Effectiveness Comparison of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts

Study Overview
=================
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.

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

Conditions
-----------------
Skin Ulcer, Burns

Intervention / Treatment
-----------------
* Procedure: Skin micro Grafts
* Procedure: Standard skin graft


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard skin graft<br>This group is comprised of patients' wound halves that will receive meshed (1:3) split thickness skin graft (0.3-0.5mm thickness). This half will be covered with a standard tie over dressing. The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day. | Procedure: Standard skin graft<br>* Standard split thickness (0.3-0.5mm) skin graft<br>* Other names: medium split thickness skin graft;|
| Experimental: Skin micro graft<br>This group is comprised of the patients' wound halves that will receive skin micro grafts. To obtain this grafts the investigators will use Xpansion micro-autografting system. They will use 0.8 x 0.8 mm skin grafts with a graft to graft distance of 4mm (1:50 expansion).This half will be covered with a special hydrogel dressing with keratinocyte growth factor (Epilife medium with calcium) 1.5ml for each 14 square centimeters of the wound. This half will be covered with a wet adhesive foam dressing and then it will be covered up with a non-adherent interface dressing (tegaderm). The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day. Each time of dressing change only the non-adherent interface dressing will be removed, and the area will be bathed with keratinocyte growth factor solution. | Procedure: Skin micro Grafts<br>* 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)<br>* Other names: micro grafts;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of epithelialization | 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 | 14th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological study | Study of the histological characteristics of the skin under microscope | 14th day | 
| Clinical percentage of epithelialization | 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. | 14th day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin transplantation, grafting skin