Clinical trial NCT04234321: Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
Official title: A Multicenter, Prospective Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibroblast Growth Factors
Wound Healing
Keywords: basic fibroblast growth factor,Kangfuxin,Wound Healing
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Kunming Medical University
name: Jiangyin Hospital Affiliated to Southeast University School of Medicine
name: Nantong University
name: The 59th Central Hospital of the Chinese people's Liberation Army
name: Taizhou Hospital
name: Zhejiang Quhua Hospital
name: Lishui Country People's Hospital
First posted: 2020-01-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wound healing rate
timeFrame: up to 2 or 3 weeks
measure: Actual healing time
timeFrame: up to 2 or 3 weeks
Secondary outcomes:
measure: Degree of scar formation
timeFrame: up to 3 or 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: huawei shao, MD
role: PRINCIPAL_INVESTIGATOR
References: