Research on the Key Technology of Burn Wound Treatment

NCT ID: NCT03279549

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-09-30

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dressing change group

Routine dressing change group

Group Type: ACTIVE_COMPARATOR

Routine dressing change

Intervention Type: PROCEDURE

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.

Dermal matrix dressing group

Limited debridement \& Acellular dermal matrix dressing group.

Group Type: EXPERIMENTAL

Limited debridement & Acellular dermal matrix dressing

Intervention Type: PROCEDURE

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.

Epidermal cell spraying group

Limited debridement \& Epidermal cell spraying group

Group Type: EXPERIMENTAL

Limited debridement & Epidermal cell spraying

Intervention Type: PROCEDURE

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.

BFGF group

Limited debridement \& Basic fibroblast growth factor group

Group Type: EXPERIMENTAL

Limited debridement & Basic fibroblast growth factor

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Jishuitan Hospital

OTHER

Sponsor Role: collaborator

First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Southwest Hospital, China

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hu Dahai

Director of Burn Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xie Songtao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Central Contacts

Hu Dahai, Doctor

Role: CONTACT

hudhai@fmmu.edu.cn

029-84775293

Other Identifiers

KY20140709-1

Identifier Type: -

Identifier Source: org_study_id