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

Wound Healing Disturbance of Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799290
• Other study ID #: R15034
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2020
• Source: Tampere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• donor site indication

Exclusion Criteria:

• immunosupressive states

• terminal renal insufficiency

• pregnancy

• coagulation dyscrasias

• active infection in donor site

Related Conditions & MeSH terms

• Wound Healing Disturbance of
• Wounds and Injuries

Intervention

Biological:
• ADIPOSE TISSUE EXTRACT
Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
• PLATELET-RICH PLASMA GEL
Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions

Locations

Country	Name	City	State
Finland	Jenny Lopez, Ilkka Kaartinen	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Sarkanen JR, Kaila V, Mannerström B, Räty 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Re-epithelization	observational-digital photography with specialized custom-made software	30 days
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	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.	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.	day 30 and 60