Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- scar thickness (cm)
研究概览
简要总结
The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns.
详细描述
The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns. Nonablative laser treatment was performed on 30 patients with hypertrophic scars on both sides of the same part of the body. Immediately after the laser treatment, the hypertrophic scars of right side to which HSCM was applied and the left side with the same body position were defined as a control scar, and normal saline was applied. Over the next 6 days, HSCM and moisturizer were applied on the scars of right side, and only moisturizer was applied on the control scar of left side. Laser treatment was performed three times on the hypertrophic scar at 4 weeks intervals. The skin test on hypertrophic scar was evaluated before laser treatment and re-evaluated on the 7the day after the 3rd laser treatment. 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. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in μg/cm2. 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 (Table 1). 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. To evaluate the effect of HSCM, investigators compared the skin test results (thickness, melanin, erythema, TEWL, sebum, and skin elasticity levels) between the right side and control side, from baseline measures immediately before the laser treatment and measures on the 7the day after the 3rd laser treatment. 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, skin abrasion, and swelling) were observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
After laser treatment on hypertrophic scars, human stem cell media was applied to one side and physiological saline was applied to the other side.
入排标准
- 年龄范围
- 19 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •partial or full-thickness burns that healed spontaneously or required skin grafting
- •with hypertrophic scars on the right and left sides of the same body part
排除标准
- •Patients with open wounds or infection on the burn scars
- •those taking steroids for the scars
- •with allergies to topical anesthetic cream
- •those who were pregnant
- •undergoing any other medical treatment or condition affecting wound healing (e.g., diabetes)
结局指标
主要结局
scar thickness (cm)
时间窗: baseline
The thickness was measured with a ultrasonic wave equipment
change from baseline scar thickness at 3 months (cm)
时间窗: after 3 months intervention
the change of scar thickness was measured with a ultrasonic wave equipment
次要结局
- melanin levels (arbitraty units; AU)(baseline)
- change from baseline melanin level at 3 months (arbitraty units; AU)(after 3 months intervention)
- erythema level (arbitraty units; AU)(baseline)
- change from baseline erythema level at 3 months (arbitraty units; AU)(after 3 months intervention)
- transepidermal water loss (g/h/m2)(baseline)
- change from baseline transepidermal water loss at 3 months (g/h/m2)(after 3 months intervention)
- Sebum level (μg sebum/cm2)(baseline)
- change from baseline sebum level at 3 months (μg sebum/cm2)(after 3 months intervention)
