Deep Partial Thickness Burn
Conditions
Keywords
Wound healing, Epithelialization, Safety
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.
Interventions
DRUGEpidermal 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)
DRUGSilver 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)
Sponsors
National Science and Technology Development Agency, Thailand
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound. | 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. |
Countries
Thailand
Participant flow
Recruitment details
All subjects were recruited between December 2011 to May 2012 at Burn Unit, Siriraj Hospital, Bangkok, Thailand.
Pre-assignment details
The subjects were excluded if inclusion criteria was not met or the other treatment was assigned by the physician.
Participants by arm
| Arm | Count |
|---|---|
| Epidermal Growth Factor With Silver Sulfadiazine Cream | 17 |
| Silver Zinc Sulfadiazine Cream | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Silver Zinc Sulfadiazine Cream | Epidermal Growth Factor With Silver Sulfadiazine Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Age Continuous | 37.71 years STANDARD_DEVIATION 7.91 | 37.12 years STANDARD_DEVIATION 13.72 | 37.41 years STANDARD_DEVIATION 12.41 |
| Region of Enrollment Thailand | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
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.
Time frame: On 28th day after admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidermal Growth Factor With Silver Sulfadiazine Cream | 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). | 23.06 Days | Standard Deviation 5.21 |
| Silver Zinc Sulfadiazine Cream | 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). | 30.94 Days | Standard Deviation 7.34 |
Secondary
Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.
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.
Time frame: On 28th day after admission