Research on the Key Technology of Burn Wound Treatment
Primary Purpose
Burn
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Routine dressing change
Limited debridement & Acellular dermal matrix dressing
Limited debridement & Epidermal cell spraying
Limited debridement & Basic fibroblast growth factor
Sponsored by
About this trial
This is an interventional treatment trial for Burn
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
dressing change group
Dermal matrix dressing group
Epidermal cell spraying group
BFGF group
Arm Description
Routine dressing change group
Limited debridement & Acellular dermal matrix dressing group.
Limited debridement & Epidermal cell spraying group
Limited debridement & Basic fibroblast growth factor group
Outcomes
Primary Outcome Measures
Wound healing time
Healing time is the number of days when the wound healed completely after management.
Secondary Outcome Measures
Wound healing rate
Wound healing rate =(area before management - area after management)/ area before management×100%.
Scar formation
Vancouver scar score
Full Information
NCT ID
NCT03279549
First Posted
September 5, 2017
Last Updated
June 25, 2018
Sponsor
Xijing Hospital
Collaborators
Beijing Jishuitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Ruijin Hospital, Southwest Hospital, China, Second Affiliated Hospital, School of Medicine, Zhejiang University, Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03279549
Brief Title
Research on the Key Technology of Burn Wound Treatment
Official Title
A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
Collaborators
Beijing Jishuitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Ruijin Hospital, Southwest Hospital, China, Second Affiliated Hospital, School of Medicine, Zhejiang University, Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dressing change group
Arm Type
Active Comparator
Arm Description
Routine dressing change group
Arm Title
Dermal matrix dressing group
Arm Type
Experimental
Arm Description
Limited debridement & Acellular dermal matrix dressing group.
Arm Title
Epidermal cell spraying group
Arm Type
Experimental
Arm Description
Limited debridement & Epidermal cell spraying group
Arm Title
BFGF group
Arm Type
Experimental
Arm Description
Limited debridement & Basic fibroblast growth factor group
Intervention Type
Procedure
Intervention Name(s)
Routine dressing change
Intervention Description
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
Intervention Name(s)
Limited debridement & Acellular dermal matrix dressing
Intervention Description
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
Intervention Name(s)
Limited debridement & Epidermal cell spraying
Intervention Description
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
Intervention Name(s)
Limited debridement & Basic fibroblast growth factor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing time
Description
Healing time is the number of days when the wound healed completely after management.
Time Frame
21 days after treatment
Secondary Outcome Measure Information:
Title
Wound healing rate
Description
Wound healing rate =(area before management - area after management)/ area before management×100%.
Time Frame
21 days after treatment
Title
Scar formation
Description
Vancouver scar score
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu Dahai, Doctor
Phone
029-84775293
Email
hudhai@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xie Songtao, Doctor
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Research on the Key Technology of Burn Wound Treatment
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