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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234321
• Other study ID #: IR201900069
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: huawei shao, MD
• Phone: 13989880761
• Email: 2504131[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibroblast Growth Factors
• Wound Healing

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (8)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Jiangyin Hospital Affiliated to Southeast University School of Medicine, Lishui Country People's Hospital, Nantong University, Taizhou Central Hospital (Taizhou University Hospital), The 59th Central Hospital of the Chinese people's Liberation Army, The Second Affiliated Hospital of Kunming Medical University, Zhejiang Quhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing rate	Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%.	up to 2 or 3 weeks
Primary	Actual healing time	Means time of complete wound healing	up to 2 or 3 weeks
Secondary	Degree of scar formation	The degree of scar formation .	up to 3 or 12 weeks