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

Phase 4

• Conditions: Burns; Skin Ulcer
• Interventions: Procedure: Standard skin graft; Procedure: Skin micro Grafts

• Registration Number: NCT02813213
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26
• Primary Completion: 2018-08
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard skin graft	Standard skin graft	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.
Skin micro graft	Skin micro Grafts	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Histological study	14th day	Study of the histological characteristics of the skin under microscope

Trial Locations

Locations (1)

"La Raza" Medical Center. IMSS; 🇲🇽 Azcapotzalco, Mexico City, Mexico