Research on the Key Technology of Burn Wound Treatment

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Burn

Treatments: Procedure: Limited debridement & Basic fibroblast growth factor; Procedure: Limited debridement & Acellular dermal matrix dressing; Procedure: Routine dressing change; Procedure: Limited debridement & Epidermal cell spraying

Study type: Interventional

Funder types: Other

Identifiers

NCT03279549

KY20140709-1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

dressing change group

Active Comparator group

Description:

Routine dressing change group

Treatment:

Procedure: Routine dressing change

Dermal matrix dressing group

Experimental group

Description:

Limited debridement \& Acellular dermal matrix dressing group.

Treatment:

Procedure: Limited debridement & Acellular dermal matrix dressing

Epidermal cell spraying group

Experimental group

Description:

Limited debridement \& Epidermal cell spraying group

Treatment:

Procedure: Limited debridement & Epidermal cell spraying

BFGF group

Experimental group

Description:

Limited debridement \& Basic fibroblast growth factor group

Treatment:

Procedure: Limited debridement & Basic fibroblast growth factor