Clinical trial NCT01553708: Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Deep Partial Thickness Burn
Keywords: Wound healing
Epithelialization
Safety
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Development Agency, Thailand
First posted: 2012-03-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: On 28th day after admission
Secondary outcomes:
measure: Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.
timeFrame: On 28th day after admission
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Burn Unit, Siriraj Hospital
Study officials:
affiliation: Faculty of Pharmaceutical Sciences, Chulalongkorn University
name: Pornanong Aramwit, Pharm.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: