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

NCT ID: NCT02799290

Last Updated: 2021-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Wound Healing Disturbance of

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CONTROL

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

ADIPOSE TISSUE EXTRACT

Adipose Tissue extract application

Group Type EXPERIMENTAL

ADIPOSE TISSUE EXTRACT

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

PLATELET-RICH PLASMA GEL

Intervention Type BIOLOGICAL

Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions

Interventions

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ADIPOSE TISSUE EXTRACT

Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration

Intervention Type BIOLOGICAL

PLATELET-RICH PLASMA GEL

Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions

Intervention Type BIOLOGICAL

Other Intervention Names

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ATE PRP

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role lead

Responsible Party

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Jenny Lopez

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timo Ylikomi, PhD

Role: STUDY_DIRECTOR

Tampere University

Locations

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Jenny Lopez, Ilkka Kaartinen

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type RESULT
PMID: 21902602 (View on PubMed)

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.

Reference Type RESULT
PMID: 22738319 (View on PubMed)

Other Identifiers

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R15034

Identifier Type: -

Identifier Source: org_study_id

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