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

March 19, 2013 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10700
        • Burn Unit, Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.
Time Frame: On 28th day after admission
  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.
On 28th day after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pornanong Aramwit, Pharm.D., Ph.D., Faculty of Pharmaceutical Sciences, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 11, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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