Nanofat in Post Burn Scars on the Face

NCT ID: NCT03352297

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Quasi-Experimental Study: Unfiltered Nanofat Injected into Postburn Facial Scars Number of Patients: 48 Outcome Assessed on POSAS And with Imaje J Scanning Preop And Postop Statistical Comparison of Scar Done

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: To compare the quality of post burn facial scars before and after injection of unfiltered nanofat.

Place and Duration of Study: Plastic Surgery Department, Mayo Hospital, Lahore, from January 2016 to December 2016.

Methodology: 48 patients with post burn facial scars were included, age range 4 to 32 years with Fitzpatrick skin types between 3 and 4. Patients with hypertrophic scars, contractures or keloids were excluded. Scars were assessed by a senior plastic surgeon and the patient on the POSAS. Fat was harvested from the abdomen and/or thighs with a 3 mm multi-port liposuction cannula (containing several sharp side holes of 1 mm) using Coleman's technique, emulsified, and transferred into 1 ml Leur lock syringes for injection into the subdermal or intradermal plane. Final follow up was scheduled at 6 months and scar was rated by the patient and the same surgeon on the POSAS. Pre and post op scar scores were compared and p-values calculated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burn Scar

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Post burn scar face Unfiltered nanofat Adipose tissue growth factors Adipose stem cells POSAS Image J Face

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unfiltered Nanofat Graft

Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Post burn scars on the face
* Fitzpatrick skin types between 3 and 4

Exclusion Criteria

* Hypertrophic scars
* Contractures
* Keloids
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Muhammad Mustehsan Bashir

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saadia Jan, FRCS ed, FCPS

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University Lahore

References

Explore related publications, articles, or registry entries linked to this study.

Neuber G. Über die Wiederanheilung vollständig vom Körper getrennter, die ganze Fettschicht enthaltender Hautstücke. Zentralblatt Chir. 1893;30:16

Reference Type BACKGROUND

Illouz YG. Body contouring by lipolysis: a 5-year experience with over 3000 cases. Plast Reconstr Surg. 1983 Nov;72(5):591-7. doi: 10.1097/00006534-198311000-00001.

Reference Type BACKGROUND
PMID: 6622564 (View on PubMed)

Stuschke M, Budach V, Sack H. Radioresponsiveness of human glioma, sarcoma, and breast cancer spheroids depends on tumor differentiation. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):627-36. doi: 10.1016/0360-3016(93)90389-d.

Reference Type BACKGROUND
PMID: 8226158 (View on PubMed)

Coleman SR. Structural fat grafts: the ideal filler? Clin Plast Surg. 2001 Jan;28(1):111-9.

Reference Type BACKGROUND
PMID: 11248861 (View on PubMed)

Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

Reference Type BACKGROUND
PMID: 11304456 (View on PubMed)

Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.

Reference Type RESULT
PMID: 23783059 (View on PubMed)

Lo Furno D, Tamburino S, Mannino G, Gili E, Lombardo G, Tarico MS, Vancheri C, Giuffrida R, Perrotta RE. Nanofat 2.0: experimental evidence for a fat grafting rich in mesenchymal stem cells. Physiol Res. 2017 Sep 22;66(4):663-671. doi: 10.33549/physiolres.933451. Epub 2017 Apr 12.

Reference Type RESULT
PMID: 28406706 (View on PubMed)

Goisis M, Stella E, Di Petrillo A, Rosset L. Nanofat Grafting Compared to Hyaluronic Acid and PRP Treatment of the Lower Lid and Tear Trough: Clinical Outcome. JSM Ophthalmology. 2015;3:1027

Reference Type RESULT

Jaspers MEH, Brouwer KM, van Trier AJM, Groot ML, Middelkoop E, van Zuijlen PPM. Effectiveness of Autologous Fat Grafting in Adherent Scars: Results Obtained by a Comprehensive Scar Evaluation Protocol. Plast Reconstr Surg. 2017 Jan;139(1):212-219. doi: 10.1097/PRS.0000000000002891.

Reference Type RESULT
PMID: 27632398 (View on PubMed)

Mailey B, Saba S, Baker J, Tokin C, Hickey S, Wong R, Wallace AM, Cohen SR. A comparison of cell-enriched fat transfer to conventional fat grafting after aesthetic procedures using a patient satisfaction survey. Ann Plast Surg. 2013 Apr;70(4):410-5. doi: 10.1097/SAP.0b013e31827e5353.

Reference Type RESULT
PMID: 23486128 (View on PubMed)

Kim JH, Jung M, Kim HS, Kim YM, Choi EH. Adipose-derived stem cells as a new therapeutic modality for ageing skin. Exp Dermatol. 2011 May;20(5):383-7. doi: 10.1111/j.1600-0625.2010.01221.x. Epub 2011 Feb 28.

Reference Type RESULT
PMID: 21355887 (View on PubMed)

Gu Z, Li Y, Li H. Use of Condensed Nanofat Combined With Fat Grafts to Treat Atrophic Scars. JAMA Facial Plast Surg. 2018 Mar 1;20(2):128-135. doi: 10.1001/jamafacial.2017.1329.

Reference Type RESULT
PMID: 28975248 (View on PubMed)

Jan SN, Bashir MM, Khan FA, Hidayat Z, Ansari HH, Sohail M, Bajwa AB, Shami HB, Hanif A, Aziz F, Choudhery MS. Unfiltered Nanofat Injections Rejuvenate Postburn Scars of Face. Ann Plast Surg. 2019 Jan;82(1):28-33. doi: 10.1097/SAP.0000000000001631.

Reference Type DERIVED
PMID: 30285990 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

249/PLS/MHL

Identifier Type: -

Identifier Source: org_study_id