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

Not Applicable

• Conditions: Fibroblast Growth Factors; Wound Healing
• Interventions: Drug: 0.9% Normal saline; Drug: Kangfuxin Liquid; Drug: basic fibroblast growth factor

• Registration Number: NCT04234321
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12
• Study Start: 2020-08-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Normal saline	0.9% Normal saline	0.9% Normal saline,20ml / 100cm2 / time,three times a day.
Kangfuxin Liquid	Kangfuxin Liquid	Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
basic fibroblast growth factor	basic fibroblast growth factor	Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Degree of scar formation	up to 3 or 12 weeks	The degree of scar formation .

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China