Effect of Negative Pressure Therapy on Skin Blood Flow Responses in the Scar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Skin Blood Flow
研究概览
简要总结
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF. However, it is unclear what dosage of NPT is most effective in treating scars.
This study compared NPT dosages of -105 mmHg, -125 mmHg, and -145 mmHg to assess the impact of NPT treatment on SBF in scar tissue and the correlation of NPT. If participants experience any symptoms of discomfort, NPT can be discontinued immediately.
36 scarred subjects were recruited to assess the efficacy of various NPT interventions. SBF applications are defined as perfusion levels instantly affecting NPT, and termination is defined as SBF after NPT.
The study runs from May 11, 2022, to May 11, 2023, at Asia University Hospital.
This study was funded by the National Science and Technology Council, Taiwan (NSTC 112-2221-E-468-004)
The main contact was Chi-Wen Lung, the person in charge of a college or university department of Product Design, Asia University, Taichung 413305, Taiwan.Email address: cwlung@asia.edu.tw
详细描述
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF.
This study's hypothesis was that NPT can enhance SBF in scar tissue and that the specific NPT dose affects this effect. The purpose of this study was to confirm the different dosages of NPT applied to scar tissue by comparing the blood flow before and after the effects of different NPT dosages. This will also contribute to the emerging field of scar treatment and provide evidence-based recommendations.
All recruited participants were approached to participate in a research study investigating the effects of NPT in a double-blind, parallel-group study on scar healing. This study used three negative pressure changes at -105, -125 mmHg, and -145 mmHg at 10 min. The suction method created a negative pressure in the cup using an electronic negative-pressure device (Medi Pump TC-2000V; Anest Iwata Sparmax Co., Ltd., Taipei, Taiwan). A cup with an inner diameter of 45 mm and outer diameter of 53 mm was used for cupping therapy. Each side of the cup rim had a width of 4 mm; therefore, no pain was caused by the cup rim.
Pearson product-moment correlation analysis was used to determine the correlations between the SBF-Baseline, SBF-Application, and SBF-Termination factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Aged 18 years or older.
- •Wounds must have been present for at least 21 days.
- •The participants were in the proliferation or remodeling phase.
- •Within nine months of skin injury.
排除标准
- •Incomplete wound healing.
- •leakage of tissue fluid.
- •Participants of the Edema.
- •The other short-term treatment plans (pressure garments, radiotherapy, steroids, and cryotherapy).
结局指标
主要结局
Skin Blood Flow
时间窗: Three minutes before to three minutes after negative pressure treatment
The skin blood flow (SBF) before negative pressure therapy (NPT) recorded from 30 seconds to 1 minute was defined as the SBF-termination value. The 0-30 seconds SBF before NPT was the baseline SBF-Baseline. The records of the calculated NPT value from 10 minutes to 10.5 min are defined as application value. The record with 30 seconds to 1 minute after NPT is defined as the SBF-termination value. The evaluation standard is the 30-second average.
次要结局
未报告次要终点