Efficacy of medical honey usage for fixation of split thickness skin grafts and comparison with common method in deep second degree and third degree burn patients
The goal of this study is to assess the effect of medical honey in skin grafting of burn patients in comparison to regular methods. In the study period, 60 patients with deep second and third degree burns will be studied. Skin grafting will be conducted to the entire patients. The patients will be divided into two groups randomly and single blinded. The first group will receive medical honey; while the second group will receive routine care only. The effect of the use of medical honey will be assessed by the rate of infection, loss of graft, shrinkage of graft, postoperative pain and hospitalization period. For the study purpose, after adequate debridment of the burn wound, a layer of medical honey will be placed on the wound bed in the first group. Then the graft will be placed followed by surgical dressing. Patients with burns on genitalia and fingers will be excluded. In addition, patients with a history of a documented medical illness such as diabetes mellitus, heart failure, pulmonary disease and cirrhosis will be excluded from the study. The patients will be visited on the fifth day after the operation and dressing of wounds will be opened and assessed. Thereafter, the entire patients will be visited every two days. Follow-up visits will also be done one-month and two-month after the operation as outpatient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111188122N1
Registration date:2012-04-06, 1391/01/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-06, 1391/01/18
Registrant information
Name
Sohrab Moradi Bajestani
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
dr.moradi@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Sina Hospital, Tabriz
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of medical honey usage for fixation of split thickness skin grafts and comparison with common method in deep second degree and third degree burn patients
Public title
Efficacy of medical honey in fixation of skin grafts in burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Deep second degree and third degree burn
Exclusion criteria : History of medical conditions such as diabetes, respiratory and heart failure and cirrhosis; Honey sensitivity; Head and neck, digits and genitalia burn
Age
From 5 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Postal code
Approval date
2012-01-03, 1390/10/13
Ethics committee reference number
5/4/8113
Health conditions studied
1
Description of health condition studied
second degree and third degree burn of trunk and limbs except digits and genitalia
ICD-10 code
T21.2; T21
ICD-10 code description
Burn of second degree of trunk; Burn of third degree of trunk; Burn of second degree of shoulder and upper limb, except wrist and hand; Burn of third degree of shoulder and upper limb, except wrist and hand; Burn of second degree of hip and lower limb, ex
Primary outcomes
1
Description
Rate of graft shrinkage
Timepoint
Fifth day after the operation then every two days until six days and then in first and second months
Method of measurement
The percentage area ratio - Ruler
2
Description
Wound infection rate
Timepoint
Fifth day after the operation then every two days until six days and then in first and second months
Method of measurement
Purulent discharg and inflammation - Physical examination
3
Description
Rate of loss of graft
Timepoint
Fifth day after the operation then every two days until six days and then in first and second months
Method of measurement
Graft necrosis - Physical examination
4
Description
Length of hospital stay
Timepoint
During hospitalization
Method of measurement
Day - Calendar
5
Description
Wound pain rate
Timepoint
Every two days after operation until discharge
Method of measurement
Visual analog pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention in case group:
Skin graft fixation by medical honey (MEDIHONEY)
Category
Treatment - Surgery
2
Description
Intervention in control group:
Skin graft fixation by usual method (with sutures)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hemat Maghsoudi, MD
Street address
Sina Hospital, Azadi Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hemat Maghsoudi, MD
Street address
Sina Hospital, Azadi Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Hemat Maghsoudi, MD
Position
Professor of General Surgery
Other areas of specialty/work
Street address
Sina Hospital, Azadi Avenue
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
+98 41 1541 2101
Email
maghsoudih@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Hemat Maghsoudi, MD
Position
Professor of General Surgery
Other areas of specialty/work
Street address
Sina Hospital, Azadi Avenue
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
+98 41 1541 2101
Email
maghsoudih@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Sohrab Moradi Bajestani, MD
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
dr.moradi@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)