Dahua Hospital, Xuhui District, Shanghai
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Complete Wound Healing
研究概览
简要总结
These findings support the integrated use of ultrasonic debridement and photon therapy as a beneficial treatment strategy for advanced pressure injuries in elderly patients, demonstrating its value in improving both clinical results and overall patient well-being.
详细描述
This study assessed the clinical effectiveness of combining ultrasonic debridement with photon therapy for treating stage 3 and 4 pressure injuries in elderly patients, with particular attention to wound healing, pain reduction, and quality of life outcomes. We enrolled 118 elderly patients with pressure injuries from Shanghai Dahua Hospital between May 1, 2023, and November 30, 2024, using stratified random sampling. Participants were first grouped by injury stage (3 or 4) and then randomly assigned to either control or experimental groups. Control patients received standard moist wound care alongside systemic interventions, whereas the experimental group received the same standard care plus combined ultrasonic debridement and photon therapy. We compared outcomes including wound healing progress, treatment expenses, and pain scores recorded during dressing changes.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 55 years or older
- •a patient who is fully conscious (i.e., no disturbance of consciousness such as drowsiness, lethargy, or delirium; able to accurately answer questions about time, place, and person orientation; and capable of clear communication to express needs or understand study-related instructions)
- •patients with pressure injury were diagnosed with stage 3 or 4 pressure injury in accordance with the staging criteria of pressure injury published by the National Pressure Injury Advisory Panel (NPUAP).
排除标准
- •poor blood glucose control (HbA1c > 7.0%)
- •patients allergic to red-and-blue light
- •mental abnormalities who cannot cooperate with treatment
- •patients with advanced malignancies, terminal patients, patients with cachexia, and patients with severe obesity
- •severe complications: severe malnutrition, severe diseases of the lungs, liver, kidneys, and cardiovascular system
- •patients undergoing other treatments, such as Chinese medicine treatment, negative pressure aspiration therapy, platelet-rich therapy
- •who were unwilling to participate in the study. All participants signed a written informed consent form before the study began.
研究组 & 干预措施
Photon Therapy Combined with Ultrasonic Debridement Group
Participants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries.
干预措施: Photon Therapy Combined with Ultrasonic Debridement Group (Other)
Standard Wound Care Grou
Participants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention.
干预措施: Standard Wound Care Group (Other)
结局指标
主要结局
Proportion of Participants with Complete Wound Healing
时间窗: Assessed at 6 months post-randomization.
The primary outcome is the proportion of participants achieving complete wound healing, defined as a Pressure Ulcer Scale for Healing (PUSH) score of 0. The PUSH tool assesses wound area, exudate amount, and tissue type, with a total score range of 0-17.
次要结局
- Change in Pain Intensity During Dressing Changes(Baseline and 1 month post-intervention.)
- Total Direct Medical Cost of Treatment(From randomization to 6 months post-intervention.)
- Change in Wound Severity as Measured by the Pressure Ulcer Scale for Healing (PUSH) Score(Baseline, 1 month, 3 months, and 6 months post-intervention.)
研究者
Jie Zeng
Dahua Hospital, Xuhui District, Shanghai
Dahua Hospital, Xuhui District, Shanghai