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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

February 28, 2012
March 19, 2013
December 2011
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.
Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization. [ Time Frame: On 28th day after admission ] [ Designated as safety issue: Yes ]
Time for complete epithelialization is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.
Complete list of historical versions of study NCT01553708 on ClinicalTrials.gov Archive Site
Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound. [ Time Frame: On 28th day after admission ] [ Designated as safety issue: Yes ]
  1. Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.
  2. % Wound contraction.
  3. Time and type of analgesic or itching medication after treatment.
  4. Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes or any systemic effect after treatment.
  5. Adverse reaction such as swelling, edema and redness at wound site.
Same as current
Not Provided
Not Provided
 
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound
The Clinical Efficacy of Epidermal Growth Factor With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream on Acceleration of Partial Thickness Burn Wound Healing

Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of epithelialization. However, it depends on the depth of the wounds and patient condition. Infection is one of the most common complications causing delay in wound healing which might affect to quality of patient's life. Generally, the standard treatment of partial thickness burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate the accelerating effect of wound healing. Therefore, the combination of substance which can promote wound healing to topical silver sulfadiazine cream might benefit for partial thickness burn wound treatment.

The objective of this study was to compare the results of partial thickness burn wound treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type of pain and itching medication, adverse effect of topical medication, some laboratory results and cost of expenses.

This is the prospective, double blinded, randomize-controlled study. The sample sizes were partial thickness burn wound patients who were treated at burn unit, Siriraj hospital. Patients were allocated into 2 groups receiving treatment with either topical silver sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with repeated measure ANOVA and independent t-test.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Deep Partial Thickness Burn
  • Drug: Epidermal growth factor with silver sulfadiazine cream
    Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)
  • Drug: Silver zinc sulfadiazine cream
    Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)
  • Experimental: Epidermal growth factor with silver sulfadiazine cream
    Epidermal growth factor with silver sulfadiazine cream was applied to the experimental wounds completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.
    Intervention: Drug: Epidermal growth factor with silver sulfadiazine cream
  • Active Comparator: Silver zinc sulfadiazine cream
    Silver sulfadiazine cream was applied to cover the controlled-wound completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.
    Intervention: Drug: Silver zinc sulfadiazine cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18-60 years.
  • Partial thickness burn wound more than 20%TBSA.
  • No underlying diseases that interfere wound healing such as chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency.
  • In case of reproductive age woman, they have to control the birth rate at least 4 weeks before study.
  • Patients who are willing to participate in the trial and to sign the informed consent form.

Exclusion Criteria:

  • Immunocompromised defects
  • Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
  • Pregnancy or lactation
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01553708
CU0155
Yes
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
Chulalongkorn University
National Science and Technology Development Agency, Thailand
Principal Investigator: Pornanong Aramwit, Pharm.D., Ph.D. Faculty of Pharmaceutical Sciences, Chulalongkorn University
Chulalongkorn University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP