Clinical trial NCT02813213: Effectiveness Comparison of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Skin Ulcer
Burns
Keywords: skin transplantation
grafting skin
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2016-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of epithelialization
timeFrame: 14th day
Secondary outcomes:
measure: Histological study
timeFrame: 14th day
measure: Clinical percentage of epithelialization
timeFrame: 14th day
Other outcomes:
Locations:
city: Azcapotzalco
country: Mexico
facility: "La Raza" Medical Center. IMSS
state: Mexico City
Study officials:
References:
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