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Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate procedure. We sought to compare the effect of ATE with another known source, platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.
The investigators enrolled 24 participants with an indication for skin graft. Two or more split-thickness grafts are harvested per patient, one serving as control and the other as experimental. The experimental sites were covered with either autologous PRP gel or ATE prepared in the OR, which was selected in an unblinded manner due to surgical theater convenience. However, donor sites were randomized through a computer generator. Covered with a semiocclusive film, wounds were separated and followed up on days 3,5,7,10,14 for wound healing and 30 and 60 for scar evaluation. Digital photography and specto-photocutometry was employed to know the hemoglobin and melanin content of the wounds, and custom-made software was used to calculate the percentage of wound re-epithelialization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | No Intervention | No intervention | |
| ADIPOSE TISSUE EXTRACT | Experimental | Adipose Tissue extract application |
|
| PLATELET-RICH PLASMA GEL | Experimental | PLATELET RICH PLASMA GEL APPLICATION |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADIPOSE TISSUE EXTRACT | Biological | Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Re-epithelization | observational-digital photography with specialized custom-made software | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Properties | Vancouver Manchester modified scar scale Minimum value 0 maximum value 14 Higher scores mean worse outcome (Scale analyzes 5 wound characteristics in a numeric scale, where 0 is the best scar outcome and 14 the worst. These characteristics are wound: pigmentation, height, vascularity, contour, texture and brightness.) See scale below Vascularity Normal 0 Pink 1 Red 2 Purple 3 Pigmentation Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Height Flat 0 Depressed1 Elevated 2 Matte vs. shine Shine 0 Matte 1 Contour Forms part of the adjacent skin 0 Small indentation or invagination 1 Hypertrophic 2 Keloid 3 Texture Normal 0 Barely palpable 1 Rough 2 Indented 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timo Ylikomi, PhD | Tampere University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jenny Lopez, Ilkka Kaartinen | Tampere | Pirkanmaa | 33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21902602 | Result | Sarkanen JR, Kaila V, Mannerstrom B, Raty S, Kuokkanen H, Miettinen S, Ylikomi T. Human adipose tissue extract induces angiogenesis and adipogenesis in vitro. Tissue Eng Part A. 2012 Jan;18(1-2):17-25. doi: 10.1089/ten.TEA.2010.0712. Epub 2011 Oct 4. | |
| 22738319 | Result | Sarkanen JR, Ruusuvuori P, Kuokkanen H, Paavonen T, Ylikomi T. Bioactive acellular implant induces angiogenesis and adipogenesis and sustained soft tissue restoration in vivo. Tissue Eng Part A. 2012 Dec;18(23-24):2568-80. doi: 10.1089/ten.TEA.2011.0724. Epub 2012 Aug 17. |
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If required, individual data can be shown
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| ID | Title | Description |
|---|---|---|
| FG000 | CONTROL | No treatment |
| FG001 | ADIPOSE TISSUE EXTRACT | Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration |
| FG002 | PLATELET-RICH PLASMA GEL | PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Wound healing characteristics of donor sites in time
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| ID | Title | Description |
|---|---|---|
| BG000 | CONTROL | No intervention |
| BG001 | ADIPOSE TISSUE EXTRACT | Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Re-epithelization | observational-digital photography with specialized custom-made software | Measured as a whole per group as mean and standard deviation of group and not participant healing. | Posted | Number | days | 30 days |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CONTROL | No treatment | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilkka Kaartinen | Tampere University Hospital | 505687096 | ilkka.kaartinen@pshp.fi |
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|
| PLATELET-RICH PLASMA GEL | Biological | Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions |
|
|
| 30 and 60 days |
| Oxygenated Hemoglobin | Spectophotocutometry measurements with specialized digital camera and software analysis measured in estimated concentration changes (ECC). ECC is a ratio of light reflected hemoglobin chromofore on a special diode light camera. The ratio is between the scar and the adjacent normal skin and is an arbitrary scale previously published. From 0 to 1, where 1 are values closest to the adjacent healthy unscarred skin. | day 30 and 60 |
| Melanin Concentration in Wound | Melanin concentration measured by spectophotocutometry and analyzed by computer software and represented in estimated concentration changes (ECC), as explained above is an arbitrary ratio between the light absorbance between the scar and the adjacent healthy (unscarred skin) for the melanin chromofore. | day 30 and 60 |
| BG002 | PLATELET-RICH PLASMA GEL | PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| PLATELET-RICH PLASMA GEL |
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions |
|
|
| Secondary | Scar Properties | Vancouver Manchester modified scar scale Minimum value 0 maximum value 14 Higher scores mean worse outcome (Scale analyzes 5 wound characteristics in a numeric scale, where 0 is the best scar outcome and 14 the worst. These characteristics are wound: pigmentation, height, vascularity, contour, texture and brightness.) See scale below Vascularity Normal 0 Pink 1 Red 2 Purple 3 Pigmentation Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Height Flat 0 Depressed1 Elevated 2 Matte vs. shine Shine 0 Matte 1 Contour Forms part of the adjacent skin 0 Small indentation or invagination 1 Hypertrophic 2 Keloid 3 Texture Normal 0 Barely palpable 1 Rough 2 Indented 3 | Modified Vancouver/Manchester scar scale at 30 days | Posted | Mean | Standard Deviation | units on a scale | 30 and 60 days |
|
|
|
| Secondary | Oxygenated Hemoglobin | Spectophotocutometry measurements with specialized digital camera and software analysis measured in estimated concentration changes (ECC). ECC is a ratio of light reflected hemoglobin chromofore on a special diode light camera. The ratio is between the scar and the adjacent normal skin and is an arbitrary scale previously published. From 0 to 1, where 1 are values closest to the adjacent healthy unscarred skin. | Posted | Mean | Standard Deviation | Arbitrary units | day 30 and 60 |
|
|
|
| Secondary | Melanin Concentration in Wound | Melanin concentration measured by spectophotocutometry and analyzed by computer software and represented in estimated concentration changes (ECC), as explained above is an arbitrary ratio between the light absorbance between the scar and the adjacent healthy (unscarred skin) for the melanin chromofore. | Posted | Mean | Standard Deviation | Arbitrary units | day 30 and 60 |
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | ADIPOSE TISSUE EXTRACT | Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | PLATELET-RICH PLASMA GEL | PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions | 0 | 11 | 0 | 11 | 0 | 11 |
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| DAY 60 |
|
| Day 60 |
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| DAY 60 |
|