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

Phase 2

Completed

• Conditions: Wound Healing Disturbance of
• Interventions: Biological: PLATELET-RICH PLASMA GEL; Biological: ADIPOSE TISSUE EXTRACT

• Registration Number: NCT02799290
• Lead Sponsor: Tampere University

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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Results First Submitted: 2016-10-26
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-13
• Last Update Submitted: 2020-12-13
• Results First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• donor site indication

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLATELET-RICH PLASMA GEL	PLATELET-RICH PLASMA GEL	PLATELET RICH PLASMA GEL APPLICATION
ADIPOSE TISSUE EXTRACT	ADIPOSE TISSUE EXTRACT	Adipose Tissue extract application

Primary Outcome Measures

Name	Time	Method
Wound Re-epithelization	30 days	observational-digital photography with specialized custom-made software

Secondary Outcome Measures

Name	Time	Method
Melanin Concentration in Wound	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.
Scar Properties	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
Oxygenated Hemoglobin	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.

Trial Locations

Locations (1)

Jenny Lopez, Ilkka Kaartinen; 🇫🇮 Tampere, Pirkanmaa, Finland