Clinical trial NCT04896437: Direct Use of Non-centrifuged Autologous Fat Graft
Official title: Direct Use of Autologous Fat Graft on The Treatment of Lower Extremity Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Healing Delayed
Keywords: diabetic food
lower extremity
fat graft
nonentrifuged
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. diabetic,
2. venous
3. traumatic wounds

Exclusion Criteria:

1. Malignancy,
2. A life expectation \<1 year,
3. Chemical or radiation exposure.
4. Pregnancy

Primary outcomes:
measure: Wounds examination
timeFrame: 6 months
Secondary outcomes:
measure: Wounds classification according to data from files and photographs
timeFrame: 3 months
measure: Final evaluation and data achieving from files and exam carts
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Samsun Liv Hospital
name: Umut Tuncel, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.