Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound

This study has been completed.
Sponsor:
Collaborator:
National Science and Technology Development Agency, Thailand
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01553708
First received: February 28, 2012
Last updated: March 19, 2013
Last verified: March 2013
Results First Received: July 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Deep Partial Thickness Burn
Interventions: Drug: Epidermal growth factor with silver sulfadiazine cream
Drug: Silver zinc sulfadiazine cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All subjects were recruited between December 2011 to May 2012 at Burn Unit, Siriraj Hospital, Bangkok, Thailand.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The subjects were excluded if inclusion criteria was not met or the other treatment was assigned by the physician.

Reporting Groups
  Description
Epidermal Growth Factor With Silver Sulfadiazine Cream No text entered.
Silver Zinc Sulfadiazine Cream No text entered.

Participant Flow:   Overall Study
    Epidermal Growth Factor With Silver Sulfadiazine Cream     Silver Zinc Sulfadiazine Cream  
STARTED     17     17  
COMPLETED     17     17  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epidermal Growth Factor With Silver Sulfadiazine Cream No text entered.
Silver Zinc Sulfadiazine Cream No text entered.
Total Total of all reporting groups

Baseline Measures
    Epidermal Growth Factor With Silver Sulfadiazine Cream     Silver Zinc Sulfadiazine Cream     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     17     34  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.12  ± 13.72     37.71  ± 7.91     37.41  ± 12.41  
Gender  
[units: participants]
     
Female     5     3     8  
Male     12     14     26  
Region of Enrollment  
[units: participants]
     
Thailand     17     17     34  



  Outcome Measures

1.  Primary:   Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).   [ Time Frame: On 28th day after admission ]

2.  Secondary:   Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.   [ Time Frame: On 28th day after admission ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed and all samples have 18-60 years of age, this data cannot be applied for pediatrics.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Associate Prof. Pornanong Aramwit, Pharm.D., Ph.D.
Organization: Faculty of Pharmaceutical Sciences, Chulalongkorn University
phone: +66-02-218-8409
e-mail: paramwit@gmail.com


No publications provided


Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01553708     History of Changes
Other Study ID Numbers: CU0155
Study First Received: February 28, 2012
Results First Received: July 1, 2012
Last Updated: March 19, 2013
Health Authority: Thailand: Food and Drug Administration