- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785784
Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn (rhGM-CSF)
Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn
This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn.
There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age is not less than 3 years old, any gender is ok.
- the subject who is diagnosed as deep 2nd thickness burn
- the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study.
- the subject who sign the <informed consent>
Exclusion Criteria:
- age is less than 3 years old
- the subject who participated in any other clinical trial within 3 months
- the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study
- the female subject who is in lactation or pregnancy
- the subject who are allergic to rhGM-CSF, or has the allergic history to many drug products or has the allergic disease recently
- the subject who has serious heart disease, unstable angina pectoris break out, cardiac functional insufficiency, myocardial infarction or serious general infection.
- the subject who has serious renal inadequacy, creatinine(Cr) is more than 2.5 times of the upper limit
- aspartate aminotransferase or alanine transpeptidase is more than 2.5 times of the upper limit
- the subject who use immunosuppressant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: burn patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
100% healing time of the wound surface
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
appearance of the wound surface
Time Frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
healing rate of the wound surface
Time Frame: Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
Body Temperature
Time Frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
Blood Pressure
Time Frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
Breathing Rate
Time Frame: day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
|
day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28
|
Blood Routine
Time Frame: day 0, day 28
|
Blood routine should be tested before administration and after the last administration.
If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.
|
day 0, day 28
|
Urine Routine
Time Frame: day 0, day 28
|
Urine routine should be tested before administration and after the last administration.
If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.
|
day 0, day 28
|
liver Function
Time Frame: day 0, day 28
|
Liver function should be tested before administration and after the last administration.
If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.
|
day 0, day 28
|
Renal Function
Time Frame: day 0, day 28
|
Renal function should be tested before administration and after the last administration.
If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.
|
day 0, day 28
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Liao Zh Jiang, Doctor, Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GenSci-002-CT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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