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

Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Deep Partial Thickness Burn

Intervention: Epidermal growth factor with silver sulfadiazine cream (Drug); Silver zinc sulfadiazine cream (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Chulalongkorn University

Official(s) and/or principal investigator(s):
Pornanong Aramwit, Pharm.D., Ph.D., Principal Investigator, Affiliation: Faculty of Pharmaceutical Sciences, Chulalongkorn University

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.

Clinical Details

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

Primary outcome: 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).

Secondary outcome: Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Burn Unit, Siriraj Hospital, Bangkok 10700, Thailand
Additional Information

Starting date: December 2011
Last updated: March 19, 2013

Page last updated: August 23, 2015

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