Wound Healing Disturbance of
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALADIPOSE TISSUE EXTRACT
Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
BIOLOGICALPLATELET-RICH PLASMA GEL
Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Sponsors
Tampere University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* donor site indication
Exclusion criteria
* immunosupressive states * terminal renal insufficiency * pregnancy * coagulation dyscrasias * active infection in donor site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Re-epithelization | 30 days | observational-digital photography with specialized custom-made software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Properties | 30 and 60 days | 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 |
| Oxygenated Hemoglobin | day 30 and 60 | 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. |
| Melanin Concentration in Wound | day 30 and 60 | 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CONTROL No intervention | 24 |
| 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 | 13 |
| 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 | 11 |
| Total | 48 |
Baseline characteristics
| Characteristic | CONTROL | ADIPOSE TISSUE EXTRACT | PLATELET-RICH PLASMA GEL | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 3 Participants | 9 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 10 Participants | 2 Participants | 25 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 16.82 | 56.07 years STANDARD_DEVIATION 16.57 | 62.45 years STANDARD_DEVIATION 17.23 | 59 years STANDARD_DEVIATION 16.82 |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 18 Participants | 10 Participants | 8 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 0 / 24 | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 24 | 0 / 13 | 0 / 11 |
Outcome results
Primary
Wound Re-epithelization
observational-digital photography with specialized custom-made software
Time frame: 30 days
Population: Measured as a whole per group as mean and standard deviation of group and not participant healing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CONTROL | Wound Re-epithelization | 12.34 days |
| ADIPOSE TISSUE EXTRACT | Wound Re-epithelization | 10.27 days |
| PLATELET-RICH PLASMA GEL | Wound Re-epithelization | 11.33 days |
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.
Time frame: day 30 and 60
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONTROL | Melanin Concentration in Wound | DAY 30 | 0.02 Arbitrary units | Standard Deviation 0.02 |
| CONTROL | Melanin Concentration in Wound | DAY 60 | 0.01 Arbitrary units | Standard Deviation 0.01 |
| ADIPOSE TISSUE EXTRACT | Melanin Concentration in Wound | DAY 60 | 0.02 Arbitrary units | Standard Deviation 0.04 |
| ADIPOSE TISSUE EXTRACT | Melanin Concentration in Wound | DAY 30 | 0.03 Arbitrary units | Standard Deviation 0.03 |
| PLATELET-RICH PLASMA GEL | Melanin Concentration in Wound | DAY 30 | 0.03 Arbitrary units | Standard Deviation 0.03 |
| PLATELET-RICH PLASMA GEL | Melanin Concentration in Wound | DAY 60 | 0.02 Arbitrary units | Standard Deviation 0.02 |
| CONTROL PRP | Melanin Concentration in Wound | DAY 30 | 0.03 Arbitrary units | Standard Deviation 0.03 |
| CONTROL PRP | Melanin Concentration in Wound | DAY 60 | 0.03 Arbitrary units | Standard Deviation 0.03 |
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.
Time frame: day 30 and 60
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONTROL | Oxygenated Hemoglobin | Day 30 | 0.36 Arbitrary units | Standard Deviation 0.18 |
| CONTROL | Oxygenated Hemoglobin | Day 60 | 0.18 Arbitrary units | Standard Deviation 0.3 |
| ADIPOSE TISSUE EXTRACT | Oxygenated Hemoglobin | Day 60 | 0.19 Arbitrary units | Standard Deviation 0.11 |
| ADIPOSE TISSUE EXTRACT | Oxygenated Hemoglobin | Day 30 | 0.20 Arbitrary units | Standard Deviation 0.22 |
| PLATELET-RICH PLASMA GEL | Oxygenated Hemoglobin | Day 30 | 0.24 Arbitrary units | Standard Deviation 0.31 |
| PLATELET-RICH PLASMA GEL | Oxygenated Hemoglobin | Day 60 | 0.09 Arbitrary units | Standard Deviation 0.17 |
| CONTROL PRP | Oxygenated Hemoglobin | Day 30 | 0.28 Arbitrary units | Standard Deviation 0.25 |
| CONTROL PRP | Oxygenated Hemoglobin | Day 60 | 0.01 Arbitrary units | Standard Deviation 0.16 |
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
Time frame: 30 and 60 days
Population: Modified Vancouver/Manchester scar scale at 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONTROL | Scar Properties | DAY 30 | 8.13 units on a scale | Standard Deviation 2.795 |
| CONTROL | Scar Properties | DAY 60 | 5.66 units on a scale | Standard Deviation 2.8 |
| ADIPOSE TISSUE EXTRACT | Scar Properties | DAY 30 | 4.86 units on a scale | Standard Deviation 2.13 |
| ADIPOSE TISSUE EXTRACT | Scar Properties | DAY 60 | 2.4 units on a scale | Standard Deviation 2.2 |
| PLATELET-RICH PLASMA GEL | Scar Properties | DAY 60 | 3.23 units on a scale | Standard Deviation 2.4 |
| PLATELET-RICH PLASMA GEL | Scar Properties | DAY 30 | 6.46 units on a scale | Standard Deviation 2.53 |
| CONTROL PRP | Scar Properties | DAY 30 | 6.85 units on a scale | Standard Deviation 2.23 |
| CONTROL PRP | Scar Properties | DAY 60 | 5.69 units on a scale | Standard Deviation 2.2 |