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

Zhejiang University

Status: Unknown

Conditions: Wound Healing; Fibroblast Growth Factors

Treatments: Drug: 0.9% Normal saline; Drug: basic fibroblast growth factor; Drug: Kangfuxin Liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT04234321

IR201900069

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups, including a placebo group

basic fibroblast growth factor

Experimental group

Description:

Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.

Treatment:

Drug: basic fibroblast growth factor

Kangfuxin Liquid

Experimental group

Description:

Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.

Treatment:

Drug: Kangfuxin Liquid

0.9% Normal saline

Placebo Comparator group

Description:

0.9% Normal saline,20ml / 100cm2 / time,three times a day.

Treatment:

Drug: 0.9% Normal saline