NCT03352297

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 15, 2017

Last Update Submit

November 22, 2017

Conditions

Burn Scar

Keywords

Post burn scar faceUnfiltered nanofatAdipose tissue growth factorsAdipose stem cellsPOSASImage JFace

Outcome Measures

Primary Outcomes (1)

  • Rejuvenation of post burn scars on the face with unfiltered nanofat injection

    Pre and post-operative POSAS score

    1 year

Interventions

Unfiltered Nanofat GraftBIOLOGICAL

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hypertrophic scars
  • Contractures
  • Keloids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

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

    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.

    PMID: 6622564BACKGROUND

  • 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.

    PMID: 8226158BACKGROUND

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

    PMID: 11248861BACKGROUND

  • 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.

    PMID: 11304456BACKGROUND

  • 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.

    PMID: 23783059RESULT

  • 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.

    PMID: 28406706RESULT

  • 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

    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.

    PMID: 27632398RESULT

  • 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.

    PMID: 23486128RESULT

  • 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.

    PMID: 21355887RESULT

  • 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.

    PMID: 28975248RESULT

  • 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.

    PMID: 30285990DERIVED

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saadia Jan, FRCS ed, FCPS

    King Edward Medical University Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 24, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 24, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share