Changing the Paradigm of Craniofacial Reconstruction: A Prospective Clinical Trial of Autologous Fat Transfer for Craniofacial Deformities.

OBJECTIVE: This study aimed to prospectively assess outcomes for surgical autologous fat transfer (AFT) applied for traumatic and postsurgical craniofacial deformities. The minimally invasive nature of AFT has potential for reduced risk and superior outcomes compared with current reconstructive options. BACKGROUND: Craniofacial deformities have functional and psychosocial sequelae and can profoundly affect quality of life. Traditional reconstructive options are invasive, invasive, complex, and often lack precision in outcomes. Although AFT is safe, effective, and minimally invasive, only anecdotal evidence exists for reconstruction of craniofacial deformities. METHODS: In this Institutional Review Board-approved prospective cohort study, 20 subjects underwent AFT (average volume: 23.9 ±â€Š13.2 mL). Volume retention over time was determined using high-resolution computed tomography. Flow cytometry was used to assess cellular subpopulations and viability in the stromal vascular fraction. Quality of life assessments were performed. After the completion of 9-month follow-up, 5 subjects were enrolled for a second treatment. RESULTS: No serious adverse events occurred. Volume retention averaged 63 ±â€Š17% at 9 months. Three-month retention strongly predicted 9-month retention (r=0.996, P < 0.0001). There was no correlation between the total volume injected and retention. Patients undergoing a second procedure had similar volume retention as the first (P = 0.05). Age, sex, body mass index, and stromal vascular fraction cellular composition did not impact retention. Surprisingly, former smokers had greater volume retention at 9 months compared with nonsmokers (74.4% vs 56.2%, P = 0.009). Satisfaction with physical appearance (P = 0.002), social relationships (P = 0.02), and social functioning quality of life (P = 0.05) improved from baseline to 9 months. CONCLUSIONS: For craniofacial defects, AFT is less invasive and safer than traditional reconstructive options. It is effective, predictable, and reaches volume stability at 3 months. Patient-reported outcomes demonstrate a positive life-changing impact.

Regen Fat Code: A Standardized Protocol for Facial Volumetry and Rejuvenation.

BACKGROUND: Facial aging is a degenerative process that impairs contour and angle prominence. Rejuvenation is based on tissue replacement, volumization of the atrophic areas, and improving flaccidity and cutaneous photoaging. OBJECTIVES: The aim of this study was to apply structural fat grafting to manage volumetric deficits of the face, following a new systematic protocol called "Regen Fat Code" (RF Code) that was created to standardize structural lipotransfer methods. METHODS: This is a prospective clinical trial involving 80 healthy candidates for facial rejuvenation who were split into 2 groups. Group A underwent only structural lipotransfer; Group B underwent replacement of deep facial structures by face-lifting plus structural lipotransfer. Structural lipotransfer followed the protocol "RF Code" and 3 clinical tools were adopted for pre- and postoperative facial volumetric analysis. RESULTS: Total volume (mL) of lipotransfer in Groups A and B ranged between 1 and 20 mL (mean [standard deviation], 12 [5] mL), distributed to the different areas as follows: nasolabial fold, 3.32 [0.92] mL; superior lip, 2.0 [0.62] mL; inferior lip, 2.76 [0.71] mL; malar, 8.51 [5.25] mL; inferior eyelid, 1.2 [0.54] mL; and chin, 7.18 [1.99] mL. Areas with less mobility showed a lower absorption index than dynamic areas. CONCLUSIONS: The development of the RF Code protocol demonstrated the potential of grouping many parameters based on the lipotransfer method used to volumize and regenerate atrophic areas of the face. The protocol is easy to apply, and allows different volumizing and regenerative effects to be proposed, according to the demands of each surgical area.

Long-Term Survival of Fat Transplants: Controlled Demonstrations.

To document the amount and rate of re-absorption of fatty tissue transplanted using the author's technique, the author initiated controlled studies in 1987. A selected crease was infiltrated with autologous fatty tissue using a nearby crease as control. At specific time intervals the infiltrated crease was compared to the nearby control crease to evaluate percentage of recurrence. Photographs were taken in the first week, then at least yearly over six years. All views, all positions of the mouth, and all lighting situations demonstrated the continued absence of any crease in the area of infiltration. In contrast, the nearby control crease remained unchanged or deepened from its preoperative condition, giving every indication of a permanent correction. This experiment demonstrates the potential lasting nature of corrections performed with the transplantation of fatty tissue and is supported by over 400 infiltrations into the nasolabial folds in the author's practice.

Current Fat Grafting Practices and Preferences: A Survey from Members of ISPRES.

Fat grafting has established its niche in a wide spectrum of aesthetic and reconstructive procedures. A consensus-based method of harvest, processing, enrichment, injection, and assessment is lacking, despite the rising trends in its application. We conducted a survey among plastic surgeons to evaluate and identify trends of fat grafting practices. Methods: We conducted an electronic survey with a 30-item questionnaire of 62 members of the International Society of Plastic Regenerative Surgeons. We collected demographic information, techniques, and experiences related to large volume (100-200 ml) and small-volume (<100 ml) fat grafting. Results: The majority of the respondents worked predominantly as aesthetic surgeons. The donor area selection was based on the patient's fat availability (59.7%). For fat enrichment, platelet-rich-plasma and adipose stem cells were routinely used by 12.9% and 9.7% of respondents, respectively. A 3- to 4-mm cannula with three holes was the most preferred instrument for large-volume fat harvesting (69.5%). For small-volume fat grafting, 2-mm cannulas (75.8%) with Mercedes tip (27.3%) were used most commonly. For processing, decantation of fat was performed by 56.5% of respondents (without exclusivity). For handheld injections (without exclusivity), respondents preferred a 1- to 2-mm cannula with a 1 cm3 syringe. The most popular method of outcome assessment was photographic evaluation. Conclusions: The respondents' tendencies were similar to those reported in the previous literature, with some exceptions, such as the technique for preparing fat and enrichment. A wider cross-sectional survey, involving national delegates and global representatives of plastic surgeons, is anticipated.

Stem Cell Therapy Enriched Fat Grafting for the Reconstruction of Craniofacial Deficits.

Fat grafting is an effective treatment for craniofacial deformities. Stromal vascular fraction (SVF) is a concentrated form of adipose derived stem cells that can be isolated from fat. The aim of this clinical trial was to assess the impact of SVF enrichment on craniofacial fat grafting. Methods: Twelve subjects with at least two regions of craniofacial volume deficit were enrolled, and they underwent fat grafting with SVF-enriched or standard fat grafting to each area. All patients had bilateral malar regions injected with SVF-enriched graft on one side and control standard fat grafting to the contralateral side. Outcome assessments included demographic information, volume retention determined by CT scans, SVF cell populations assessed by flow cytometry, SVF cell viability, complications, and appearance ratings. Follow-up was 9 months. Results: All patients had improvement in appearance. There were no serious adverse events. There was no significant difference in volume retention between the SVF-enriched and control regions overall (50.3% versus 57.3%, P = 0.269) or comparing malar regions (51.4% versus 56.7%, P = 0.494). Patient age, smoking status, obesity, and diagnosis of diabetes did not impact volume retention. Cell viability was 77.4% ± 7.3%. Cellular subpopulations were 60.1% ± 11.2% adipose derived stem cells, 12.2 ± 7.0% endothelial cells, and 9.2% ± 4.4% pericytes. A strong positive correlation was found between CD146+ CD31-pericytes and volume retention (R = 0.863, P = 0.027). Conclusions: Autologous fat transfer for reconstruction of craniofacial defects is effective and safe, leading to reliable volume retention. However, SVF enrichment does not significantly impact volume retention.

Evolution of the Coleman Technique.

SUMMARY: Fat grafting is one of the most revolutionary surgical techniques of our century, and it has changed the field of plastic surgery and regenerative medicine. Early reports of fat grafting date back to the late nineteenth century, but the results were unsatisfactory because of minimal graft retention. It was not until Sydney R. Coleman challenged the dogma and introduced a standardized approach to fat grafting after years of research and learning from experts across the world. The Coleman technique represents an evolutionary approach to fat grafting, with three main components: harvesting, refinement, and placement. The Coleman technique has been adopted and modified by surgeons around the world because it has allowed a reliable increase in fat graft survival through a standardized process. This article discusses the influencing factors and milestones that led to this world-known technique, in addition to Dr. Coleman's current practices, pearls, pitfalls, and lessons learned over the years. The knowledge of the true potential and usefulness of fat is in its infancy, with its regenerative potential becoming increasingly recognized. Current and future research will likely prove that autologous fat has many clinical applications beyond its well-known aesthetic and reconstructive benefits and extending beyond the regenerative realm.

Fat Grafting in Radiation-Induced Soft-Tissue Injury: A Narrative Review of the Clinical Evidence and Implications for Future Studies.

SUMMARY: Radiation-induced changes in skin and soft tissue result in significant cosmetic and functional impairment with subsequent decrease in quality of life. Fat grafting has emerged as a therapy for radiation-induced soft-tissue injury, and this narrative review aims to evaluate the current clinical evidence regarding its efficacy. A review was conducted to examine the current clinical evidence of fat grafting as a therapy for radiation-induced injury to the skin and soft tissue and to outline the clinical outcomes that can be used to more consistently quantify chronic radiation-induced injury in future clinical studies. The current clinical evidence regarding the efficacy of fat grafting to treat radiation-induced injury of the skin and soft tissue suggests that fat grafting increases skin softness and pliability, induces volume restoration, improves hair growth in areas of alopecia, reduces pain, and improves cosmetic and functional outcomes. However, literature in this field is far from robust and mired by the retrospective nature of the studies, lack of adequate controls, and inherent limitations of small case series and cohorts. A series of actions have been identified to strengthen future clinical data, including the need for physical examination using a validated scale, appropriate imaging, skin biomechanics and microcirculation testing, and histologic analysis. In conclusion, radiation-induced soft-tissue injury is a significant health burden that can lead to severe functional and aesthetic sequelae. Although still in a preliminary research phase, there is promising clinical evidence demonstrating the benefits of fat grafting to treat chronic changes after radiation therapy. Future clinical studies will require larger cohorts, adequate controls, and consistent use of objective measurements.

Cryopreservation of autologous fat grafts harvested with the Coleman technique.

The viability of fat grafts harvested with an established technique after cryopreservation remains unknown. This study was conducted in vitro to evaluate the viability of autologous fat grafts harvested with the Coleman technique and subsequently preserved with our preferred cryopreservation method. Eight adult females were enrolled in this study. In each patient, 10 mL of fat grafts were harvested with the Coleman technique by a single surgeon from the lower abdomen. In group 1, 5 mL of fresh fat grafts were mixed with cryoprotective agents and underwent cryopreservation with controlled slow cooling and fast rewarming. In group 2, 5 mL of fresh fat grafts without cryopreservation from the same patient served as a control. The fat graft samples from both groups were evaluated with trypan blue vital staining, glycerol-3-phophatase dehydrogenase assay, and routine histology. Viable adipocyte counts were found similar in both group 1 and group 2 (3.46 +/- 0.91 vs. 4.12 +/- 1.11 x 10/mL, P = 0.22). However, glycerol-3-phophatase dehydrogenase activity was significantly lower in group 1 compared with group 2 (0.47 +/- 0.09 vs. 0.66 +/- 0.09 u/mL, P < 0.001). Histologically, the normal structure of fragmented fatty tissues was found primarily in both groups. Our results indicate that autologous fat grafts harvested with the Coleman technique and preserved with our preferred cryopreservation method have a normal histology with near the same number of viable adipocytes as compared with the fresh fat grafts. However, those cryopreserved fat grafts appear to have a less optimal level of adipocyte specific enzyme activity compared with the fresh ones and thus may not survive well after they are transplanted without being optimized.

Facial Fat Grafting: The Past, Present, and Future.

Fat grafting has evolved over the past two centuries and has revolutionized regenerative medicine, aesthetic and reconstructive surgery. Fat grafting provides a safe and minimally invasive technique to improve signs of aging, sun damage, and congenital and acquired craniofacial deformities. The Coleman technique for harvesting, processing, and grafting provides a reliable strategy for consistent results. However, unanswered questions remain regarding the biology of fat grafting, survival mechanisms, and regenerative properties. The future of fat grafting is bright and includes cell-based therapy and extracellular matrix-based scaffolds. This article provides an overview of the past, present, and future of facial fat grafting.

Fat Grafting for Treatment of Secondary Facial Deformity.

Craniofacial deformities represent a great challenge for the patient and the plastic surgeon. Fat grafting has allowed a shift in paradigm for craniofacial reconstruction by providing a less invasive and safer alternative than traditional reconstructive options. Increasing evidence supports its use with optimal results. This article examines the evidence and practical aspects involved in the decision making and technique of fat grafting to treat secondary craniofacial deformities.

Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves.

BACKGROUND: Cryolipolysis provides a method for noninvasive fat reduction that significantly reduces subcutaneous fat in a pig model without apparent damage to skin and surrounding structures. This study aimed to determine whether fat reduction in humans caused by cold exposure is associated with alteration in local sensory function or nerve fibers. METHODS: In this study, 10 subjects were treated with a prototype cooling device. Fat reduction was assessed in 9 of the 10 subjects via ultrasound before treatment and at the follow-up visit. Sensory function was assessed by neurologic evaluation (n = 9), and biopsies (n = 1) were collected for nerve staining. RESULTS: Treatment resulted in a normalized fat layer reduction of 20.4% at 2 months and 25.5% at 6 months after treatment. Transient reduction in sensation occurred in six of nine subjects assessed by neurologic evaluation. However, all sensation returned by a mean of 3.6 weeks after treatment. Biopsies showed no long-term change in nerve fiber structure. There were no lasting sensory alterations or observations of skin damage in any of the subjects evaluated. CONCLUSION: Noninvasive cryolipolysis results in substantial fat reduction within 2 months of treatment without damage to skin. The procedure is associated with modest reversible short-term changes in the function of peripheral sensory nerves.

The Role of Fat Grafting in Alleviating Neuropathic Pain: A Critical Review of the Literature.

BACKGROUND: Neuropathic pain is one of the more severe types of chronic pain and presents a great challenge as response to medical therapy remains often unpredictable. With the opioid epidemic and the search for ways to avoid narcotics, physicians are seeking other modalities to treat neuropathic pain. In recent years, surgeons have explored various surgical avenues to improve outcomes. The aim of this review was to evaluate the current clinical evidence regarding the efficacy of fat grafting for the treatment of neuropathic pain. METHODS: A critical review was conducted to examine the current clinical evidence of fat grafting as a therapy for neuropathic pain caused by neuromas, peripheral neuralgia, migraine and headaches, neuropathic scar pain, and postmastectomy pain syndrome. RESULTS: The precise mechanism role of fat grafting in modulating neuropathic pain remains unclear, but it appears to reduce pain levels through the anti-inflammatory effects of adipose-derived stem cells and mechanical cushioning by fat. CONCLUSIONS: Fat grafting is an emerging therapy for chronic neuropathic pain of various etiologies. Although promising results have been reported, sample size and level of evidence of current studies are low. The encouraging results, however, are worthy of further clinical and scientific study. The minimally invasive nature of fat grafting and favorable risk profile make this an attractive therapy for neuropathic pain.

Fat Grafting for Improved Ileostomy Ostomy Device Fit: A Case Report.

For patients with an ostomy, a poor fitting appliance may cause leakage, peristomal dermatitis, and frequent appliance changes. PURPOSE: The purpose of this case study was to report the outcome of fat grafting to augment peristomal soft tissue and improve appliance fit. CASE STUDY: A 57-year-old woman with a history of Crohn's disease presented with soft-tissue deficiency and uneven contour around her ileostomy site. She was unable to properly fit an ostomy appliance, which resulted in leakage, chronic skin irritation, and frequent appliance changes. The patient underwent 2 rounds of fat grafting using fat harvested from her medial thighs and knees infused with dilute lidocaine with epinephrine. The patient noted immediate improvement after 34 cc of processed fat was injected in the first round. Appliance change frequency decreased from daily to every 3 to 4 days. A second graft of 32 cc provided 3 months later further improved appliance fit, reducing appliance change frequency to every 5 to 7 days and obviating the need to use adjustment rings and glue. Pre- and postoperative computed tomography showed increased thickness of abdominal wall subcutaneous tissues. CONCLUSION: Fat grafting around an ostomy site presents a viable option to improve contour and appliance fit with reduced skin irritation and leakage.

Injectable Allograft Adipose Matrix Supports Adipogenic Tissue Remodeling in the Nude Mouse and Human.

BACKGROUND: Adipose tissue reaches cellular stasis after puberty, leaving adipocytes unable to significantly expand or renew under normal physiologic conditions. This is problematic in progressive lipodystrophies, in instances of scarring, and in soft-tissue damage resulting from lumpectomy and traumatic deformities, because adipose tissue will not self-renew once damaged. This yields significant clinical necessity for an off-the-shelf de novo soft-tissue replacement mechanism. METHODS: A process comprising separate steps of removing lipid and cellular materials from adipose tissue has been developed, creating an ambient temperature-stable allograft adipose matrix. Growth factors and matrix proteins relevant to angiogenesis and adipogenesis were identified by enzyme-linked immunosorbent assay and immunohistochemistry, and subcutaneous soft-tissue integration of the allograft adipose matrix was investigated in vivo in both the athymic mouse and the dorsum of the human wrist. RESULTS: Allograft adipose matrix maintained structural components and endogenous growth factors. In vitro, adipose-derived stem cells cultured on allograft adipose matrix underwent adipogenesis in the absence of media-based cues. In vivo, animal modeling showed vasculature formation followed by perilipin A-positive tissue segments. Allograft adipose matrix maintained soft-tissue volume in the dorsal wrist in a 4-month investigation with no severe adverse events, becoming palpably consistent with subcutaneous adipose. CONCLUSIONS: Subcutaneous implantation of allograft adipose matrix laden with retained angiogenic and adipogenic factors served as an inductive scaffold for sustaining adipogenesis. Tissue incorporation assessed histologically from both the subcutaneous injection site of the athymic nude mouse over 6 months and human dorsal wrist presented adipocyte morphology residing within the injected scaffold.

Amputation-Site Soft-Tissue Restoration Using Adipose Stem Cell Therapy.

Soft-tissue deficits in amputation stumps can lead to significant pain and disability. An emerging treatment option is stem cell-enriched fat grafting. This is the first study assessing the potential for this treatment modality in lower extremity amputation sites. In this prospective cohort study, five injured military personnel suffering from pain and limited function at amputation sites were recruited. Fat grafting enriched with stromal vascular fraction was performed at amputation sites to provide additional subcutaneous tissue padding over bony structures. Outcomes measures included complications, demographic data, physical examination, cellular subpopulations, cell viability, graft volume retention, pain, Lower Extremity Functional Scale, Functional Mobility Assessment, 36-Item Short-Form Health Survey, and rates of depression. Follow-up was 2 years. There were no significant complications. Volume retention was 61.5 ± 24.0 percent. Overall cell viability of the stromal vascular fraction was significantly correlated with volume retention (p = 0.016). There was no significant correlation between percentage of adipose-derived stem cells or number of cells in the stromal vascular fraction and volume retention. There was a nonsignificant trend toward improvement in pain scores (3.0 ± 2.5 to 1.2 ± 1.6; p = 0.180 at 2 years). There were no significant changes in disability indexes. Results from this pilot study demonstrate that stromal vascular fraction-enriched fat grafting is a safe, novel modality for the treatment of symptomatic soft-tissue defects in traumatic lower extremity amputations. Volume retention can be anticipated at slightly over 60 percent. Further studies are needed to assess efficacy. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, IV.

Regulatory Advocacy Update: American Society of Plastic Surgeons Comments in Response to the U.S. Food and Drug Administration Draft Guidance Documents on Human Cell and Tissue Products.

The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.

Facial augmentation with structural fat grafting.

Fat grafting through a blunt cannula has been used by plastic surgeons for altering facial contours for 100 years. Autologous tissue is completely biocompatible and is usually the safest choice for altering facial volume or contours. Fat grafts can be placed in such a fashion that they are long lasting, completely integrated, and natural appearing. Only in the past 20 years have advances in techniques and instrumentation allowed us to obtain predictable results that make fat grafting a viable option for soft tissue augmentation. Our understanding of aging and methods of rejuvenation have developed also. We now approach rejuvenation and adjustment of facial proportion with a better understanding of the need for the restoration or adjustment of facial volume.

The anatomy of the aging face: volume loss and changes in 3-dimensional topography.

Facial aging reflects the dynamic, cumulative effects of time on the skin, soft tissues, and deep structural components of the face, and is a complex synergy of skin textural changes and loss of facial volume. Many of the facial manifestations of aging reflect the combined effects of gravity, progressive bone resorption, decreased tissue elasticity, and redistribution of subcutaneous fullness. A convenient method for assessing the morphological effects of aging is to divide the face into the upper third (forehead and brows), middle third (midface and nose), and lower third (chin, jawline, and neck). The midface is an important factor in facial aesthetics because perceptions of facial attractiveness are largely founded on the synergy of the eyes, nose, lips, and cheek bones (central facial triangle). For aesthetic purposes, this area should be considered from a 3-dimensional rather than a 2-dimensional perspective, and restoration of a youthful 3-dimensional facial topography should be regarded as the primary goal in facial rejuvenation. Recent years have seen a significant increase in the number of nonsurgical procedures performed for facial rejuvenation. Patients seeking alternatives to surgical procedures include those who require restoration of lost facial volume, those who wish to enhance normal facial features, and those who want to correct facial asymmetry. Important factors in selecting a nonsurgical treatment option include the advantages of an immediate cosmetic result and a short recovery time.