility, elasticity, and viscoelasticity. Distensibility means the length of total displacement from initial postion at maximum negative pressure. Gross elasticity means the ability of the skin to return to its initial position following displacement. Biologic elasticity means the ratio of immediate retraction to total displacement. Viscoelasticity means the ratio of delayed distension of immediate distension. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. Possible complications (pain, ecchymosis, pain, skin abrasion, and swelling) were observed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants are randomly devided into two groups. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult over 18
  • •partial-/full-thickness burns
  • •fully epithelialization after spontaneously healed or required skin grafting

排除标准

  • •open wounds
  • •infection on the burn scars
  • •those taking steroids for the scars
  • •condition affecting wound healing (e.g., diabetes)

研究组 & 干预措施

Pressure monitoring group

Experimental

In the pressure monitoring group, garment pressures were monitored using the portable pressure measuring device and the compression garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25 mmHg for 2 months. Subjects were instructed to wear the garment 23 hours per day, removing them only for bathing.

干预措施: pressure monitoring (Procedure)

conventional treatment group

Active Comparator

In the conventional treatment group, non-surgical standard treatment of burn scars except for pressure monitoring was performed in the same manner. Subjects were instructed to wear the garment 23 hours per day, removing them only for bathing.

干预措施: pressure monitoring (Procedure)

结局指标

主要结局

Change from baseline scar thickness at 8 weeks

时间窗: 8 weeks (before intervention and 8 weeks after intervention)

hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.

次要结局

  • Change from baseline scar pigmentation at 8 weeks(8 weeks (before intervention and 8 weeks after intervention))
  • Change from baseline scar erythema at 8 weeks(8 weeks (before intervention and 8 weeks after intervention))
  • Change from baseline skin dryness at 8 weeks(8 weeks (before intervention and 8 weeks after intervention))
  • Change from baseline skin elasticity at 8 weeks(8 weeks (before intervention and 8 weeks after intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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