A Phase 4 interventional study of rhGM-CSF Gel in Deep Partial Thickness Burn, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Completed. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
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.
720 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's enrollment of 2,510 is above the median of 40 across 525 interventional studies indexed under Burns.
Browse Burns studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Drug: rhGM-CSF Gel
100% healing time of the wound surface
Time frame: 4 weeks
appearance of the wound surface
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
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
healing rate of the wound surface
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
Time frame: Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
Heart Rate
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
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
Body Temperature
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
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
Blood Pressure
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
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
Breathing Rate
If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.
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
Blood Routine
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.
Time frame: day 0, day 28
Urine Routine
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.
Time frame: day 0, day 28
liver Function
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.
Time frame: day 0, day 28
Renal Function
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.
Time frame: day 0, day 28
No study locations are listed for this record.
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Changchun GeneScience Pharmaceutical Co., Ltd.