Fifty four patients (108 limbs) with deep 2nd and 3rd degree burns included in a prospective clinical trial. All patients needed split-thickness skin graft for burn wound coverage. We selected the patients who had symmetric burns on two (upper or lower) extremities, and then the extremities were randomly assigned into two groups. In one limb, the skin graft traditionally fixed with skin staples (control group) but in the other limb the skin graft fixed with amniotic membrane (amnion group). In the amnion group, the graft was inserted on the wound bed, the amniotic membrane was wrapped around the grafted extremity and dressing was applied. The membrane adheres to itself when wrapped around the extremity and there is no need to any stitch or staple. On the 5th post-op day, in both groups, the dressings were removed, the wound was irrigated with normal saline, the skin graft was covered with sterile Vaseline gauze and again dressing was applied. This changing dressing continued every other day till the complete graft take was achieved. The duration and success rate of complete graft take were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902281605N9
Registration date:2010-06-12, 1389/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice chancellor for Research
Expected recruitment start date
2008-10-01, 1387/07/10
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of amniotic membrane on split-thickness skin fixation in patient with extremities burns in ghotbeddin hospital
Public title
Evaluation of effect of amniotic membrane on split-thickness skin fixation in patient with extremities burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Deep 2nd and 3rd degree burns; symmetric burns on two (upper or lower) extremities, candidates for split-thickness skin graft
Exclusion criteria: age more than 60, history of cardiac disease, renal failure, diabetes mellitus, any other severe underlying metabolic disorder
Age
From 13 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Amniotic membranes were retrieved from elective cesarean sections of mothers without any sexually transmitted disease, endometritis, premature rupture of the membranes or meconium stained amniotic fluid. The amnion is carefully separated from chorion and placenta and washed thoroughly with normal saline until a whitish, smooth, transparent layer remains, which is then stored in normal saline-gentamicin solution at 4°С. If HIV, HBS, HCV and VDRL tests are negative for both mother and umbilical cord, the amniotic membrane will be used. Routine cultures are obtained from stored membranes to rule out bacterial contamination
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Postal code
Approval date
2010-03-10, 1388/12/19
Ethics committee reference number
CT-88-01-01-1634
Health conditions studied
1
Description of health condition studied
skin graft
ICD-10 code
T86.8
ICD-10 code description
Failure and rejection of other transplanted organs and tissues
Primary outcomes
1
Description
percentage of grafttake
Timepoint
2 weeks after operation
Method of measurement
determination of graftake by meter
2
Description
graftake time
Timepoint
every other day
Method of measurement
time between operation and graftake
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:In the amnion group, the graft was inserted on the wound bed, the amniotic membrane was wrapped around the grafted extremity and dressing was applied. The membrane adheres to itself when wrapped around the extremity and there is no need to any stitch or staple. On the 5th post-op day, in both groups, the dressings were removed, the wound was irrigated with normal saline, the skin graft was covered with sterile Vaseline gauze and again dressing was applied. This changing dressing continued every other day till the complete graft take was achieved.
Category
Treatment - Surgery
2
Description
Control :wounds are grafted with split thickness method by using stapler to fix
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn reaserch center;Ghotb-eddin Burn Center
Full name of responsible person
Ali Akbar Mohammadi
Street address
Burn reaserch center, Fakhrabad Street, Shiraz .
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Burn reaserch center, Shiraz University of Medical Sciences,
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Shiraz Burn Research Center, Ghotbeddin Hospital, Fakhrabad St.
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Burn Reaserch Center
Full name of responsible person
Masoomeh Kherad
Position
manager of Shiraz Burn Reaserch Center/Bachelor of nursing
Other areas of specialty/work
Street address
Fakhrabad St., Ghotbeddin Hospital, Shiraz Burn Reaserch Center
City
Shiraz
Postal code
Phone
+98 71 1820 8880
Fax
Email
burnres1@sums.ac.ir
Web page address
www.burnres.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)