Research on the Key Technology of Burn Wound Treatment

Burn Clinical Trial

Official title:

A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03279549
• Other study ID #: KY20140709-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2018
• Source: Xijing Hospital
• Contact: Hu Dahai, Doctor
• Phone: 029-84775293
• Email: hudhai[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Procedure:
• Routine 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.
• Limited 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.
• Limited 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.
• Limited 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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Xijing Hospital	Beijing Jishuitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Ruijin Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Southwest Hospital, China, Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	Healing time is the number of days when the wound healed completely after management.	21 days after treatment
Secondary	Wound healing rate	Wound healing rate =(area before management - area after management)/ area before management×100%.	21 days after treatment
Secondary	Scar formation	Vancouver scar score	6 months after treatment