Clinical trial NCT03279549: Research on the Key Technology of Burn Wound Treatment
Official title: A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
name: First Hospitals affiliated to the China PLA General Hospital
name: Ruijin Hospital
name: Southwest Hospital, China
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiangya Hospital of Central South University
First posted: 2017-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound healing time
timeFrame: 21 days after treatment
Secondary outcomes:
measure: Wound healing rate
timeFrame: 21 days after treatment
measure: Scar formation
timeFrame: 6 months after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Xie Songtao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: