Burns Clinical Trial
Official title:
Effectiveness Comparison Between the Use of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts in Cutaneous Defects: A Randomized Controlled Clinical Trial
This is a double-blind randomized controlled clinical trial, that compares the percentage of
epithelialization of skin defects using the conventional meshed split thickness skin grafts
vs skin micro grafts.
Two techniques will be applied in the same patient. The skin defect will be divided in two
parts, and with a randomized method each half of this defect will be assigned to one of the
two techniques.
Split thickness skin graft is the standard technique in skin defects reconstruction.
The etiology of this problem is diverse (burns, infections, trauma, cancer) however, many
times the availability of donor areas are insufficient and morbidity and complications that
may arise make prohibitive the use of this technique in many situations.
Skin micro grafts technique consists in using a very small part of skin (0.8x 0.8 mm) and
keratinocyte growth-factor solution that allows a 1:50- 1:100 skin expansion. It has many
advantages: it can be performed with local anesthesia and donor area is tiny.
The study consists in using the conventional and the new technique in the same patient. The
skin defect will be divided in two parts, and with a randomized method each half of this
defect will be assigned to one of the two different techniques. The result variable will be
the "percentage of epithelialization" and will be compared in the two halves. This variable
will be measured at day 14 using clinical and image software methods. The patient and the
investigator that record the outcome variable will be blinded to the type of technique.
The investigators will take skin biopsies of two halves and will perform pathology studies.
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