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Research on the Key Technology of Burn Wound Treatment

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ClinicalTrials.gov Identifier: NCT03279549
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : June 27, 2018
Sponsor:
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
Information provided by (Responsible Party):
Hu Dahai, Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Burn Procedure: Routine dressing change Procedure: Limited debridement & Acellular dermal matrix dressing Procedure: Limited debridement & Epidermal cell spraying Procedure: Limited debridement & Basic fibroblast growth factor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dressing change group
Routine dressing change group
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.

Experimental: Dermal matrix dressing group
Limited debridement & Acellular dermal matrix dressing group.
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.

Experimental: Epidermal cell spraying group
Limited debridement & Epidermal cell spraying group
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.

Experimental: BFGF group
Limited debridement & Basic fibroblast growth factor group
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.




Primary Outcome Measures :
  1. Wound healing time [ Time Frame: 21 days after treatment ]
    Healing time is the number of days when the wound healed completely after management.


Secondary Outcome Measures :
  1. Wound healing rate [ Time Frame: 21 days after treatment ]
    Wound healing rate =(area before management - area after management)/ area before management×100%.

  2. Scar formation [ Time Frame: 6 months after treatment ]
    Vancouver scar score



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279549


Contacts
Contact: Hu Dahai, Doctor 029-84775293 hudhai@fmmu.edu.cn

Sponsors and Collaborators
Xijing Hospital
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
Investigators
Principal Investigator: Xie Songtao, Doctor Xijing Hospital

Responsible Party: Hu Dahai, Director of Burn Center, Xijing Hospital
ClinicalTrials.gov Identifier: NCT03279549     History of Changes
Other Study ID Numbers: KY20140709-1
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action