Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
NCT ID: NCT04234321
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-08-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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basic fibroblast growth factor
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
basic fibroblast growth factor
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
Kangfuxin Liquid
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
Kangfuxin Liquid
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
0.9% Normal saline
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
0.9% Normal saline
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
Interventions
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basic fibroblast growth factor
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
Kangfuxin Liquid
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
0.9% Normal saline
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
50 Years
ALL
Yes
Sponsors
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The Second Affiliated Hospital of Kunming Medical University
OTHER
Jiangyin Hospital Affiliated to Southeast University School of Medicine
UNKNOWN
Nantong University
OTHER
The 59th Central Hospital of the Chinese people's Liberation Army
UNKNOWN
Taizhou Hospital
OTHER
Zhejiang Quhua Hospital
OTHER
Lishui Country People's Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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huawei shao, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR201900069
Identifier Type: -
Identifier Source: org_study_id
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