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

Primary Purpose

Deep Partial Thickness Burn

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Epidermal growth factor with silver sulfadiazine cream
Silver zinc sulfadiazine cream
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Partial Thickness Burn focused on measuring Wound healing, Epithelialization, Safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burn Unit, Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epidermal growth factor with silver sulfadiazine cream

Silver zinc sulfadiazine cream

Arm Description

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.

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.

Outcomes

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 (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.
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.

Full Information

First Posted
February 28, 2012
Last Updated
March 19, 2013
Sponsor
Chulalongkorn University
Collaborators
National Science and Technology Development Agency, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01553708
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
National Science and Technology Development Agency, Thailand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Partial Thickness Burn
Keywords
Wound healing, Epithelialization, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidermal growth factor with silver sulfadiazine cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Silver zinc sulfadiazine cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epidermal growth factor with silver sulfadiazine cream
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Silver zinc sulfadiazine cream
Intervention Description
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)
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
On 28th day after admission
Secondary Outcome Measure Information:
Title
Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.
Description
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.
Time Frame
On 28th day after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Pharm.D., Ph.D.
Organizational Affiliation
Faculty of Pharmaceutical Sciences, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burn Unit, Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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