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Wound Healing DelayedNCT04896437

Direct Use of Non-centrifuged Autologous Fat Graft

An observational study of Wound Healing Delayed, run by Samsun Liv Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are a limited number of reports related to the direct use of non-centrifuged adipose tissue graft in the literature. This preliminary study aims to present our experience on the efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity wounds. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Wound Healing Delayed
What is being tested?
non-centrifuge fat graft application to the wounds
Type of treatment
Surgery or procedure
How many people
16 participants
Where
No sites listed yet
Study dates
2 Mar 2016to 18 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 16 lower extremity wounds were included in the study between January 2016-October 2019 years. All patients were treated by two surgeons in the same clinic. The wounds were those that continued for at least three months of high to moderate exudate and required open management of the secondary intervention. The etiologies of the wounds were diabetic, venous or traumatic ulcers.

Who may be able to join

  • diabetic,
  • venous
  • traumatic wounds

Who cannot join

  • Malignancy,
  • A life expectation <1 year,
  • Chemical or radiation exposure.
  • Pregnancy

About this study

Official title: Direct Use of Autologous Fat Graft on The Treatment of Lower Extremity Wounds

There are a limited number of reports related to the direct use of non-centrifuged adipose tissue graft in the literature. This preliminary study aims to present our experience on the efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity wounds.

Read the detailed description

16 wounds treated with non-centrifuged autologous fat grafts were included in the study. The data were retrospectively analyzed. VAC (vacuum-assisted therapy) or silver-impregnated dressing was used to achieve a healthy wound bed before fat grafting. Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.

Being tested
non-centrifuge fat graft application to the wounds
Keywords
diabetic food, lower extremity, fat graft, nonentrifuged

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-centrifuge fat graft application to the woundsProcedure or surgery

    Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wounds examination

    Collection of the data from clinical observation and photograph records were made to follow the wounds. the observations were made during changing the wound dressing and generally every three days.

    Measured: 6 months

Secondary outcomes (2)

  1. Wounds classification according to data from files and photographs

    In this season the data will be classified according to the wounds parameters and photograph

    Measured: 3 months

  2. Final evaluation and data achieving from files and exam carts

    all data will be examined and evaluated whether there is any difference between probable groups

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start2 Mar 2016
  3. Primary completion13 May 2019
  4. Study completion18 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896437
Sponsor's protocol ID
Retrospective study
Status last verified
May 2021
First submitted
6 May 2021
Last updated
21 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goncalves AI, Gershovich PM, Rodrigues MT, Reis RL, Gomes ME. Human adipose tissue-derived tenomodulin positive subpopulation of stem cells: A promising source of tendon progenitor cells. J Tissue Eng Regen Med. 2018 Mar;12(3):762-774. doi: 10.1002/term.2495. Epub 2017 Oct 4.

    PubMed 28593712

  • Hivernaud V, Lefourn B, Robard M, Guicheux J, Weiss P. Autologous fat grafting: A comparative study of four current commercial protocols. J Plast Reconstr Aesthet Surg. 2017 Feb;70(2):248-256. doi: 10.1016/j.bjps.2016.11.022. Epub 2016 Dec 14.

    PubMed 28043786

  • Conde-Green A, Marano AA, Lee ES, Reisler T, Price LA, Milner SM, Granick MS. Fat Grafting and Adipose-Derived Regenerative Cells in Burn Wound Healing and Scarring: A Systematic Review of the Literature. Plast Reconstr Surg. 2016 Jan;137(1):302-312. doi: 10.1097/PRS.0000000000001918.

    PubMed 26710034

  • Tuncel U, Kostakoglu N, Turan A, Cevik B, Cayli S, Demir O, Elmas C. The Effect of Autologous Fat Graft with Different Surgical Repair Methods on Nerve Regeneration in a Rat Sciatic Nerve Defect Model. Plast Reconstr Surg. 2015 Dec;136(6):1181-1191. doi: 10.1097/PRS.0000000000001822.

    PubMed 26273733

  • Moyer HR, Namnoum JD. Autologous Fat Transfer: The Progenitor Cell Response to Different Recipient Environments. Aesthet Surg J. 2014 Aug;34(6):932-40. doi: 10.1177/1090820X14536903. Epub 2014 Aug 1.

    PubMed 24936093

  • Hyldig K, Riis S, Pennisi CP, Zachar V, Fink T. Implications of Extracellular Matrix Production by Adipose Tissue-Derived Stem Cells for Development of Wound Healing Therapies. Int J Mol Sci. 2017 May 31;18(6):1167. doi: 10.3390/ijms18061167.

    PubMed 28561757

  • van de Vyver M. Intrinsic Mesenchymal Stem Cell Dysfunction in Diabetes Mellitus: Implications for Autologous Cell Therapy. Stem Cells Dev. 2017 Jul 15;26(14):1042-1053. doi: 10.1089/scd.2017.0025. Epub 2017 May 18.

    PubMed 28447876

  • Hur W, Lee HY, Min HS, Wufuer M, Lee CW, Hur JA, Kim SH, Kim BK, Choi TH. Regeneration of full-thickness skin defects by differentiated adipose-derived stem cells into fibroblast-like cells by fibroblast-conditioned medium. Stem Cell Res Ther. 2017 Apr 20;8(1):92. doi: 10.1186/s13287-017-0520-7.

    PubMed 28427476

Questions about this trial

What is this clinical trial studying?

An observational study of Wound Healing Delayed, run by Samsun Liv Hospital.

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 3 inclusion and 4 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 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Wounds examination (time frame: 6 months). 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 NCT04896437, which also lists 8 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 21 May 2021.

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