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Trial Outcomes & Findings for Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing (NCT NCT02799290)

NCT ID: NCT02799290

Last Updated: 2021-01-07

Results Overview

observational-digital photography with specialized custom-made software

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

30 days

Results posted on

2021-01-07

Participant Flow

Unit of analysis: donor site

Participant milestones

Participant milestones
Measure
CONTROL
No treatment
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
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
Overall Study
STARTED
24 28
13 15
11 13
Overall Study
COMPLETED
24 28
13 15
11 13
Overall Study
NOT COMPLETED
0 0
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CONTROL
n=24 Participants
No intervention
ADIPOSE TISSUE EXTRACT
n=13 Participants
Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GEL
n=11 Participants
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Total
n=48 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=5 Participants
10 Participants
n=7 Participants
2 Participants
n=5 Participants
25 Participants
n=4 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
23 Participants
n=4 Participants
Age, Continuous
59 years
STANDARD_DEVIATION 16.82 • n=5 Participants
56.07 years
STANDARD_DEVIATION 16.57 • n=7 Participants
62.45 years
STANDARD_DEVIATION 17.23 • n=5 Participants
59 years
STANDARD_DEVIATION 16.82 • n=4 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
12 Participants
n=4 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
10 Participants
n=7 Participants
8 Participants
n=5 Participants
36 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Measured as a whole per group as mean and standard deviation of group and not participant healing.

observational-digital photography with specialized custom-made software

Outcome measures

Outcome measures
Measure
CONTROL
n=24 Participants
No treatment
ADIPOSE TISSUE EXTRACT
n=13 Participants
Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GEL
n=11 Participants
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
CONTROL PRP
No treatment
Wound Re-epithelization
12.34 days
10.27 days
11.33 days
—

SECONDARY outcome

Timeframe: 30 and 60 days

Population: Modified Vancouver/Manchester scar scale at 30 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

Outcome measures

Outcome measures
Measure
CONTROL
n=13 Participants
No treatment
ADIPOSE TISSUE EXTRACT
n=13 Participants
Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GEL
n=11 Participants
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
CONTROL PRP
n=11 Participants
No treatment
Scar Properties
DAY 30
8.13 units on a scale
Standard Deviation 2.795
4.86 units on a scale
Standard Deviation 2.13
6.46 units on a scale
Standard Deviation 2.53
6.85 units on a scale
Standard Deviation 2.23
Scar Properties
DAY 60
5.66 units on a scale
Standard Deviation 2.8
2.4 units on a scale
Standard Deviation 2.2
3.23 units on a scale
Standard Deviation 2.4
5.69 units on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CONTROL
n=13 Participants
No treatment
ADIPOSE TISSUE EXTRACT
n=13 Participants
Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GEL
n=11 Participants
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
CONTROL PRP
n=11 Participants
No treatment
Oxygenated Hemoglobin
Day 30
0.36 Arbitrary units
Standard Deviation 0.18
0.20 Arbitrary units
Standard Deviation 0.22
0.24 Arbitrary units
Standard Deviation 0.31
0.28 Arbitrary units
Standard Deviation 0.25
Oxygenated Hemoglobin
Day 60
0.18 Arbitrary units
Standard Deviation 0.30
0.19 Arbitrary units
Standard Deviation 0.11
0.09 Arbitrary units
Standard Deviation 0.17
0.01 Arbitrary units
Standard Deviation 0.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CONTROL
n=13 Participants
No treatment
ADIPOSE TISSUE EXTRACT
n=13 Participants
Adipose Tissue extract application ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GEL
n=11 Participants
PLATELET RICH PLASMA GEL APPLICATION PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
CONTROL PRP
n=11 Participants
No treatment
Melanin Concentration in Wound
DAY 30
0.02 Arbitrary units
Standard Deviation 0.02
0.03 Arbitrary units
Standard Deviation 0.03
0.03 Arbitrary units
Standard Deviation 0.03
0.03 Arbitrary units
Standard Deviation 0.03
Melanin Concentration in Wound
DAY 60
0.01 Arbitrary units
Standard Deviation 0.01
0.02 Arbitrary units
Standard Deviation 0.04
0.02 Arbitrary units
Standard Deviation 0.02
0.03 Arbitrary units
Standard Deviation 0.03

Adverse Events

CONTROL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ADIPOSE TISSUE EXTRACT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PLATELET-RICH PLASMA GEL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ilkka Kaartinen

Tampere University Hospital

Phone: 505687096

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place