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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site

Conditions
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Fibroblast Growth Factors, Wound Healing

Intervention / Treatment
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* Drug: basic fibroblast growth factor
* Drug: Kangfuxin Liquid
* Drug: 0.9% Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: basic fibroblast growth factor<br>Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day. | Drug: basic fibroblast growth factor<br>* Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.<br>|
| Experimental: Kangfuxin Liquid<br>Kangfuxin Liquid,20ml / 100cm2 / time,three times a day. | Drug: Kangfuxin Liquid<br>* Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.<br>|
| Placebo Comparator: 0.9% Normal saline<br>0.9% Normal saline,20ml / 100cm2 / time,three times a day. | Drug: 0.9% Normal saline<br>* 0.9% Normal saline,20ml / 100cm2 / time,three times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing rate | Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%. | up to 2 or 3 weeks | 
| Actual healing time | Means time of complete wound healing | up to 2 or 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of scar formation | The degree of scar formation . | up to 3 or 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basic fibroblast growth factor,Kangfuxin,Wound Healing