Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    300
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 24 February 2022
Accepts healthy volunteers

Summary

The main objective of this study is to observe whether basic fibroblast growth factor and Kangfuxin Liquid can promote the wound healing in the donor area and further evaluate the healing quality.

Details
Condition Fibroblast Growth Factors, Wound Healing
Treatment 0.9% normal saline, basic fibroblast growth factor, basic fibroblast growth factor, Kangfuxin Liquid
Clinical Study IdentifierNCT04234321
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male / female patients aged 20-50
Burn area 30% TBSA
Patients who need auto skin grafting due to burns or skin defects due to trauma
The donor area is 100cm2, and the thickness of skin is 0.25mm (Split thickness skin donor site group)/0.40mm (Medium thickness skin donor site group). The donor site is the body part with similar skin color and sufficient skin area (except scalp)
Not involved in clinical trials of other drugs
Subjects who have agreed to participate in the clinical study and signed the informed consent

Exclusion Criteria

Subjects who were previously allergic to similar products or related components of test products
Subjects with other systemic or local skin diseases that may affect wound evaluation
Subjects with significant organ dysfunction / failure or other serious diseases, including clinical related cardiovascular disease or myocardial infarction within 12 months before enrollment; malignant tumor; serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation
Subjects with moderate malnutrition (BMI < 17kg / m2) and severe anemia (HB < 60g / L)
Subjects proposed to use immunosuppressant, steroid hormone, epidermal growth factor and other drugs that may affect the wound healing of the donor skin within 3 months before admission or during the study period
Participated in clinical trials of any other drugs or medical devices within 3 months
History of major diseases that may affect general physical condition and other patients who are not considered by the researchers to be eligible for this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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