Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/10/2010
Date assigned
12/11/2010
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ioannis Ioannovits

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes