Trial Outcomes & Findings for Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound (NCT NCT01553708)
NCT ID: NCT01553708
Last Updated: 2013-03-25
Results Overview
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.
COMPLETED
PHASE2/PHASE3
34 participants
On 28th day after admission
2013-03-25
Participant Flow
All subjects were recruited between December 2011 to May 2012 at Burn Unit, Siriraj Hospital, Bangkok, Thailand.
The subjects were excluded if inclusion criteria was not met or the other treatment was assigned by the physician.
Participant milestones
| Measure |
Epidermal Growth Factor With Silver Sulfadiazine Cream
|
Silver Zinc Sulfadiazine Cream
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound
Baseline characteristics by cohort
| Measure |
Epidermal Growth Factor With Silver Sulfadiazine Cream
n=17 Participants
|
Silver Zinc Sulfadiazine Cream
n=17 Participants
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
37.12 years
STANDARD_DEVIATION 13.72 • n=39 Participants
|
37.71 years
STANDARD_DEVIATION 7.91 • n=41 Participants
|
37.41 years
STANDARD_DEVIATION 12.41 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Region of Enrollment
Thailand
|
17 participants
n=39 Participants
|
17 participants
n=41 Participants
|
34 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: On 28th day after admissionTime (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.
Outcome measures
| Measure |
Epidermal Growth Factor With Silver Sulfadiazine Cream
n=17 Participants
Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
|
Silver Zinc Sulfadiazine Cream
n=17 Participants
Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
|
|---|---|---|
|
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 • Interval 19.0 to 28.0
|
30.94 Days
Standard Deviation 7.34 • Interval 23.0 to 38.0
|
SECONDARY outcome
Timeframe: On 28th day after admission1. 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.
Outcome measures
Outcome data not reported
Adverse Events
Epidermal Growth Factor With Silver Sulfadiazine Cream
Silver Zinc Sulfadiazine Cream
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Prof. Pornanong Aramwit, Pharm.D., Ph.D.
Faculty of Pharmaceutical Sciences, Chulalongkorn University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place