Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- The total effectiveness rate
研究概览
简要总结
63 patients with chronic infectious wounds were enrolled in the controlled study. They were randomly divided into three groups equally. Group 1 (Grp.1): The patients received hydrogel dressing change at three days intervals. Group 2 (Grp.2): The patients received ALA-PDT treatment at ten days intervals for 4 sessions. Groups 3 (Grp.3): The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. The wound healing rate, total effective rate, patient satisfaction, adverse reaction, and recurrence were assessed in all groups.
详细描述
Randomly divide the enrolled patients into three groups for treatment by utilizing SAS software (SAS Institute, Cary, NC, U.S.A.). Initially, the wound pus and secretions were washed three times with a sterile saline solution. Subsequently, surgical instruments were employed to debride the wound, particularly the necrotic tissue, as well as any carrion and foreign bodies within the wound bed and cavity, with care being taken to avoid injury to nerves and blood vessels in the surrounding area. Grp.1 was covered with hydrogel dressing (PAUL HARTMANN AG, Germany) and replaced 2-3 times a week with topical mupirocin ointment three times a day. Grp.2 received photodynamic therapy only. Grp.3 accepted PDT, then coated with hydrogel dressing as mentioned above. The treatment protocol of PDT is described as follows: after thorough debridement, ALA (Shanghai Fudan-Zhang jiang Bio-Pharmaceutical Co. Ltd, China) in an oil-in-water emulsion was smeared on the wound. After covering with dark plastic film for 3h, the wounds were illuminated by a light-emitting diode (LED) red light (Shenzhen Lifotronic Technology Co., Ltd, China). After the operation, a cold ice compress can be used to relieve the swelling and pain. Then, the hydrogel was uniformly applied to the wound and its surroundings (Grp.3). Grp.2 and Grp.3 received PDT at an interval of ten days for 4 sessions. In all groups, treatment responses and adverse reactions were recorded. All patients received the treatment as mentioned above and then evaluated the clinical outcome. After the end of the treatment, all patients returned for follow up at weeks 2, 4, 8 and 12.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) patients with chronic wounds caused by trauma or surgery who failed to heal after traditional formal medical treatment at least over three months;
- •2) Patients with stable vital signs who had no systemic medical disease and did not take glucocorticoids, immunosuppressive agents, or anticoagulants during the entire treatment process;
- •3) Participants provided signed informed consent, were able to comply with the program, were willing to participate in follow-up, and were able to cooperate in the observation of adverse events and efficacy;
- •4) The diameter of the skin wound should not exceed 10 centimeters.
排除标准
- •1) Patients are allergic to ALA;
- •2) Women with recent fertility, pregnancy or lactation plans;
- •3) Patients with deepening wounds or worsening infections;
- •4) Poor compliance leading to an inability to complete the treatment in its entirety;
- •5) Cutaneous ulcer caused by vascular disease, autoimmune diseases, metabolic diseases, local or metastatic malignant tumors.
结局指标
主要结局
The total effectiveness rate
时间窗: Up to 12 weeks after the end of the treatment.
The evaluation criteria were as follows: 1) If the wound area is completely healed, treatment was considered "significantly effective" (SE); 2) if the wound area was at least 50% healed, treatment was considered "effective" (E); 3) If the wound area was healed 30 - 50%, the treatment is considered as "improved" (IMP); 4) If the wound area is healed less than 30%, it is considered as "ineffective" (INE). "The total effectiveness rate" (Et) was calculated from the equation as follows: Et = (NSE+NE)/Nt × 100% NSE = the number of patients belonging to the SE groups NE = the number of patients belonging to the E groups Nt = the total number of patients
Patient satisfaction
时间窗: Up to 12 weeks after the end of the treatment.
Patients were surveyed about their level of satisfaction with the results after 12 weeks following the final course of treatment with the results as "satisfied," "somewhat satisfied," "somewhat dissatisfied," or "dissatisfied."
Wound healing rate
时间窗: Up to 12 weeks after the end of the treatment.
Panoramic photographs of the wounds were taken by the same observer at each treatment and return visit using a digital camera, and the wound area was recorded using Image-Pro Plus 6.0 software. Wound size on the first day of treatment was considered to be 100%. The change in wound area size was compared to the initial before treatment and calculated as a percentage reduction.
次要结局
未报告次要终点
研究者
Rui Yin
MD, PhD
Army Medical University, China