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Anthony P. Sclafani, MD, PRFM, Facial

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Anthony P. Sclafani, MD, PRFM, Facial

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dimiz77
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ORIGINAL ARTICLE

ONLINE FIRST
Safety, Efficacy, and Utility of Platelet-Rich Fibrin
Matrix in Facial Plastic Surgery
Anthony P. Sclafani, MD

Objective: To evaluate the clinical safety and efficacy 1-5 treatments). No patients reported any swelling last-
of the use of autologous platelet-rich fibrin matrix (PRFM) ing longer than 5 days, and most noted only minimal
in facial plastic surgery. bruising lasting for 1 to 3 days. Most patients were sat-
isfied with the results of their treatments, although 1 pa-
Methods: Medical charts of the last 50 patients with at tient felt that there was limited or no improvement after
least 3 months of follow-up who were treated by the au- 2 treatments.
thor with PRFM for aesthetic purposes were reviewed
for patient satisfaction, objective clinical results, and
Conclusions: Autologous PRFM treatment is a well-
adverse events.
tolerated, excellent choice for use in the face. Further stud-
Results: The study cohort of patients was followed up
ies on the precise mechanism of action of PRFM are
for a mean (SD) of 9.9 (8.0) months (range, 3-30 months). ongoing.
Most patients were treated for deep nasolabial folds, while
the volume-depleted midface region, superficial rhytids, Arch Facial Plast Surg. 2011;13(4):247-251.
and acne scars were other commonly treated areas. The Published online February 21, 2011.
patients underwent an average of 1.6 treatments (range, doi:10.1001/archfacial.2011.3

G
ROWTH FACTORS (GFS) investigators who were studying epider-
have long represented an mal GF noted that the effect of exog-
area of interest for sur- enous epidermal GF was transient and
geons attempting to that sustained application of epidermal
modify and enhance the GF enhanced wound repair.7
wound-healing process. However, a single Platelet-rich fibrin matrix (PRFM) (Sel-
GF application has had infrequent clini- phyl; Aesthetic Factors, Wayne, New Jer-
cal success.1,2 Autologous GFs, derived sey) is distinct from PRP and can be pro-
from platelets, are the primary agents of duced with as little as 9 mL of peripheral
action in the platelet-rich plasma (PRP) blood. It is collected in a vacuum-sealed
that is used currently. However, studies in collection tube with a thixotropic separa-
facial plastic surgery have been equivocal tor gel, and the tube is centrifuged for 6
in demonstrating clinical benefit with minutes at 1100 rpm. This process sepa-
PRP.3-5 Also, PRP systems generally re- rates the red and white blood cells from
quire large volumes of blood yet produce the plasma and platelets, which are then
small volumes of PRP. More importantly, transferred in a closed system to a second
most PRP systems rely on animal- tube containing calcium chloride; it is this
derived thrombin to initiate platelet de- small amount of calcium that initiates the
granulation, and no system has been fibrinogen cleavage and the fibrin polym-
shown to produce sustained GF release. erization. The resultant mixture can be eas-
Author Affiliations: Division of This “1-time” GF release that is asso- ily injected through a 30-gauge needle for
Facial Plastic and ciated with PRP use may explain the approximately 10 to 12 minutes, after
Reconstructive Surgery,
transient effect of PRP on wound heal- which the polymerization of the fibrin pro-
The New York Eye and Ear
Infirmary, New York, New York; ing noted by Sclafani et al,6 who found duces a solid fibrin clot.
and Department of an increase in endothelial cells and Platelet-rich fibrin matrix does not pro-
Otolaryngology, New York fibroblasts 7 days after creating an duce the very high platelet concentra-
Medical College, Valhalla, experimental wound; however, this tions that are seen in PRP. Rather, it more
New York. enhancement was lost by day 14. Other closely replicates the wound response. It

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PREPARATION OF PRFM
Table. The Average Volumes Injected, by Area
Autologous PRFM was prepared with the following system:
Area Injected/Treated Volume, Mean (SD), mL Briefly, 9 mL of peripheral blood was collected in a specialized
Superficial rhytids vacuum-sealed collection tube containing an anticoagulant (so-
Forehead 0.30 (0.10) dium citrate) and a separator gel. Next, the tube was centri-
Glabella 0.38 (0.17) fuged for 6 minutes at 1100 rpm, separating the cellular com-
Crow’s feet 0.48 (0.25) ponents below the gel and plasma and platelets above the gel.
Tear trough 0.65 (0.43) Platelets and plasma were then transferred to a second tube con-
Orbital hollow 1.00 (0.38) taining calcium chloride, and the PRFM was injected using a
Nasolabial fold 1.67 (0.78) 27- or 30-gauge needle into the dermis, subdermis, or preperi-
Marionette fold 0.80 (0.31) osteal plane as needed.
Midfacial volume
Cheek 1.59 (0.71)
Malar eminence 1.08 (0.11) PRFM APPLICATION
Upper lip 2.50 (0.17)
Lower lip 1.50 (0.10) Fine rhytids are injected intradermally, while deeper folds and
Mental crease 0.51 (0.30) areas of volume deficiency are injected at the dermal-
Prejowl sulcus 0.50 (0.33) subdermal border. Some areas requiring significant volume aug-
Acne scars (with subcision) mentation may also be injected into deep fat (midface) or pre-
Forehead 0.47 (0.25)
periosteally (suborbital hollows). Depressed or acne scars are
Temple 0.86 (0.35)
treated with a combination of subcision followed immediately
Cheek 2.25 a
Surgery, lateral osteotomy site 1.50 a
by subdermal injection of PRFM. Surgical applications of PRFM
Cheek or chin implant 2.00 a
include rhinoplasty, in which PRFM is injected along the lat-
Rhytidectomy 2.00 a eral osteotomy site; rhytidectomy, in which PRFM is placed in
a thin layer over the flap bed before closure; and autologous
a All injection volumes were the same for each area; therefore, there was fat transfer, in which PRFM is mixed with fat in a 1:2 ratio10,11
no variance. just before fat injection.

RESULTS
includes the formation of a 3-dimensional cross-linked
fibrin matrix, which is essential to the platelet plug, as it The study included 44 women and 6 men , with a mean
serves as a binding site for both platelets and GFs. This (SD) age of 51.3 (12.6) years (age range, 23.5-72.5 years).
scaffolding helps localize the GFs, essentially increas- The patients were treated an average of 1.8 times (range,
ing the local concentration at the desired location to guide 1-5 treatments). Most patients were Fitzpatrick skin type
tissue regeneration. II or III, but 4 patients were skin type IV. The indica-
I previously described my early clinical experience tions for treatment are listed below.
with PRFM8 and reported the results of a clinical trial Indication No. of Patients
of PRFM for the improvement of deep nasolabial Nasolabial folds 30
folds.9 In the latter study, patients were treated with a Facial volumization 11
single (intradermal and/or subdermal) injection of Superficial rhytids 10
PRFM for moderately severe nasolabial folds. Clini- Acne scars 6
Rhinoplasty 4
cally significant improvement in the nasolabial folds
Facial implant 2
was noted as early as 2 weeks after treatment, with Autologous fat transfer 2
slight improvement (no loss of correction) over the Rhytidectomy 2
following 10 weeks of the trial. Depressed scar 1
Since 2008, I have used PRFM to treat deep nasola-
bial folds and superficial rhytids as well as for facial vo- The average volumes injected, by area, are listed in
lumization and depressed or acne scars (in combination the Table. The mean (SD) duration of follow-up was 9.9
with subcision), mixed with fat (as described by oth- (8.0) months (range, 3-30 months).
ers10,11), and to accelerate wound healing in face-lifts, fa- Patients generally noted that the correction seen
cial implants, and lateral osteotomies in rhinoplasties. This immediately after treatment subsided partially over the
article presents a review of 50 cases that were treated with first 24 to 72 hours afterward. Most patients noted
PRFM in my practice. only mild bruising, which was easily covered with cos-
metics, for the first 1 to 3 days, although a few patients
METHODS
(especially those treated in the periorbital area) expe-
rienced ecchymosis lasting up to 14 days. Most
patients perceived noticeable improvement in the
Office medical charts were reviewed to identify the last 50
patients who had been treated with PRFM with a minimum of
treated areas by 5 to 7 days after treatment, and almost
3 months of follow-up. They were reviewed for patient demo- all (approximately 90%) noticed continued improve-
graphics as well as for the following PRFM treatment para- ment until 2 to 4 weeks after treatment. Five patients
meters: specific intended goals of treatment, number of treat- felt that the changes after their first treatment were
ments, areas treated, volumes injected, posttreatment minimal and were re-treated; of these, 4 did note
sequellae, and length of follow-up. improvement after the second treatment. No patients

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A B C

Figure 1. Photographs taken before (A) and 3 (B) and 12 (C) months after a single treatment with intradermal and subdermal injection of platelet-rich fibrin matrix
for improvement of the nasolabial folds. Generally, improvement is noted within 2 to 3 weeks. Comparison of the 3- and 12-month views demonstrates stability
and durability of correction over time.

noted any nodules, irregularity, excessive correction, cal application of PRFM. In facial plastic surgery, a clini-
or restriction of movement. cally significant reduction of Wrinkle Assessment Scale
scores was noted after a single intradermal/subdermal in-
COMMENT jection of PRFM into moderate to deep nasolabial folds.
The improvement was noted as early as 2 weeks after treat-
Autologous tissue would be the ideal material choice ment and persisted throughout the 12-week duration of
for soft-tissue augmentation in the face if it could be the study.
provided in a simple process with good predictability. I believe that autologous PRFM produces sustained
Need for tissue harvesting, access incisions, postopera- tissue effects because it more closely mimics the body’s
tive recovery, and often unpredictable graft survival and natural wound-healing response. As opposed to PRP,
longevity have encouraged physicians to consider other PRFM does not rely on extremely high concentrations
available minimally invasive techniques and materials. of platelets and a massive, 1-time release of GFs but rather
These materials, however, may be resorbed, infected, or on providing a more natural, sustained wound re-
associated with a chronic granulomatous response. sponse. It concentrates platelets but not to the extreme
Early attempts to use the patient’s own collagen to pro- degree seen in PRP. Instead, platelets are delivered to the
mote soft-tissue augmentation showed limited persis- tissue accompanied by an actively polymerizing 3-di-
tence.12 Injection of cultured autologous fibroblasts was mensional fibrin mesh. This mesh serves to localize tis-
expensive and time consuming and provided equivocal sue activity because both platelets and their GFs bind to
results.13 it, as in the natural wound. Moreover, platelets in PRFM
Dermal stimulation with exogenous microparticles (eg, in vitro have been shown to continue to synthesize and
poly-L-lactic acid) has been shown to effectively thicken release bioactive GFs over the first 7 days.16 It is this natu-
the dermis. However, the results require multiple treat- ral, sustained GF release that I believe is critical to the
ments, and care must be taken to avoid nodularity and development of the sustained tissue effects. By localiz-
granulomas. Moreover, this technique requires implan- ing platelets and GFs and fostering a physiologic tissue
tation of a foreign body to act as the stimulus for colla- response in the treated area, PRFM produces guided tis-
gen deposition.14 sue regeneration. According to the preliminary results
Ideally, the body’s natural capacity to generate colla- from an ongoing histologic study of skin treated with
gen would be used to create additional bulk. In a study PRFM, new collagen has been identified as early as 7 days
examining the effects of PRP, my colleagues and I noted after treatment, and maturing collagen fibers are still evi-
an early increase in endothelial cells and fibroblasts in a dent at 10 weeks.
wound, which did not persist after 7 days.6 This early effect Platelet-rich fibrin matrix can be used to correct fine
on fibroblasts and endothelial cells, however, spurred our rhytids and deeper folds as well as for facial volumiza-
interest in harnessing the body’s natural mechanisms for tion (Figure 1). It can also be combined with subci-
wound repair and collagen production for use in soft- sion to improve the appearance of rolling acne scars.
tissue augmentation. Two and a half years of clinical experience using PRFM
Platelet-rich fibrin matrix (Selphyl) has been avail- has shown it to be safe and effective, producing rela-
able in the United States for several years and has been tively early clinical improvements with prolonged
used clinically in orthopedic surgical and wound- effect. No patients have seen the total loss of the origi-
healing applications. In a study of chronic, nonhealing nal correction, and only a few have noticed any signifi-
venous leg ulcers, O’Connell et al15 were able to induce cant loss of effect; it is unclear whether this loss of
closure in 66.7% of wounds within 16 weeks with topi- effect represents resorption of new collagen or is simply

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A B

C D

Figure 2. Photographs taken before (A and B) and after (C and D) treatment with platelet-rich fibrin matrix. A and B, Preoperative views of a patient undergoing
external rhinoplasty with tip contouring and grafting in addition to dorsal reduction and bilateral medial, intermediate, and lateral osteotomies. Platelet-rich fibrin
matrix is injected along the intermediate and lateral osteotomy lines immediately before the dorsal cast is applied. C and D, Photographs taken immediately after
removal of the cast and sutures on postoperative day 6 show no ecchymosis and limited edema.

the result of continued aging in these patients. I have improvement after 2 injections, and patients should be
also used PRFM adjunctively during rhytidectomy, rhi- advised that unknown factors (possibly related to their
noplasty (Figure 2), and autologous fat transfer to skin or platelet function) may prevent generation of an
promote wound healing, to limit ecchymosis and adequate response. However, sustained clinical results
edema, and to accelerate angiogenesis and revascular- have been seen over the long term, and PRFM repre-
ization, respectively. No patient has developed any sents the only natural-based method of autologous tis-
irregularity, nodularity, or excessive fibrosis. sue regeneration.
It has also become clear that initial overcorrection is
desirable, as some of the injected volume is related to the Accepted for Publication: December 10, 2010.
plasma volume, which is rapidly resorbed over a 3- to Published Online: February 21, 2011. doi:10.1001
12-hour period. Indeed, initial undercorrection may ex- /archfacial.2011.3
plain why some patients responded clinically to a sec- Correspondence: Anthony P. Sclafani, MD, Division of
ond injection after failing to show clinically significant Facial Plastic and Reconstructive Surgery, The New York
improvement after the initial treatment. It should be noted, Eye and Ear Infirmary, 310 E 14th St, New York, NY
however, that 1 patient failed to show clinically relevant 10003 ([email protected]).

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Author Contributions: Dr Sclafani had full access to all soft tissue ingrowth in synthetic and allogeneic implants with platelet concentrate.
Arch Facial Plast Surg. 2005;7(3):163-169.
the data in the study and takes responsibility for the in-
7. Buckley A, Davidson JM, Kamerath CD, Wolt TB, Woodward SC. Sustained re-
tegrity of the data and the accuracy of the data analysis. lease of epidermal growth factor accelerates wound repair. Proc Natl Acad Sci
Financial Disclosure: Dr Sclafani is a consultant for, and U S A. 1985;82(21):7340-7344.
has received research support from, Aesthetic Factors. 8. Sclafani AP. Applications of platelet-rich fibrin matrix in facial plastic surgery.
Previous Presentation: This study was presented in part Facial Plast Surg. 2009;25(4):270-276.
at the Annual Meeting of the American Academy of Fa- 9. Sclafani AP. Platelet-rich fibrin matrix for improvement of deep nasolabial folds.
J Cosmet Dermatol. 2010;9(1):66-71.
cial Plastic and Reconstructive Surgery; September 24,
10. Azzena B, Mazzoleni F, Abatangelo G, Zavan B, Vindigni V. Autologous platelet-
2010; Boston, Massachusetts. rich plasma as an adipocyte in vivo delivery system: case report. Aesthetic Plast
Surg. 2008;32(1):155-161.
REFERENCES 11. Cervelli V, Gentile P. Use of platelet gel in Romberg syndrome. Plast Reconstr
Surg. 2009;123(1):22e-23e.
12. Sclafani AP, Romo T III, Parker A, McCormick SA, Cocker R, Jacono A. Autolo-
1. Papanas N, Maltezos E. Benefit-risk assessment of becaplermin in the treatment
gous collagen dispersion (Autologen) as a dermal filler: clinical observations and
of diabetic foot ulcers. Drug Saf. 2010;33(6):455-461.
histologic findings. Arch Facial Plast Surg. 2000;2:48-52.
2. Beaven AW, Shea TC. The effect of palifermin on chemotherapyand radiation
therapy-induced mucositis: a review of the current literature. Support Cancer Ther. 13. Watson D, Keller GS, Lacombe V, Fodor PB, Rawnsley J, Lask GP. Autologous
2007;4(4):188-197. fibroblasts for treatment of facial rhytids and dermal depressions: a pilot study.
3. Hom DB. New developments in wound healing relevant to facial plastic surgery. Arch Facial Plast Surg. 1999;1(3):165-170.
Arch Facial Plast Surg. 2008;10(6):402-406. 14. Mest DR, Humble G. Safety and efficacy of poly-L-lactic acid injections in per-
4. Powell DM, Chang E, Farrior EH. Recovery from deep-plane rhytidectomy fol- sons with HIV-associated lipoatrophy: the US experience. Dermatol Surg. 2006;
lowing unilateral wound treatment with autologous platelet gel: a pilot study. Arch 32(11):1336-1345.
Facial Plast Surg. 2001;3(4):245-250. 15. O’Connell SM, Impeduglia T, Hessler K, Wang XJ, Carroll RJ, Dardik H. Autolo-
5. Danielsen P, Jørgensen B, Karlsmark T, Jorgensen LN, Agren MS. Effect of topi- gous platelet-rich fibrin matrix as cell therapy in the healing of chronic lower-
cal autologous platelet-rich fibrin versus no intervention on epithelialization of extremity ulcers. Wound Repair Regen. 2008;16(6):749-756.
donor sites and meshed split-thickness skin autografts: a randomized clinical 16. Carroll RJ, Arnoczky SP, Graham S, O’Connell SM. Characterization of Autolo-
trial. Plast Reconstr Surg. 2008;122(5):1431-1440. gous Growth Factors in Cascade Platelet-Rich Fibrin Matrix (PRFM). Edison, NJ:
6. Sclafani AP, Romo T III, Ukrainsky G, et al. Modulation of wound response and Musculoskeletal Transplant Foundation; 2005.

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