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

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ClinicalTrials.gov Identifier: NCT02813213
Recruitment Status : Unknown
Verified January 2018 by Alejandro Cruz Segura, Coordinación de Investigación en Salud, Mexico.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Alejandro Cruz Segura, 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.


Condition or disease Intervention/treatment Phase
Skin Ulcer Burns Procedure: Skin micro Grafts Procedure: Standard skin graft Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

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:
  • split thickness skin graft
  • skin grafting
  • 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




Primary Outcome Measures :
  1. Percentage of epithelialization [ Time Frame: 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 :
  1. Histological study [ Time Frame: 14th day ]
    Study of the histological characteristics of the skin under microscope

  2. Clinical percentage of epithelialization [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813213


Contacts
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Contact: Alejandro Cruz, MD 5534242197 alejandrocruzsegura@hotmail.com
Contact: Claudia Ramos (52) 57245900 ext 23190

Locations
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Mexico
"La Raza" Medical Center. IMSS Recruiting
Azcapotzalco, Mexico City, Mexico, 02990
Contact: Claudia Ramos    (52) 57245900 ext 23190      
Contact: Arturo Jaquez, MD    55 85359927      
Principal Investigator: Alejandro Cruz, MD         
Sub-Investigator: Arturo Jaquez, MD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Additional Information:
Publications of Results:

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Responsible Party: Alejandro Cruz Segura, MD, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02813213    
Other Study ID Numbers: R-2013-3501-8
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Alejandro Cruz Segura, Coordinación de Investigación en Salud, Mexico:
skin transplantation
grafting skin
Additional relevant MeSH terms:
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Skin Ulcer
Skin Diseases