Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Adipose Tissue Extract and Platelet-rich Plasma on Split-thickness Donor Site Wound Healing. A Comparative Study

Conditions
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Wound Healing Disturbance of

Intervention / Treatment
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* Biological: ADIPOSE TISSUE EXTRACT
* Biological: PLATELET-RICH PLASMA GEL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: donor site indication Exclusion Criteria: immunosupressive states terminal renal insufficiency pregnancy coagulation dyscrasias active infection in donor site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>No intervention | |
| Experimental: ADIPOSE TISSUE EXTRACT<br>Adipose Tissue extract application | Biological: ADIPOSE TISSUE EXTRACT<br>* Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration<br>* Other names: ATE;|
| Experimental: PLATELET-RICH PLASMA GEL<br>PLATELET RICH PLASMA GEL APPLICATION | Biological: PLATELET-RICH PLASMA GEL<br>* Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions<br>* Other names: PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Re-epithelization | observational-digital photography with specialized custom-made software | 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |