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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJanuary 26, 2018
January 1, 2018
2.2 years
June 21, 2016
January 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Histological study
14th day
Clinical percentage of epithelialization
14th day
Study Arms (2)
Standard skin graft
ACTIVE COMPARATORThis 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
EXPERIMENTALThis 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.
Interventions
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)
Standard split thickness (0.3-0.5mm) skin graft
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- High cardiovascular risk
- Patients with indication of a different technique
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"La Raza" Medical Center. IMSS
Azcapotzalco, Mexico City, 02990, Mexico
Related Publications (12)
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.
PMID: 19397669RESULTMEEK 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.
PMID: 13571547RESULTMEEK CP. Extensive severe burn treated with enzymatic debridement and microdermagrafting: case report. Am Surg. 1963 Jan;29:61-4. No abstract available.
PMID: 13934413RESULTTANNER JC Jr, VANDEPUT J, OLLEY JF. THE MESH SKIN GRAFT. Plast Reconstr Surg. 1964 Sep;34:287-92. No abstract available.
PMID: 14209177RESULTGreen 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.
PMID: 928463RESULTRheinwald 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.
PMID: 1052771RESULTMunster 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.
PMID: 1572841RESULTWood 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.
PMID: 8884006RESULTChester 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.
PMID: 15273468RESULTLumenta 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.
PMID: 19165111RESULTSvensjo 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.
PMID: 11855913RESULTHackl 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.
PMID: 22373992RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 24, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2018
Study Completion
September 1, 2018
Last Updated
January 26, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
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.