Direct Use of Non-centrifuged Autologous Fat Graft

Wound Healing Delayed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896437
• Other study ID #: Retrospective study
• Status: Completed
• Start date: March 2, 2016
• Est. completion date: March 18, 2020

Study information

• Verified date: May 2021
• Source: Samsun Liv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 18, 2020
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing Delayed

Intervention

Procedure:
• non-centrifuge fat graft application to the wounds
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Liv Hospital

References & Publications (8)

Condé-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. Review. — View Citation

Gonçalves 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. — View 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. — View 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. — View 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). pii: E1167. doi: 10.3390/ijms18061167. Review. — View 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. — View Citation

Tuncel U, Kostakoglu N, Turan A, Çevik B, Çayli 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Wounds classification according to data from files and photographs	In this season the data will be classified according to the wounds parameters and photograph	3 months
Secondary	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	3 months