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Direct Use of Non-centrifuged Autologous Fat Graft

Sponsor
Samsun Liv Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04896437
Collaborator
(none)
16
Enrollment
48.5
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: non-centrifuge fat graft application to the 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.

Study Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Direct Use of Autologous Fat Graft on The Treatment of Lower Extremity Wounds
Actual Study Start Date :
Mar 2, 2016
Actual Primary Completion Date :
May 13, 2019
Actual Study Completion Date :
Mar 18, 2020

Outcome Measures

Primary Outcome Measures

  1. Wounds examination [6 months]

    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.

Secondary Outcome Measures

  1. Wounds classification according to data from files and photographs [3 months]

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

  2. Final evaluation and data achieving from files and exam carts [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Samsun Liv Hospital

Investigators

  • Principal Investigator: Umut Tuncel, Assoc Prof, Samsun Liv Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samsun Liv Hospital
ClinicalTrials.gov Identifier:
NCT04896437
Other Study ID Numbers:
  • Retrospective study
First Posted:
May 21, 2021
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samsun Liv Hospital
diabetic food
lower extremity
fat graft
nonentrifuged

Study Results

No Results Posted as of May 21, 2021