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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02813213
Study type Interventional
Source Coordinación de Investigación en Salud, Mexico
Contact Alejandro Cruz, MD
Phone 5534242197
Email alejandrocruzsegura@hotmail.com
Status Recruiting
Phase Phase 4
Start date June 2016
Completion date September 2018

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