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

February 5, 2013 updated by: GeneScience Pharmaceuticals Co., Ltd.

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

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2510

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Liao Zh Jiang, Doctor, Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

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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