Burn
Conditions
Brief summary
Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.
Interventions
PROCEDURERoutine dressing change
Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.
PROCEDURELimited debridement & Acellular dermal matrix dressing
In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.
PROCEDURELimited debridement & Epidermal cell spraying
In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site.
PROCEDURELimited debridement & Basic fibroblast growth factor
In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds.
Sponsors
Beijing Jishuitan Hospital
First Hospitals affiliated to the China PLA General Hospital
Ruijin Hospital
Southwest Hospital, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Xiangya Hospital of Central South University
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Area of deep second burn wound \>=10cm×10cm，total burn area ≤50% TBSA. 2. Within 96 hours after burns and could be managed within 24 hours after included. 3. Ages from 18 to 60. 4. No serious breathing, circulation and other systemic diseases, no surgical contraindications. 5. Agrees to participate in this trial and has signed an informed consent form.
Exclusion criteria
1. Have severe inhalation injury or shock, or acute respiratory failure； 2. There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease; 3. Susceptible to allergies； 4. Islamic believers 5. Pregnant women 6. Other cases that are not suitable for study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing time | 21 days after treatment | Healing time is the number of days when the wound healed completely after management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing rate | 21 days after treatment | Wound healing rate =（area before management - area after management）/ area before management×100%. |
| Scar formation | 6 months after treatment | Vancouver scar score |
Contacts
Primary ContactHu Dahai, Doctor
Outcome results
None listed