Fibroblast Growth FactorsNCT04234321
Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
A study testing basic fibroblast growth factor, Kangfuxin Liquid and 0.9% Normal saline in people with Fibroblast Growth Factors and Wound Healing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibroblast Growth Factors, Wound Healing
- What is being tested?
- basic fibroblast growth factor, Kangfuxin Liquid and 0.9% Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
huawei shao, MD, 13989880761 ext. +86, 2504131@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Fibroblast Growth Factors, Wound Healing
- Being tested
- basic fibroblast growth factor, Kangfuxin Liquid, 0.9% Normal saline
- Keywords
- basic fibroblast growth factor,Kangfuxin,Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basic fibroblast growth factorDrug
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
Kangfuxin LiquidDrug
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
0.9% Normal salineDrug
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
| Study group | Role | What they receive |
|---|---|---|
| basic fibroblast growth factor | Experimental | Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day. Receives: Drug: basic fibroblast growth factor |
| Kangfuxin Liquid | Experimental | Kangfuxin Liquid,20ml / 100cm2 / time,three times a day. Receives: Drug: Kangfuxin Liquid |
| 0.9% Normal saline | Placebo comparator | 0.9% Normal saline,20ml / 100cm2 / time,three times a day. Receives: Drug: 0.9% Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing rate
Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%.
Measured: up to 2 or 3 weeks
Actual healing time
Means time of complete wound healing
Measured: up to 2 or 3 weeks
Secondary outcomes (1)
Degree of scar formation
The degree of scar formation .
Measured: up to 3 or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Aug 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroblast Growth FactorsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- huawei shao, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234321
- Sponsor's protocol ID
- IR201900069
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
- ClinicalTrials.gov ID
- NCT04234321
- Acronym / sponsor ID
- IR201900069
- Conditions
- Fibroblast Growth Factors, Wound Healing
- Keywords
- basic fibroblast growth factor,Kangfuxin,Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| basic fibroblast growth factor | Experimental | Drug: basic fibroblast growth factorBasic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day. |
| Kangfuxin Liquid | Experimental | Drug: Kangfuxin LiquidKangfuxin Liquid,20ml / 100cm2 / time,three times a day. |
| 0.9% Normal saline | Placebo comparator | Drug: 0.9% Normal saline0.9% Normal saline,20ml / 100cm2 / time,three times a day. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| basic fibroblast growth factorBasic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day. | Drug | basic fibroblast growth factor |
| Kangfuxin LiquidKangfuxin Liquid,20ml / 100cm2 / time,three times a day. | Drug | Kangfuxin Liquid |
| 0.9% Normal saline0.9% Normal saline,20ml / 100cm2 / time,three times a day. | Drug | 0.9% Normal saline |
Primary outcome
Wound healing rate
Time frame: up to 2 or 3 weeks
Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%.
Actual healing time
Time frame: up to 2 or 3 weeks
Means time of complete wound healing
1 secondary outcome
Degree of scar formation
Time frame: up to 3 or 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huawei shao, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing basic fibroblast growth factor, Kangfuxin Liquid and 0.9% Normal saline in people with Fibroblast Growth Factors and Wound Healing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huawei shao, MD (13989880761 ext. +86, 2504131@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing rate (time frame: up to 2 or 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.