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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Healing; Fibroblast Growth Factors
• Intervention / Treatment: Drug: basic fibroblast growth factor; Drug: Kangfuxin Liquid; Drug: 0.9% Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: huawei shao, MD; Phone Number: +86 13989880761; Email: 2504131@zju.edu.cn
• Study Contact Backup: Name: chunmao han, MD; Phone Number: +86 0571 87783759; Email: hanchunmao1@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: huawei shao, MD; Phone Number: +86 13989880761; Email: 2504131@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Nantong University; Taizhou Hospital; The Second Affiliated Hospital of Kunming Medical University; Lishui Country People's Hospital; Jiangyin Hospital Affiliated to Southeast University School of Medicine; The 59th Central Hospital of the Chinese people's Liberation Army; Zhejiang Quhua Hospital
• Investigators: Principal Investigator: huawei shao, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: basic fibroblast growth factor,Kangfuxin,Wound Healing
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: IR201900069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No