Burns, Skin Ulcer
Conditions
Keywords
skin transplantation, grafting skin
Brief 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.
Detailed 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.
Interventions
PROCEDURESkin micro Grafts
0.8 x 0.8 skin micro graft with graft to graft distance of 4 cm (1:50 expansion) bathed with keratinocyte growth factor solution ( 1.5 ml for each 14 square centimeters of wound)
PROCEDUREStandard skin graft
Standard split thickness (0.3-0.5mm) skin graft
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Non complicated wounds (no infection, no cancer) * Wound area: 20 x 20 cms or less * Located in diverse anatomical regions (except axillar, groin, genital, sole, scalp and flexion or extension areas)
Exclusion criteria
* High cardiovascular risk * Patients with indication of a different technique
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of epithelialization | 14th day | It will be measured with imaging software (comparing color density) in order to calculate the percentage of epithelialization at day 14 compared with the initial wound area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological study | 14th day | Study of the histological characteristics of the skin under microscope |
| Clinical percentage of epithelialization | 14th day | It will be measured with the irregular patterns technique that uses different sizes of geometric patterns in order to calculate the area of a irregular surface. Epithelialization will be compared at day 14 compared with the initial wound area. |
Countries
Mexico
Contacts
Primary ContactAlejandro Cruz, MD
Backup ContactClaudia Ramos
Outcome results
None listed