Research on the Key Technology of Burn Wound Treatment

Not Applicable

• Conditions: Burn
• Interventions: Procedure: Routine dressing change; Procedure: Limited debridement & Epidermal cell spraying; Procedure: Limited debridement & Acellular dermal matrix dressing; Procedure: Limited debridement & Basic fibroblast growth factor

• Registration Number: NCT03279549
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27
• Study Start: 2018-07-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dressing change group	Routine dressing change	Routine dressing change group
Epidermal cell spraying group	Limited debridement & Epidermal cell spraying	Limited debridement \& Epidermal cell spraying group
Dermal matrix dressing group	Limited debridement & Acellular dermal matrix dressing	Limited debridement \& Acellular dermal matrix dressing group.
BFGF group	Limited debridement & Basic fibroblast growth factor	Limited debridement \& Basic fibroblast growth factor group

Primary Outcome Measures

Name	Time	Method
Wound healing time	21 days after treatment	Healing time is the number of days when the wound healed completely after management.

Secondary Outcome Measures

Name	Time	Method
Scar formation	6 months after treatment	Vancouver scar score
Wound healing rate	21 days after treatment	Wound healing rate =（area before management - area after management）/ area before management×100%.