Research on the Key Technology of Burn Wound Treatment
A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJune 27, 2018
June 1, 2018
6 months
September 5, 2017
June 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Wound healing time
Healing time is the number of days when the wound healed completely after management.
21 days after treatment
Secondary Outcomes (2)
Wound healing rate
21 days after treatment
Scar formation
6 months after treatment
Study Arms (4)
dressing change group
ACTIVE COMPARATORRoutine dressing change group
Dermal matrix dressing group
EXPERIMENTALLimited debridement \& Acellular dermal matrix dressing group.
Epidermal cell spraying group
EXPERIMENTALLimited debridement \& Epidermal cell spraying group
BFGF group
EXPERIMENTALLimited debridement \& Basic fibroblast growth factor group
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Area of deep second burn wound \>=10cm×10cm，total burn area ≤50% TBSA.
- Within 96 hours after burns and could be managed within 24 hours after included.
- Ages from 18 to 60.
- No serious breathing, circulation and other systemic diseases, no surgical contraindications.
- Agrees to participate in this trial and has signed an informed consent form.
You may not qualify if:
- Have severe inhalation injury or shock, or acute respiratory failure；
- There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
- Susceptible to allergies；
- Islamic believers
- Pregnant women
- Other cases that are not suitable for study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
- Beijing Jishuitan Hospitalcollaborator
- First Hospitals affiliated to the China PLA General Hospitalcollaborator
- Ruijin Hospitalcollaborator
- Southwest Hospital, Chinacollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xie Songtao, Doctor
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Burn Center
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 12, 2017
Study Start
July 1, 2018
Primary Completion
December 31, 2018
Study Completion
September 30, 2019
Last Updated
June 27, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share