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

Primary Purpose

Skin Ulcer, Burns

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Skin micro Grafts
Standard skin graft
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Ulcer focused on measuring skin transplantation, grafting skin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "La Raza" Medical Center. IMSSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard skin graft

Skin micro graft

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Histological study
Study of the histological characteristics of the skin under microscope
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.

Full Information

First Posted
June 21, 2016
Last Updated
January 25, 2018
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02813213
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Ulcer, Burns
Keywords
skin transplantation, grafting skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard skin graft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Skin micro graft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin micro Grafts
Other Intervention Name(s)
Xpansion micro auto grafting system, micro grafts
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard skin graft
Other Intervention Name(s)
split thickness skin graft, skin grafting, skin grafts, medium split thickness skin graft
Intervention Description
Standard split thickness (0.3-0.5mm) skin graft
Primary Outcome Measure Information:
Title
Percentage of epithelialization
Description
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
Time Frame
14th day
Secondary Outcome Measure Information:
Title
Histological study
Description
Study of the histological characteristics of the skin under microscope
Time Frame
14th day
Title
Clinical percentage of epithelialization
Description
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.
Time Frame
14th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Cruz, MD
Phone
5534242197
Email
alejandrocruzsegura@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Ramos
Phone
(52) 57245900
Ext
23190
Facility Information:
Facility Name
"La Raza" Medical Center. IMSS
City
Azcapotzalco
State/Province
Mexico City
ZIP/Postal Code
02990
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Ramos
Phone
(52) 57245900
Ext
23190
First Name & Middle Initial & Last Name & Degree
Arturo Jaquez, MD
Phone
55 85359927
First Name & Middle Initial & Last Name & Degree
Alejandro Cruz, MD
First Name & Middle Initial & Last Name & Degree
Arturo Jaquez, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19397669
Citation
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.
Results Reference
result
PubMed Identifier
13571547
Citation
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.
Results Reference
result
PubMed Identifier
13934413
Citation
MEEK CP. Extensive severe burn treated with enzymatic debridement and microdermagrafting: case report. Am Surg. 1963 Jan;29:61-4. No abstract available.
Results Reference
result
PubMed Identifier
14209177
Citation
TANNER JC Jr, VANDEPUT J, OLLEY JF. THE MESH SKIN GRAFT. Plast Reconstr Surg. 1964 Sep;34:287-92. No abstract available.
Results Reference
result
PubMed Identifier
928463
Citation
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.
Results Reference
result
PubMed Identifier
1052771
Citation
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.
Results Reference
result
PubMed Identifier
1572841
Citation
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.
Results Reference
result
PubMed Identifier
8884006
Citation
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.
Results Reference
result
PubMed Identifier
15273468
Citation
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.
Results Reference
result
PubMed Identifier
19165111
Citation
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.
Results Reference
result
PubMed Identifier
11855913
Citation
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.
Results Reference
result
PubMed Identifier
22373992
Citation
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.
Results Reference
result
Links:
URL
http://www.steadmed.com
Description
Mincing device, Xpansion Micrografting System

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

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