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
  Purpose

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.


Condition Intervention Phase
Deep Partial Thickness Burn
Drug: Epidermal growth factor with silver sulfadiazine cream
Drug: Silver zinc sulfadiazine cream
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 34
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553708

Locations
Thailand
Burn Unit, Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Chulalongkorn University
National Science and Technology Development Agency, Thailand
Investigators
Principal Investigator: Pornanong Aramwit, Pharm.D., Ph.D. Faculty of Pharmaceutical Sciences, Chulalongkorn University
  More Information

No publications provided

Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01553708     History of Changes
Other Study ID Numbers: CU0155
Study First Received: February 28, 2012
Results First Received: July 1, 2012
Last Updated: March 19, 2013
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
Wound healing
Epithelialization
Safety

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Mitogens
Silver Sulfadiazine
Sulfadiazine
Zinc
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014