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Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn (rhGM-CSF)

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ClinicalTrials.gov Identifier: NCT01785784
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Beijing Children's Hospital
Third Military Medical University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Deep Partial Thickness Burn Drug: rhGM-CSF Gel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn
Study Start Date : November 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: burn patients Drug: rhGM-CSF Gel



Primary Outcome Measures :
  1. 100% healing time of the wound surface [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785784


Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Shanghai Jiao Tong University School of Medicine
Beijing Children's Hospital
Third Military Medical University
Investigators
Principal Investigator: Liao Zh Jiang, Doctor Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01785784     History of Changes
Other Study ID Numbers: GenSci-002-CT
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Burns
Wounds and Injuries