Comparing oil based ointment versus standard practice for the treatment of moderate burns in Greece: A cost effectiveness evaluation

ISRCTN	ISRCTN74058791
DOI	https://doi.org/10.1186/ISRCTN74058791
Protocol serial number	N/A
Sponsor	Regional General Hospital of Athens Georgios Gennimatas (Greece)
Funders	Regional General Hospital of Athens Georgios Gennimatas (Greece) - Department of Plastic Surgery, Microsurgery and Burn Center (equipment, stock medicines [except MEBO], and personnel, MEBO International Group Company (MEBO medicines) (China)

Submission date: 23/10/2010
Registration date: 12/11/2010
Last edited: 18/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ioannis Ioannovits
Scientific

Department of Plastic Surgery, Microsurgery and Burn Center, General State Hospital of Athens G. Gennimatas, 154 Mesogion Avenue Greece
Athens
11141
Greece

Study information

Primary study design	Interventional
Study design	Prospective pragmatic randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Moist exposed burn ointment versus povidone iodine plus bepanthenol for patients with moderate burns (TBSA<15%)
Study objectives	Moist exposed burn ointment (MEBO) substantially reduces the time of wound healing. Further reading: http://www.ncbi.nlm.nih.gov/pubmed/20121563
Ethics approval(s)	Scientific Committee of General Regional Hospital of Athens, Dr. Georgios Papastratis approved on the 1st of February 200 (ref: 199/2000)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	05/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	214
Total final enrolment	211
Key inclusion criteria	1. Total Burns Surface Area (TBSA) <15%. 2. Thermal burns 3. No need of surgical operation 4. Either sex, aged 18-75
Key exclusion criteria	Systematic diseases (cancer and diabetes)
Date of first enrolment	05/01/2002
Date of final enrolment	05/01/2006

Locations

Countries of recruitment

Greece

Study participating centre

Department of Plastic Surgery, Microsurgery and Burn Center, General State Hospital of Athens G. Gennimatas, 154 Mesogion Avenue Greece

Athens
11141
Greece

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011	18/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.