Comparing oil based ointment versus standard practice for the treatment of moderate burns in Greece: A cost effectiveness evaluation
ISRCTN | ISRCTN74058791 |
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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
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 design | Prospective pragmatic randomised trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please contact Prof V. Carayanni [bilma@otenet.gr] to request a patient 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 | 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 study start date | 05/01/2002 |
Completion date | 05/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 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
11141
Greece
Sponsor information
Regional General Hospital of Athens Georgios Gennimatas (Greece)
Hospital/treatment centre
Hospital/treatment centre
c/o I. Ioannovits
Department of Plastic Surgery
Microsurgery and Burn Center
154 Mesogion Avenue Greece
Athens
11141
Greece
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.