Clinical trial NCT01785784: Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn
Official title: Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Partial Thickness Burn
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Beijing Children's Hospital
name: Third Military Medical University
First posted: 2013-02-07
Enrollment: 2510
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 100% healing time of the wound surface
timeFrame: 4 weeks
Secondary outcomes:
measure: appearance of the wound surface
timeFrame: 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
measure: healing rate of the wound surface
timeFrame: Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28
Other outcomes:
measure: Heart Rate
timeFrame: 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
measure: Body Temperature
timeFrame: 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
measure: Blood Pressure
timeFrame: 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
measure: Breathing Rate
timeFrame: 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
measure: Blood Routine
timeFrame: day 0, day 28
measure: Urine Routine
timeFrame: day 0, day 28
measure: liver Function
timeFrame: day 0, day 28
measure: Renal Function
timeFrame: day 0, day 28
Locations:
Study officials:
affiliation: Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
name: Liao Zh Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: