Clinical trial NCT06424535: Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
Official title: Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns and Scalds
Keywords: Acupuncture
Chinese medicine
Burns
Scalds
Low level laser
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1:1 randomized controlled crossover study
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of TCM interventional treatment in shortening the recovery time and improving accompanying symptoms of burns and scalds. A single-center, randomized control crossover trial will compare TCM intervention to routine western medicine intervention.

Detailed description: Burns are an irreversible traumatic injury. When the skin suffers severe burns, it will cause a systemic shock to the individual. Although in recent years, with the advancement of medical technology, the mortality rate from burns and scalds has dropped significantly compared with the past, patients with burns and scalds also face many challenges during the treatment process, including having to endure the pain of the wound and the risk of infection during hospitalization. During the rehabilitation period after discharge, scarring, limb contracture, skin itching and appearance changes caused by burns and scalds will cause a significant decline in the patient's quality of life and lead to depression, withdrawal, social isolation and other phenomena. Traditional Chinese medicine is based on empirical medicine and the observation records of doctors. It has been passed down from generation to generation, and also have experience in treating fever. There are external and internal treatments for treating burns and scalds. External medicinal powders and ointments, such as Sanhuang powder,Jinchuang ointment,Ziyun ointment, etc. For internal medicine,Huanglian Jiedu Decoction,Qingying Decoction,Xijiao Dihuang Decoction,Tuoli Disinfection Powder,Shenling Baizhu Powder, etc. can be used according to different syndrome types. In addition, past studies have also confirmed that acupuncture can relieve burns and scalds and inhibit scar formation. Acupuncture can also improve gastrointestinal function and can be used to maintain good nutrient absorption in patients during the treatment of burns and scalds.

There are few large-scale studies on the joint treatment of burns and scalds between Chinese and Western medicine. Therefore, the purpose of this project is to compare the wound healing status and healing time between two groups that simply received conventional Western medicine treatment and conventional treatment plus interventional treatment with Chinese medicine. The study investigate traditional Chinese medicine interventional treatment model for mild to moderate burns and scalds, and hope to implement it clinically in the future to improve medical quality and treatment efficiency.

A single-center, randomized control crossover trial. This study will be conducted at the Burn and Scald Center and Plastic Surgery/Traditional Chinese Medicine Clinic of China Medical University Hospital. When patients seek medical treatment for burns and scalds, they will be evaluated by a plastic surgeon and randomly assigned into two groups. One group will receive conventional Western medicine treatment plus TCM intervention. Different treatment strategies will be adopted depending on the severity of the condition, and the first assessment will be conducted before TCM interventional treatment. , a post-test was conducted four weeks after treatment. Afterward, the two groups will be alternated. The group that did not receive TCM intervention received TCM interventional treatment for four weeks, while the other group received only conventional Western medicine treatment. The assessment items included: assessment of wound and pain status. Pain status was assessed using the Visual Analogue Scale (VAS), and scars were assessed using the Vancouver Scar Scale (VSS). Assess, and record critical indicators according to clinical needs, such as caloric requirement (kcal), daily fluid requirement (ml), daily urine output (ml) and other physiological parameters, and record the burn area (Modified Lund-Browder chart) and depth. The control group will be treated with conventional Western medicine. Outcome measurements will be assessed at baseline, 4 weeks, and 4 weeks after crossover (8 weeks). The goal of our study is to measure the effectiveness of TCM interventional treatment in shortening recovery time and improving accompanying symptoms of burns and scalds.

Eligibility criteria: Inclusion Criteria:

* Age：20-90.
* Patients with mild to moderate injuries and burns that meet the American Burn Association (ABA) injury classification.

Exclusion Criteria:

* Patients refuse TCM intervention.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
measure: Vancouver Scar Scale
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Secondary outcomes:
measure: Caloric intake per day
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
measure: Daily fluid requirement (ml)
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
measure: Daily urine output
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
measure: Lund-Browder chart
timeFrame: At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: