Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424535
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-07
Brief Title:
Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 powderJinchuang ointmentZiyun ointment etc For internal medicineHuanglian Jiedu DecoctionQingying DecoctionXijiao Dihuang DecoctionTuoli Disinfection PowderShenling 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 SurgeryTraditional 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
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 SurgeryTraditional 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None