Fibroblast Growth Factors, Wound Healing
Conditions
Keywords
basic fibroblast growth factor,Kangfuxin,Wound Healing
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.
Interventions
DRUGbasic fibroblast growth factor
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
DRUGKangfuxin Liquid
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
DRUG0.9% Normal saline
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Jiangyin Hospital Affiliated to Southeast University School of Medicine
Nantong University
The 59th Central Hospital of the Chinese people's Liberation Army
Taizhou Hospital
Zhejiang Quhua Hospital
Lishui Country People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Degree of scar formation | up to 3 or 12 weeks | The degree of scar formation . |
Countries
China
Contacts
Primary Contacthuawei shao, MD
Backup Contactchunmao han, MD
Outcome results
None listed