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

Effectiveness Comparison Between the Use of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts in Cutaneous Defects: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Skin Ulcer
• Intervention / Treatment: Procedure: Standard skin graft; Procedure: Skin micro Grafts

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alejandro Cruz, MD; Phone Number: 5534242197; Email: alejandrocruzsegura@hotmail.com
• Study Contact Backup: Name: Claudia Ramos; Phone Number: 23190 (52) 57245900

Study Locations

• Mexico
  • Mexico City
    • Azcapotzalco, Mexico City, Mexico, 02990
      • Recruiting
      • "La Raza" Medical Center. IMSS
      • Contact: Claudia Ramos; Phone Number: 23190 (52) 57245900
      • Contact: Arturo Jaquez, MD; Phone Number: 55 85359927
      • Principal Investigator: Alejandro Cruz, MD
      • Sub-Investigator: Arturo Jaquez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Standard skin graft; Standard split thickness (0.3-0.5mm) skin graft; Other Names: skin grafting; split thickness skin graft; skin grafts; medium split thickness skin graft
Experimental: Skin micro graft; 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; 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); Other Names: Xpansion micro auto grafting system; 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

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico

Publications and helpful links

General Publications

• Chern PL, Baum CL, Arpey CJ. Biologic dressings: current applications and limitations in dermatologic surgery. Dermatol Surg. 2009 Jun;35(6):891-906. doi: 10.1111/j.1524-4725.2009.01153.x. Epub 2009 Apr 6.
• MEEK CP. Successful microdermagrafting using the Meek-Wall microdermatome. Am J Surg. 1958 Oct;96(4):557-8. doi: 10.1016/0002-9610(58)90975-9. No abstract available.
• MEEK CP. Extensive severe burn treated with enzymatic debridement and microdermagrafting: case report. Am Surg. 1963 Jan;29:61-4. No abstract available.
• TANNER JC Jr, VANDEPUT J, OLLEY JF. THE MESH SKIN GRAFT. Plast Reconstr Surg. 1964 Sep;34:287-92. No abstract available.
• Green H, Rheinwald JG, Sun TT. Properties of an epithelial cell type in culture: the epidermal keratinocyte and its dependence on products of the fibroblast. Prog Clin Biol Res. 1977;17:493-500.
• Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell. 1975 Nov;6(3):331-43. doi: 10.1016/s0092-8674(75)80001-8.
• Munster AM. Use of cultured epidermal autograft in ten patients. J Burn Care Rehabil. 1992 Jan-Feb;13(1):124-6. doi: 10.1097/00004630-199201000-00028.
• Wood FM, Stoner M. Implication of basement membrane development on the underlying scar in partial-thickness burn injury. Burns. 1996 Sep;22(6):459-62. doi: 10.1016/0305-4179(95)00178-6.
• Chester DL, Balderson DS, Papini RP. A review of keratinocyte delivery to the wound bed. J Burn Care Rehabil. 2004 May-Jun;25(3):266-75. doi: 10.1097/01.bcr.0000124749.85552.cd.
• Lumenta DB, Kamolz LP, Frey M. Adult burn patients with more than 60% TBSA involved-Meek and other techniques to overcome restricted skin harvest availability--the Viennese Concept. J Burn Care Res. 2009 Mar-Apr;30(2):231-42. doi: 10.1097/BCR.0b013e318198a2d6.
• Svensjo T, Pomahac B, Yao F, Slama J, Wasif N, Eriksson E. Autologous skin transplantation: comparison of minced skin to other techniques. J Surg Res. 2002 Mar;103(1):19-29. doi: 10.1006/jsre.2001.6331.
• Hackl F, Bergmann J, Granter SR, Koyama T, Kiwanuka E, Zuhaili B, Pomahac B, Caterson EJ, Junker JPE, Eriksson E. Epidermal regeneration by micrograft transplantation with immediate 100-fold expansion. Plast Reconstr Surg. 2012 Mar;129(3):443e-452e. doi: 10.1097/PRS.0b013e318241289c.

Helpful Links

• Mincing device, Xpansion Micrografting System

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: skin transplantation; grafting skin
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer
• Other Study ID Numbers: R-2013-3501-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Only some data will be shared (age, gender, diagnosis, area defect and epithelialization ratio). Photos will be shared only if the patients give their consent.