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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
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

    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
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    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

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    Research on the Key Technology of Burn Wound Treatment

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