Direct Use of Non-centrifuged Autologous Fat Graft

Completed

• Conditions: Wound Healing Delayed

• Registration Number: NCT04896437
• Lead Sponsor: Samsun Liv Hospital

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.

Study Timeline

• Study Start: 2016-03-02
• Primary Completion: 2019-05-13
• Study Completion: 2020-03-18
• Status Verified: 2021-05
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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