Improving facial scars: comparing two fat grafting techniques using a nanofat graft

ISRCTN	ISRCTN64292493
DOI	https://doi.org/10.1186/ISRCTN64292493

Submission date: 14/04/2024
Registration date: 22/04/2024
Last edited: 22/04/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Despite the variety of therapeutic techniques used to improve the appearance of disfiguring scars, there is still no method that achieves perfect results, and nanofat injections have shown clinical benefits in rejuvenating the skin and improving the appearance of scars. Additionally, the concurrent use of platelet-rich fibrin with nanofat has shown an enhanced effect.

Who can participate?
Patients aged 18 years old and over with atrophic linear facial scars

What does the study involve?
This study compares two groups of patients with atrophic facial scars. A control group will receive nanofat grafting and in contrast, the experimental group will receive unfiltered nanofat grafting with platelet-rich fibrin.

What are the possible benefits and risks of participating?
One of the features of nanofat grafting is the regeneration and improvement of the scar's texture and color in terms of pigmentation, restoring its thickness to the normal proportion of the surrounding skin. It is a safe, easy, and effective method due to its high content of adipose-derived stem cells. However, this method has several limitations, including the presence of a donor surgical site and consequent complications such as pain, swelling, and infection.

Where is the study run from?
Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Syria

When is the study starting and how long is it expected to run for?
January 2021 to January 2024

Who is the funding of the study?
Investigator initiated and funded

Who is the main contact?
Dr Mhd Anas Alnemr, anas.alnmer@gmail.com

Contact information

Dr Mhd Anas Alnemr
Public, Scientific, Principal Investigator

Mezzeh Highway
Damascus
0000
Syria

ORCID ID	0009-0002-9047-3030
Phone	+963957432950
Email	anas1.alnmer@damascusuniversity.edu.sy

Dr Mhd Anas Alnemr
Public

Mezzeh Highway
Damascus
0000
Syria

Phone	+963957432950
Email	anas.alnmer@gmail.com

Study information

Study design	Single-blind randomized controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Medical and other records, University/medical school/dental school
Study type	Treatment, Efficacy
Participant information sheet	45318_PIS.pdf
Scientific title	The management of facial scars by using unfiltered nanofat graft mixed with platelet-rich fibrin or conventional nanofat graft
Study hypothesis	The use of nanofat mixed with platelet-rich fibrin is effective in the management of atrophic facial scars compared to conventional nanofat.
Ethics approval(s)	Approved 21/03/2021, Ethics Scientific Committee at Damascus University (Oral and Maxillofacial Surgery Department - Faculty of Dental Medicine - Damascus University, Damascus, 4671, Syria; +963 11 33923011; verification.dicr@damascusuniversity.edu.sy), ref: DN-210224-11-H8
Condition	Improving the appearance of atrophic facial scars in patients
Intervention	This study is a randomized controlled trial, including 2 groups of patients with atrophic facial scars - the control group will receive nanofat grafting. In contrast, the experimental group will receive unfiltered nanofat grafting with platelet-rich fibrin (PRF). Participants will be randomized into 2 groups using https://www.randomizer.org/. The follow-up for each patient is 6 months with 3 visits for each patient: 1. One week postoperative 2. ⁠3 months postoperative 3. ⁠6 months postoperative The primary outcome of the study is assessed using the Patient And Observer Scar Assessment Scale (POSAS) in 2 parts, firstly by 3 observers and secondly by the patient himself/herself. The observers will assess scar quality (vascularity, pigmentation, thickness, relief, pliability and surface area) on a scale from 1 to 10. While the patient will assess according to the following parameters from 1 to 10: pain, itchiness, color, stiffness, thickness and irregularity.
Intervention type	Procedure/Surgery
Primary outcome measure	Scar quality from the perspectives of the patient and the clinician measured using the Patient And Observer Scar Assessment Scale (POSAS) at baseline (T0: preoperative), 3 (T1) and 6 (T2) months postoperative
Secondary outcome measures	The following secondary outcome measures will be assessed at baseline (T0: preoperative), 3 (T1) and 6 (T2) months postoperative: 1. Scar appearance measured in 4 grades (Level 1: Macular Scar; Level 2: Mild Scar; Level 3: Moderate Scar; and, Level 4: Severe Scar) by 3 observers using the Goodman and Baron Scale 2. Aesthetic improvement measured using the Global Aesthetic Improvement Scale (7 levels: -3 = Very Much Worse; -2 = Much Worse; -1 = Worse; 0 = No Change; 1 = Improved; 2 = Much Improved; and, 3 = Very Much Improved)
Overall study start date	19/01/2021
Overall study end date	20/01/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	21 Years
Upper age limit	47 Years
Sex	Both
Target number of participants	20
Total final enrolment	24
Participant inclusion criteria	1. Patients with atrophic linear facial scars 2. The length of the scar is more than 2 centimeters 3. Patients older than 18 years old 4. No systemic disease and syndromes 5. Previously untreated scars
Participant exclusion criteria	1. Patients with acute skin disease 2. Patients with bleeding disorder 3. Patients has gone through severe weight gain/loss during the past few months 4. Skinny patients (does not have enough fat tissue in the donor sites)
Recruitment start date	01/03/2022
Recruitment end date	01/03/2023

Locations

Countries of recruitment

Syria

Study participating centre

Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University

Mazzeh Highway
Damascus
4671
Syria

Sponsor information

Damascus University
University/education

Mazzeh Highway
Damascus
4671
Syria

Phone	+963944812030
Email	vice.research@damascusuniversity.edu.sy
Website	https://www.damascusuniversity.edu.sy/
"ROR"	https://ror.org/03m098d13

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	24/04/2024
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			22/04/2024	No	Yes

Additional files

45318_PIS.pdf

Editorial Notes

15/04/2024: Study's existence confirmed by the Ethics Scientific Committee at Damascus University.