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Completed

NCT Number: NCT02799290

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

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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Key information

Conditions

Wound Healing Disturbance of

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jenny Lopez, Ilkka Kaartinen

Tampere, Pirkanmaa, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • donor site indication

Exclusion criteria

  • immunosupressive states
  • terminal renal insufficiency
  • pregnancy
  • coagulation dyscrasias
  • active infection in donor site

Treatment and study plan

ADIPOSE TISSUE EXTRACT

Biological

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

Other names: ATE

PLATELET-RICH PLASMA GEL

Biological

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

Other names: PRP

Primary outcomes

  1. Wound Re-epithelization

    Time frame: 30 days

    observational-digital photography with specialized custom-made software

Secondary outcomes

  1. Scar Properties

    Time frame: 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

  2. Oxygenated Hemoglobin

    Time frame: 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.

  3. Melanin Concentration in Wound

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2016
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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