Nanofat in Post Burn Scars on the Face

Burn Scar Clinical Trial

Official title:

Rejuvenation of Post Burn Scars on the Face With Unfiltered Nanofat Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352297
• Other study ID #: 249/PLS/MHL
• Status: Completed
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 22, 2017
• Start date: January 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Post burn scars on the face

• Fitzpatrick skin types between 3 and 4

Exclusion Criteria:

• Hypertrophic scars

• Contractures

• Keloids

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

References & Publications (12)

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

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

Gu Z, Li Y, Li H. Use of Condensed Nanofat Combined With Fat Grafts to Treat Atrophic Scars. JAMA Facial Plast Surg. 2017 Sep 21. doi: 10.1001/jamafacial.2017.1329. [Epub ahead of print] — View Citation

Illouz YG. Body contouring by lipolysis: a 5-year experience with over 3000 cases. Plast Reconstr Surg. 1983 Nov;72(5):591-7. — View Citation

Jaspers ME, Brouwer KM, van Trier AJ, Groot ML, Middelkoop E, van Zuijlen PP. 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: 10.1 — View Citation

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. — View Citation

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. Epub 2017 Apr 12. — View Citation

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: — View Citation

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

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. — View Citation

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):1017-26. doi: 10.1097/PRS.0b013e31829fe1b0. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejuvenation of post burn scars on the face with unfiltered nanofat injection	Pre and post-operative POSAS score	1 year