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
Secondary identifying numbers N/A
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

Study designProspective pragmatic randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact Prof V. Carayanni [bilma@otenet.gr] to request a patient information sheet
Scientific titleMoist exposed burn ointment versus povidone iodine plus bepanthenol for patients with moderate burns (TBSA<15%)
Study objectivesMoist 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) studiedBurns
InterventionPatients 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date05/01/2002
Completion date05/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants214
Total final enrolment211
Key inclusion criteria1. Total Burns Surface Area (TBSA) <15%.
2. Thermal burns
3. No need of surgical operation
4. Either sex, aged 18-75
Key exclusion criteriaSystematic diseases (cancer and diabetes)
Date of first enrolment05/01/2002
Date of final enrolment05/01/2006

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

Sponsor information

Regional General Hospital of Athens “Georgios Gennimatas” (Greece)
Hospital/treatment centre

c/o I. Ioannovits
Department of Plastic Surgery
Microsurgery and Burn Center
154 – Mesogion Avenue Greece
Athens
11141
Greece

ROR logo "ROR" https://ror.org/00zq17821

Funders

Funder type

Hospital/treatment centre

Regional General Hospital of Athens “Georgios Gennimatas” (Greece) - Department of Plastic Surgery, Microsurgery and Burn Center (equipment, stock medicines [except MEBO], and personnel

No information available

MEBO International Group Company (MEBO medicines) (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.