Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
Primary Purpose
Wound Healing Disturbance of
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
ADIPOSE TISSUE EXTRACT
PLATELET-RICH PLASMA GEL
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Healing Disturbance of
Eligibility Criteria
Inclusion Criteria:
- donor site indication
Exclusion Criteria:
- immunosupressive states
- terminal renal insufficiency
- pregnancy
- coagulation dyscrasias
- active infection in donor site
Sites / Locations
- Jenny Lopez, Ilkka Kaartinen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
CONTROL
ADIPOSE TISSUE EXTRACT
PLATELET-RICH PLASMA GEL
Arm Description
No intervention
Adipose Tissue extract application
PLATELET RICH PLASMA GEL APPLICATION
Outcomes
Primary Outcome Measures
Wound Re-epithelization
observational-digital photography with specialized custom-made software
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02799290
Brief Title
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
Official Title
The Effect of Adipose Tissue Extract and Platelet-rich Plasma on Split-thickness Donor Site Wound Healing. A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing Disturbance of
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
ADIPOSE TISSUE EXTRACT
Arm Type
Experimental
Arm Description
Adipose Tissue extract application
Arm Title
PLATELET-RICH PLASMA GEL
Arm Type
Experimental
Arm Description
PLATELET RICH PLASMA GEL APPLICATION
Intervention Type
Biological
Intervention Name(s)
ADIPOSE TISSUE EXTRACT
Other Intervention Name(s)
ATE
Intervention Description
Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
Intervention Type
Biological
Intervention Name(s)
PLATELET-RICH PLASMA GEL
Other Intervention Name(s)
PRP
Intervention Description
Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Primary Outcome Measure Information:
Title
Wound Re-epithelization
Description
observational-digital photography with specialized custom-made software
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Scar Properties
Description
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
Title
Oxygenated Hemoglobin
Description
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
Title
Melanin Concentration in Wound
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
donor site indication
Exclusion Criteria:
immunosupressive states
terminal renal insufficiency
pregnancy
coagulation dyscrasias
active infection in donor site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Ylikomi, PhD
Organizational Affiliation
Tampere University
Official's Role
Study Director
Facility Information:
Facility Name
Jenny Lopez, Ilkka Kaartinen
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
If required, individual data can be shown
Citations:
PubMed Identifier
21902602
Citation
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.
Results Reference
result
PubMed Identifier
22738319
Citation
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.
Results Reference
result
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Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
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