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IRCT138902281605N9 IRCT 2010-06-12 Vice-chancellor for Research Evaluation of effect of amniotic membrane on split-thickness skin fixation in patient with extremities burns Evaluation of effect of amniotic membrane on split-thickness skin fixation in patient with extremities burns in ghotbeddin hospital 2008-10-01 anticipated 108 Complete https://irct.ir/trial/1041 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A skin graft. Intervention 1: 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. Intervention 2: Control :wounds are grafted with split thickness method by using stapler to fix.
public Ali Akbar Mohammadi
Fakhrabad Street, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 1821 9638 mohamadiaa@sums.ac.ir Shiraz University of Medical Sciences scientific Ali Akbar Mohammadi
Shiraz Burn Research Center, Ghotbeddin Hospital, Fakhrabad St.
Shiraz Iran (Islamic Republic of) +98 71 1821 9638 mohamadiaa@sums.ac.ir Burn reaserch center, Shiraz University of Medical Sciences, Iran (Islamic Republic of) 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 13 years 60 years Male T86.8 Failure and rejection of other transplanted organs and tissues Treatment - Surgery Treatment - Surgery 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. Control :wounds are grafted with split thickness method by using stapler to fix Percentage of grafttake. Timepoint: 2 weeks after operation. Method of measurement: determination of graftake by meter. Graftake time. Timepoint: every other day. Method of measurement: time between operation and graftake. Vice-chancellor for Research Approved 2010-03-10 Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd. Shiraz Iran (Islamic Republic of)