Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Moist exposed burn ointment versus povidone iodine plus bepanthenol for patients with moderate burns (TBSA<15%)
Acronym
Study hypothesis
Moist exposed burn ointment (MEBO) substantially reduces the time of wound healing.
Further reading:
http://www.ncbi.nlm.nih.gov/pubmed/20121563
Ethics approval
Scientific Committee of General Regional Hospital of Athens, Dr. Georgios Papastratis approved on the 1st of February 200 (ref: 199/2000)
Study design
Prospective pragmatic randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Prof V. Carayanni [bilma@otenet.gr] to request a patient information sheet
Condition
Burns
Intervention
Patients will be randomised to receive either:
1. Moist exposed burn ointment (MEBO), applied twice per day with the assistance of nursing staff
2. Povidone iodine plus bepanthenol. Bepanthenol cream is self applied or applied with the assistance of nursing personnel twice per day after the third or fourth day of therapy with povidone iodine according to the degree of repithelilization.
The burn wounds (both groups) were also treated and lightly debrided by antiseptic in the shower every second day by nursing or medical personnel. Also, dressing of the burn wounds during hospitalization is not applicable primarily because of considerable shortcomings in nursing personnel.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
1. Mean reduction in days of in-hospital stay for patients in both groups (standard length of stay according to the experts=10 days)
2. Time of recovery for patients with superficial partial thickness burns (Transepidermal Water Loss [TEWL] <60 gr/m2/h) using the TEWL indicator, recovery defined as 50% reduction of the TEWL on the first day
Secondary outcome measures
1. Pain
A visual analogue scale of 1 to 10 is used for pain measurement (0 = no pain; 1-2 = slight pain; 3-4 = mild pain; 5 = moderate pain; 6-9 = moderately severe pain; 10 = severe pain). Pain scores were recorded twice daily by the doctors. Pain medication is given upon patient demand
2. Clinical evaluation of the appearance of burn limits
A clinical evaluation of the appearance of burn limits is made each day by the doctor. We have used a binary and a continuous variable to quantify these criteria. The modalities of the first variable are:
2.1. Healthy appearance of burn limits
2.2. No Healthy appearance (presenting redness, swelling, other)
Overall trial start date
05/01/2002
Overall trial end date
05/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Total Burns Surface Area (TBSA) <15%.
2. Thermal burns
3. No need of surgical operation
4. Either sex, aged 18-75
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
214
Participant exclusion criteria
Systematic diseases (cancer and diabetes)
Recruitment start date
05/01/2002
Recruitment end date
05/01/2006
Locations
Countries of recruitment
Greece
Trial participating centre
Department of Plastic Surgery, Microsurgery and Burn Center, General State Hospital of Athens G. Gennimatas, 154 Mesogion Avenue Greece
Athens
11141
Greece
Funders
Funder type
Hospital/treatment centre
Funder name
Regional General Hospital of Athens Georgios Gennimatas (Greece) - Department of Plastic Surgery, Microsurgery and Burn Center (equipment, stock medicines [except MEBO], and personnel
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
MEBO International Group Company (MEBO medicines) (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list