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

Deep Partial Thickness Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553708
• Other study ID #: CU0155
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 28, 2012
• Last updated: March 19, 2013
• Start date: December 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Deep Partial Thickness Burn

Intervention

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)
• 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)

Locations

Country	Name	City	State
Thailand	Burn Unit, Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	National Science and Technology Development Agency, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 (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.	On 28th day after admission	Yes
Secondary	Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.	Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.; % Wound contraction.; Time and type of analgesic or itching medication after treatment.; 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.; Adverse reaction such as swelling, edema and redness at wound site.	On 28th day after admission	Yes