Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face

October 25, 2023 updated by: Afzaal Bajwa, King Edward Medical University
Pigmentary changes are commonly associated with contour defects of facial region. These deformities cause cosmetic concerns. Traditionally used techniques indwelling limitations and therefore it invokes innovative techniques to treat contour abrasion and pigmentation simultaneously. The current study focuses on evaluation of the role of autologous fat in improving contour defects of face associated with hyperpigmentation. 100 subjects having contour defects related skin pigmentation were recruited from Feb 2022 till Feb 2023. Fat was harvested, processed under sterilized conditions and grafted into the affected regions of face. The patients were kept under follow up for one year after fat injection. Subjective as well as objective evaluation was done before treatment and one year after fat injection. Results showed significant improvement in pigmentation after fat injection. Most of the patients had high satisfaction regarding improvement in pigmentation and pliability of the grafted area after use of fat graft. A software Image J was applied to objectively showing changes in hyperpigmentation of face after fat graft. In conclusion, utility of autologous fat has effective and promising role as an ideal filler for treating contour defects of face with pigmentary changes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Facial contour defects need augmentation have pigmentary issues related to them. Such defects are noticed after trauma, autoimmune disease or after infection. These combined contour and pigmentary defects cause social as well as aesthetic concerns. Discolored skin makes them more prominent. Conventionally, fillers are employed but these are short lived at one hand while do not treat pigmentation on the other hand. Body tissues in the form of flaps have also been tried but with the same outcome as with the fillers. Lasers and chemical depigmentation improve skin color but has to do nothing with filling of the contour. In short so far, no single satisfactory remedy is available for such issues. Therefore, some innovative strategy is needed which can fill contour defect and resolves pigmentation too.

Adipose tissue, being autologous, is a pronounced source with regenerative potential as well as natural augmentation. Due to its abundance, easy harvesting and pliability at recipient site make it ideal. Filling effect is just one aspect rather grafted fat not only softens scars, rejuvenates skin but also improves pigmentation. Therefore, in our study we aimed at the evaluation of fat as an ideal filler.

Materials and Methods This prospective study was conducted in Plastic & Reconstructive Surgery Department of KEMU Lahore from Feb 2022 to Feb 2023. Hundred patients of both genders and age between 10 to 50 years having contour defects on face were recruited.

Patients having rejuvenation procedure like filler, laser, depigmentation or PRP done were excluded from the study. Biodata along with deformity details were noted. Advantages, limitations and likely complications related to the procedure were explained and informed consent was documented.

Pre-procedure skin texture, color and defect was noted. Donor area was marked and local anesthesia with 0.5% Xylocain and 1:500,000 Adrenaline in normal saline was infiltrated with one milliliter of fluid for one milliliter of fat to be procured. Fat was procured with blunt 2-mm multi-hole cannula using 10cc Luer-Lok syringe under manual suction applied not more than 2ml. Then fat was transferred to recipient area by using Icc syringe and infiltration canula till symmetry achieved with contralateral respective area of face. Grafted area photographed and integrated color density (ICD1) was found with ImageJ. All patients were observed for 24 hours to look for any complication. Oral analgesic and antibiotics were prescribed for 3 days. Patients were kept under monthly follow up and sessions were repeated if required (13). Subjective as well as objective measurement of outcomes was done. For objective evaluation, repeat photograph was taken after one year of deformity got resolved. Integrated color density (ICD2) was again measured and compared with ICD1. For subjective evaluation, patient's was noted.

Findings were recorded and variables like age, gender, area involved, duration, ICD and satisfaction documented. SPSS 22 used for data analysis with p- Value <0.05 considered significant.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • King Edward Medical University

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pigmentation with contour defect

Exclusion Criteria:

  • Unfit for anesthesia

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fat Grafting
It is an experimental study for effect of fat grafting on pigmentation of skin
Autologous fat grafted at contour defects with pigmentary changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDC
Time Frame: 6 Months
integrated color density
6 Months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Afzaal Bashir, FACS, MS, King Edward Medical University, Lahore, Pakistan

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)

February 22, 2022

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kemu/23/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Statistical data to be shared

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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