Direct Use of Non-centrifuged Autologous Fat Graft

May 17, 2021 updated by: Samsun Liv Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wounds examination
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wounds classification according to data from files and photographs
Time Frame: 3 months
In this season the data will be classified according to the wounds parameters and photograph
3 months
Final evaluation and data achieving from files and exam carts
Time Frame: 3 months
all data will be examined and evaluated whether there is any difference between probable groups
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Liv Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2016

Primary Completion (Actual)

May 13, 2019

Study Completion (Actual)

March 18, 2020

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Retrospective study (Other Identifier: CHRU of NANCY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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