Wound Healing Disturbance ofPhase 2NCT02799290
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
A Phase 2 study testing ADIPOSE TISSUE EXTRACT and PLATELET-RICH PLASMA GEL in people with Wound Healing Disturbance of, run by Tampere University at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Healing Disturbance of
- What is being tested?
- ADIPOSE TISSUE EXTRACT and PLATELET-RICH PLASMA GEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2015to May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- donor site indication
Who cannot join
- immunosupressive states
- terminal renal insufficiency
- pregnancy
- coagulation dyscrasias
- active infection in donor site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adipose Tissue Extract and Platelet-rich Plasma on Split-thickness Donor Site Wound Healing. A Comparative Study
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.
Read the 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.
- Conditions
- Wound Healing Disturbance of
- Being tested
- ADIPOSE TISSUE EXTRACT, PLATELET-RICH PLASMA GEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADIPOSE TISSUE EXTRACTBiological
Also called ATE
Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
PLATELET-RICH PLASMA GELBiological
Also called PRP
Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | No intervention |
| ADIPOSE TISSUE EXTRACT | Experimental | Adipose Tissue extract application Receives: Biological: ADIPOSE TISSUE EXTRACT |
| PLATELET-RICH PLASMA GEL | Experimental | PLATELET RICH PLASMA GEL APPLICATION Receives: Biological: PLATELET-RICH PLASMA GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Re-epithelization
observational-digital photography with specialized custom-made software
Measured: 30 days
Secondary outcomes (3)
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
Measured: 30 and 60 days
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.
Measured: day 30 and 60
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.
Measured: day 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound Healing Disturbance ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Lopez, Tampere University
- Investigators
- Timo Ylikomi, PhD, Study director, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799290
- Sponsor's protocol ID
- R15034
- Status last verified
- Dec 2020
- First submitted
- 9 Jun 2016
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: If required, individual data can be shown
Publications
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.
PubMed 21902602Sarkanen 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.
PubMed 22738319
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adipose Tissue Extract and Platelet-rich Plasma on Split-thickness Donor Site Wound Healing. A Comparative Study
- ClinicalTrials.gov ID
- NCT02799290
- Acronym / sponsor ID
- R15034
- Conditions
- Wound Healing Disturbance of
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –No intervention |
| ADIPOSE TISSUE EXTRACT | Experimental | Biological: ADIPOSE TISSUE EXTRACTAdipose Tissue extract application |
| PLATELET-RICH PLASMA GEL | Experimental | Biological: PLATELET-RICH PLASMA GELPLATELET RICH PLASMA GEL APPLICATION |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- donor site indication
Key exclusion criteria (5 listed)
- immunosupressive states
- terminal renal insufficiency
- pregnancy
- coagulation dyscrasias
- active infection in donor site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADIPOSE TISSUE EXTRACTAlso: ATEAdipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration | Biological | ADIPOSE TISSUE EXTRACT |
| PLATELET-RICH PLASMA GELAlso: PRPAutologous platelet rich plasma is obtained onsite and activated following commercial kit instructions | Biological | PLATELET-RICH PLASMA GEL |
Primary outcome
Wound Re-epithelization
Time frame: 30 days
observational-digital photography with specialized custom-made software
3 secondary outcomes
Scar Properties
Time frame: 30 and 60 days
Oxygenated Hemoglobin
Time frame: day 30 and 60
Melanin Concentration in Wound
Time frame: day 30 and 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21902602Sarkanen 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 publication: PubMed 22738319Sarkanen 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.
- Individual participant dataSharing planned: No. If required, individual data can be shown
Related trials for Wound Healing Disturbance of
Recruiting
HIP-STITCH (Wound Recovery After THA)
Wound Healing Disturbance of
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Ylikomi, PhD study director
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADIPOSE TISSUE EXTRACT and PLATELET-RICH PLASMA GEL in people with Wound Healing Disturbance of, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Re-epithelization (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.