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Background: The past few years have seen a 50% increase in breast implant explantations. Patients with ptotic breasts may desire mastopexy, although conventional techniques are often invasive. We describe our experience with the omega mastopexy technique after breast implant explantation and capsulectomy. Methods: In the past 2 years, 10 patients with breast Regnault classification ptosis grade I-III underwent the omega mastopexy technique following breast implant explantation and capsulectomy. A detailed description of our operating technique is provided. Results: This series includes a total of 10 patients. The median age was 48.5 (IQR 42.8-52.5), median body mass index 26 (23.8-28.3) and median implant volume 355 (IQR 325-375). Excellent and stable aesthetic results were achieved without recurring ptosis. One patient, an active smoker, underwent reexcision after 1 year due to hypertrophic scars. No complications have been reported until this date at 2 years follow-up. Conclusions: The omega mastopexy technique offers an excellent alternative to classic lifting techniques for ptotic breasts after breast implant explantation. Patients with increased risk of wound healing impairment are especially likely to benefit.
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Background: The posterior Müller muscle-conjunctival resection (MMCR) procedure is a straightforward procedure for the correction of eyelid ptosis with a relatively short operating time and fast recovery. Traditionally, its use was limited to patients with mild involutional ptosis and good levator function and a positive phenylephrine test result. Objectives: To evaluate the efficacy of the MMCR procedure as a primary step to treat eyelid ptosis with varying etiology and severity, including patients with more severe ptosis and moderate levator function, and to produce a treatment algorithm. Methods: A retrospective analysis of the results of 34 patients, comprising 56 operated eyelids, treated with the MMCR procedure for eyelid ptotis between 2016 and 2018, was performed. Preoperative and postoperative pictures were analyzed for determining the margin-to-reflex distance (MRD1), symmetry, and complications. Results: We found a mean preoperative MRD1 of 1.3â mm (SD 1.1) and postoperative MRD1 of 3.2â mm (SD 1.0). The mean postoperative MRD1 for unilateral and bilateral cases was 3.4 (SD 0.8) and 3.2 (SD 1.1), respectively. Only 2 patients (5.9%) had an asymmetrical postoperative result (>1.0â mm MRD1 difference), and both were unilateral cases. Complications were scarce: only 1 patient (2.9%) developed dry eyes and 2 patients experienced temporary discomfort from the conjunctival sutures. Conclusions: The MMCR procedure appears to be an excellent procedure as a primary step to correct eyelid ptosis with varying etiologies and severity, due to its low risk of asymmetry, short learning curve, and high success rate. A flow chart as treatment algorithm is provided for clinical decision making.
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BACKGROUND: The soft tissue glideplanes of the face are functionally important and have a role in facial rejuvenation surgery. The aim of this study was to improve our understanding of soft tissue mobility of the face and its impact on the redraping of tissues involved in facelifting. The consequences of "no-release" and "extensive-release" lifting were analyzed to explain the difference in efficacy and potential longevity between these two contrasting philosophies. MATERIALS METHODS: Preliminary dissections and macro sectioning were followed by a definitive series of standardized layered dissections on fifty cadaver heads, along with histology, sheet plastination, and mechanical testing. RESULTS: The previously described spaces are potential surgical dissection planes deep to the superficial fascia layer. The classically described retaining ligaments are local reinforcements of a system of small retaining fibers (retinacula cutis and deep retinacula fibers) which provide support of the soft tissues of the face and neck against gravitational sagging while allowing certain mobility. This mobility is utilized when mobile tissues are lifted without surgical release. However, the process of dragging up these fibers results in a loss of their previous, anti-gravitational, supportive orientation. CONCLUSION: No-release lifting techniques, such as thread lifts and minimal-invasive facelifts, tighten "tissue laxity" with a change of the gravity-opposing tissue architecture, placing the weight of the flap solely on the fixation, which limits longevity of the lift. The alternative, to perform a full release with redraping, enables reattachment of the flap to a higher position, with preservation of the original deep fascial architecture with its antigravity orientation and natural mobility, conceivably improving the longevity of the lift.
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Implante Mamário , Implantes de Mama , Mamoplastia , Cirurgiões , Cirurgia Plástica , Humanos , Inquéritos e Questionários , MastectomiaRESUMO
BACKGROUND: A limitation of current facelift techniques is the early postoperative reappearance of anterior midcheek laxity associated with recurrence of the nasolabial fold (NLF). OBJECTIVES: This study was undertaken to examine the regional anatomy of the anterior midcheek and NLF with a focus on explaining the early recurrence phenomenon and to explore the possibility of alternative surgical methods that prolong NLF correction. METHODS: Fifty cadaver heads were studied (16 embalmed, 34 fresh; mean age, 75 years). Following preliminary dissections and macrosectioning, a series of standardized layered dissections were performed, complemented by histology, sheet plastination, and microcomputed tomography. Mechanical testing of the melo fat pad (MFP) and skin was performed to gain insight on which structure is responsible for transmission of the lifting tension in a composite facelift procedure. RESULTS: Anatomic dissections, sheet plastination, and microcomputed tomography demonstrated the 3-dimensional architecture and borders of the MFP. Histology of a lifted midcheek demonstrated that a composite MFP lift causes a change in connective tissue organization from a hanging-down pattern into a pulled-upward pattern, suggesting traction on the skin. Mechanical testing confirmed that, in a composite lift, despite the sutures being placed directly into the deep aspect of the MFP, the lifting tension distal to the suture is transmitted through the skin and not through the MFP. CONCLUSIONS: The usual method of performing a composite midcheek lift results in the skin, and not the MFP itself, bearing the load of the nondissected tissues distal to the lifting suture. For this reason, early recurrence of the NLF occurs following skin relaxation in the postoperative period. Accordingly, specific surgical procedures for remodeling the MFP should be explored, possibly in combination with volume restoration of the fat and bone, for more lasting improvement of the NLF.
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Sulco Nasogeniano , Ritidoplastia , Idoso , Humanos , Tecido Adiposo/cirurgia , Sulco Nasogeniano/cirurgia , Ritidoplastia/métodos , Microtomografia por Raio-XRESUMO
BACKGROUND: Despite the central role of the platysma in face and neck rejuvenation, much confusion exists regarding its surgical anatomy. OBJECTIVES: This study was undertaken to clarify the regional anatomy of the platysma and its innervation pattern and to explain clinical phenomena, such as the origin of platysmal bands and their recurrence, and the etiology of lower lip dysfunction after neck lift procedures. METHODS: Fifty-five cadaver heads were studied (16 embalmed, 39 fresh, mean age 75 years). Following preliminary dissections and macro-sectioning, a series of standardized layered dissections were performed, complemented by histology and sheet plastination. RESULTS: In addition to its origin and insertion, the platysma is attached to the skin and deep fascia across its entire superficial and deep surfaces. This composite system explains the age-related formation of static platysmal bands, recurrent platysmal bands after complete platysma transection, and recurrent anterior neck laxity after no-release lifting. The facial part of the platysma is primarily innervated by the marginal mandibular branch of the facial nerve, whereas the submandibular platysma is innervated by the "first" cervical branches, which terminate at the mandibular origin of the depressor labii inferioris. This pattern has implications for postoperative dysfunction of the lower lip, including pseudoparalysis, and potential targeted surgical denervation. CONCLUSIONS: This anatomical study, comprised of layered dissections, large histology, and sheet plastination, fully describes the anatomy of the platysma including its bony, fascial, and dermal attachments, as well as its segmental innervation including its nerve danger zones. It provides a sound anatomical basis for the further development of surgical techniques to rejuvenate the neck with prevention of recurrent platysmal banding.
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Ritidoplastia , Sistema Musculoaponeurótico Superficial , Humanos , Idoso , Ritidoplastia/efeitos adversos , Ritidoplastia/métodos , Lábio/cirurgia , Rejuvenescimento , Sistema Musculoaponeurótico Superficial/inervação , Pescoço/cirurgiaRESUMO
INTRODUCTION: The deep fascia is important in facelift surgery as it is relied on for protection of the facial nerve during surgical dissection. Lack of consistency with the term may be due to the term deep fascia having two different meanings. It is a specific type of connective tissue, classically, thin, fibrous and flat. Whereas, in the description of the layers of the face and neck, the deep fascia layer includes all the connective tissue deep to the superficial fascia layer. This cadaver study was undertaken to clarify the layered anatomy of the face and neck and its relationship with the facial nerve branches. MATERIALS METHODS: Preliminary dissections and macro sectioning, followed by a conclusive series of standardized layered dissections, histology and sheet plastination, was performed on fifty cadaver heads. RESULTS: The deep fascia is thin in convex areas of the face and neck, while thicker in concave areas, it being interspersed with deep fat. The facial nerve branches, after emerging from the parotid gland, are embedded within the deep fascia, not deep to it. They transition from deep within the deep fascia at specific locations to course in the most superficial part of the deep fascia where they underlie their target superficial fascia muscles and are at risk from deep plane facelift dissection. CONCLUSION: The deep fascia layer is a multilamellar fibrofatty layer of variable thickness, which includes the deep fat in which the facial nerve branches are embedded. In deep plane facelift surgery, dissection must be performed in the most superficial level of this deep fascia layer. LEVEL OF EVIDENCE: No level of evidence is needed for Cadaver Study Articles.
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INTRODUCTION: The exact anatomic entity behind the term superficial musculoaponeurotic system (SMAS) remains poorly understood. The different interpretations of the term SMAS by anatomists, surgeons and histologists have caused confusion. This study aims to provide clarity regarding this term and the relevant anatomy. MATERIALS METHODS: A literature review was conducted to uncover the variety of descriptions of the term SMAS. A feasibility study, followed by a conclusive series of standardized layered dissections, complemented by histology and sheet plastination was performed on fifty cadaver heads (16 embalmed, 34 fresh, mean age 75 years). RESULTS: Most literature considers the SMAS as layer 3, i.e., a musculoaponeurotic layer that separates the subcutaneous fat of the superficial fascia from the deep fat of the deep fascia. Our dissections, histology and sheet plastination demonstrated that a layer 3 is present only where there are flat mimetic muscles and platysma-auricular fascia over the posterior part of the parotid gland as the evolutionary remnant of the platysma, but not between the flat mimetic muscles. Here, the subcutaneous fat is in direct contact with the deep fat without the interposition of a musculo-aponeurotic layer 3. CONCLUSION: Due to the absence of a distinct and complete layer 3 connecting the flat mimetic muscles, we conclude that the SMAS as originally concepted does not exist as a specific anatomical entity. In retrospect, the surgically created compound layered flap composed of a variable thickness of subcutaneous fat, mimetic muscles (platysma, orbicularis oculi, ), and a thin layer of deep fascia, is what is known as the "SMAS". LEVEL OF EVIDENCE: No level of evidence is needed for Cadaver Study Articles.
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BACKGROUND: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and its association with macrotextured breast implants may have induced plastic surgeons to change their breast augmentation and breast reconstruction practice. OBJECTIVES: The aim of this study was to survey Dutch plastic surgeons about the effects of BIA-ALCL on their choice of breast implant texture and placement technique. METHODS: An online questionnaire was distributed to all members of the Dutch Association of Plastic Surgeons. Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data. RESULTS: A total of 63 plastic surgeons completed the questionnaire. The majority of respondents altered their use of textured implants due to BIA-ALCL concerns for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). Microtextured and smooth/nanotextured breast implants are now most frequently used. BIA-ALCL did not influence the placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction. CONCLUSIONS: BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery. Breast implant placement technique has not been affected.
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Implante Mamário , Implantes de Mama , Neoplasias da Mama , Linfoma Anaplásico de Células Grandes , Cirurgiões , Humanos , Feminino , Implantes de Mama/efeitos adversos , Linfoma Anaplásico de Células Grandes/epidemiologia , Linfoma Anaplásico de Células Grandes/etiologia , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Inquéritos e QuestionáriosRESUMO
In recent decades, adipose tissue transplantation has become an essential treatment modality for tissue (volume) restoration and regeneration. The regenerative application of adipose tissue has only recently proven its usefulness; for example, the method is useful in reducing dermal scarring and accelerating skin-wound healing. The therapeutic effect is ascribed to the tissue stromal vascular fraction (tSVF) in adipose tissue. This consists of stromal cells, the trophic factors they secrete and the extracellular matrix (ECM), which have immune-modulating, pro-angiogenic and anti-fibrotic properties. This concise review focused on dermal regeneration using the following adipose-tissue components: adipose-tissue-derived stromal cells (ASCs), their secreted trophic factors (ASCs secretome), and the ECM. The opportunities of using a therapeutically functional scaffold, composed of a decellularized ECM hydrogel loaded with trophic factors of ASCs, to enhance wound healing are explored as well. An ECM-based hydrogel loaded with trophic factors combines all regenerative components of adipose tissue, while averting the possible disadvantages of the therapeutic use of adipose tissue, e.g., the necessity of liposuction procedures with a (small) risk of complications, the impossibility of interpatient use, and the limited storage options.
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Abdominoplasty is a widely utilized cosmetic surgery procedure. Despite its popularity, seroma formation remains a prevalent complication. Seroma can lead to extended recovery time, increased medical appointments, and the potential for infection or the need for additional surgical revision. Preserving Scarpa's fascia may mitigate the risk of seroma in patients following abdominoplasty. The goal of this systematic review was to determine the impact of preserving Scarpa's fascia on the occurrence of seroma and total drain output following an abdominoplasty procedure. This review searched academic literature in MEDLINE (via PubMed), EMBASE (OvidSP), and the Cochrane Central Register of Controlled Trials (CENTRAL) for clinical and observational studies published in peer-reviewed journals, from March 2022 to November 2022, that evaluated the impact of preserving Scarpa's fascia on postoperative seroma and total drain output during abdominoplasty. The primary outcomes of interest were seroma and total drain output, with secondary outcomes of interest including hematoma, time to drain removal, length of hospital stay, wound dehiscence, and infection rate. The systematic review of 8 studies, involving 846 patients, found that the preservation of Scarpa's fascia during an abdominoplasty procedure was associated with decreased seroma occurrence, reduced drain output, faster drain removal, and fewer infections. However, it did not affect the incidence of hematoma, hospital stay duration, or wound dehiscence. The preservation of Scarpa's fascia during an abdominoplasty procedure should be considered as a routine practice, because it has been shown to result in reduced seroma incidence rates and faster drain removal.
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Parede Abdominal , Abdominoplastia , Humanos , Seroma/etiologia , Seroma/prevenção & controle , Seroma/epidemiologia , Abdominoplastia/efeitos adversos , Abdominoplastia/métodos , Parede Abdominal/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , FásciaRESUMO
The safety and effectiveness of facial cosmetic surgery procedures are dependent on detailed 3D understanding of the complex surgical anatomy of the face. Traditional, small sample size anatomical dissection studies have limitations in providing definitive clarification of the fascial layers of the face, and especially in their relationship with the facial nerve, and their reaction to surgical manipulation. The objective study of large tissue areas is required to effectively demonstrate the broader architecture. Conventional histology techniques were modified to handle extraordinarily large tissue samples to fulfill this requirement. Full-thickness soft tissue samples (skin to bone) of maximum length 18 cm, width 4 cm, and tissue thickness 1 cm, were harvested from 20 hemifaces of 15 fresh human cadavers (mean age at death = 81 years). After fixation, the samples were processed with an automated processor using paraffin wax for 156 h, sectioned at 30 µm, collected on gelatin-chromium-coated glass slides, stained with a Masson's Trichrome technique and photographed. Using this technique, excellent visualization was obtained of the fascial connective tissue and its relationship with the facial mimetic muscles, muscles of mastication and salivary glands in 73 large histological slides. The resulting slides improved the study of the platysma and superficial musculo-aponeurotic system (SMAS), the spaces and ligaments, the malar fat pad, and the facial nerve in relations to the deep fascia. Additionally, surgically induced changes in the soft-tissue organization were successfully visualized. This technique enables improved insight into the broad structural architecture and histomorphology of large-scale facial tissues.
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Ritidoplastia , Sistema Musculoaponeurótico Superficial , Humanos , Idoso de 80 Anos ou mais , Ritidoplastia/métodos , Fáscia/anatomia & histologia , Bochecha , Músculos FaciaisRESUMO
INTRODUCTION: A visible jowl is a reason patients consider lower facial rejuvenation surgery. The anatomical changes that lead to formation of the jowl remain unclear. The aim of this study was to elucidate the anatomy of the jowl, the mandibular ligament and the labiomandibular crease, and their relationship with the marginal mandibular branch of the facial nerve. MATERIALS AND METHODS: Forty-nine cadaver heads were studied (16 embalmed, 33 fresh, mean age 75 years). Following preliminary dissections and macro-sectioning, a series of standardized layered dissections were performed, complemented by histology, sheet plastination and micro-CT. RESULTS: The jowl forms in the subcutaneous layer where it overlies the posterior part of the mandibular ligament. The mandibular ligament proper exists only in the deep, sub-platysma plane, formed by the combined muscular attachment to the mandible of the specific lower lip depressor muscles and the platysma. The mandibular ligament does not have a definitive subcutaneous component. The labiomandibular crease inferior to the oral commissure marks the posterior extent of the fixed dermal attachment of depressor anguli oris. CONCLUSION: Jowls develop as a consequence of aging changes on the functional adaptions of the mouth in humans. To accommodate wide jaw opening with a narrowed commissure requires hypermobility of the tissues overlying the mandible immediately lateral to the level of the oral commissure. This hypermobility over the mandibular attachment of the lower lip depressor muscles occurs entirely in the subcutaneous layer to allow the mandible to move largely independent from the skin. The short, elastic subcutaneous connective tissue, which allows this exceptional mobility without laxity in youth, lengthens with aging, resulting in laxity. The development of subcutaneous and dermal redundancy constitutes the jowl in this location. LEVEL OF EVIDENCE IV: "This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ."
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Mandíbula , Sistema Musculoaponeurótico Superficial , Adolescente , Humanos , Idoso , Face/anatomia & histologia , Ligamentos/anatomia & histologia , EnvelhecimentoRESUMO
Background: The closure of extensive burn wounds with widely expanded autologous split-thickness skin grafts (STSG) is associated with undesirable scar formation and contraction, due to the lack of dermis. Various materials for dermal replacement have been developed, either of xenogeneic, allogeneic or synthetic origin and are placed in the wound underneath a thin STSG in order to improve scar quality. In this study, a porcine wound model was used to compare several commercially available acellular dermal substitutes with an acellular dermal substitute prepared from glycerol preserved human skin: Glyadermâ. Methods: Antigenic components of the allografts were removed by incubation in the 0.06 M NaOH solution. In the first experiments, the dermal substitutes were applied to full thickness wounds and covered simultaneously with STSG. Controls were covered with STSG only. The wound healing response was analyzed for 8 weeks, both macroscopically and histologically. The Mann-Whitney U test was used for statistical analysis. In the second series of experiments, Glyadermâ was applied in a two-stage procedure in comparison to Integra. The STSG was placed on the dermal substitutes one week later. Results: In the first series, the inflammatory response and myofibroblast influx in Glyadermâ were limited, indicating possible beneficial outcomes on final wound healing results. The survival of the STSG on the acellular dermis was lower compared to the control wounds. Second series: the take of the STSG was the same as in the controls, but additionally wound contraction was reduced. The application of Glyadermâ was non-inferior to Integra. Conclusion: Glyadermâ can be successfully used for the reduction of wound contraction when applied in a two-stage procedure.
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BACKGROUND: The female breast comes in many different shapes and sizes. The literature remains inconclusive on the ideal breast size. This study aims to investigate and compare breast size preferences among three cohorts (patients, plastic surgeons, and laypeople) to provide a better understanding of Western European ideals. METHODS: Patients, plastic surgeons, and laypeople were interviewed using a survey containing three-dimensional simulations of nine females, each depicted using five simulations with increasing breast size (1 = natural breast without breast implants, 2 = moderate, 3 = moderate plus, 4 = high, and 5 = ultra-high). Linear regression models were performed to define statistically significant associations between preferred breast size and predictor variables. RESULTS: In total, 28 patients, 45 plastic surgeons, and 100 laypeople (50 males and 50 females) participated in this study. On average, patients (3.5 ± 0.7) preferred larger breast sizes compared to surgeons (3.0 ± 0.7) and laypeople (3.1 ± 0.8). The difference between patients and surgeons was statistically significant. Overall, males preferred larger breast sizes than women. Patients of older age and with a higher BMI preferred larger breast sizes, while higher educational level was significantly associated with smaller breast size preference. Female plastic surgeons would undergo breast augmentation, while male plastic surgeons and female lay participants seem more skeptical. CONCLUSIONS: Significant preferential differences exist between patients and surgeons. It is important for professionals to be aware of societal ideals and preferential differences to adequately consult patients and achieve more satisfactory results.
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Implante Mamário , Implantes de Mama , Mamoplastia , Cirurgiões , Cirurgia Plástica , Mama/cirurgia , Implante Mamário/métodos , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
BACKGROUND: In the last decades, autologous fat grafting has been used to treat adherent dermal scars. The observed regenerative and scar-reducing properties have been mainly ascribed to the tissue-derived stromal vascular fraction (tSVF) in adipose tissue. Adipose tissue's components augment local angiogenesis and mitosis in resident tissue cells. Moreover, it promotes collagen remodeling. We hypothesize that tSVF potentiates fat grafting-based treatment of adherent scars. Therefore, this study aims to investigate the effect of tSVF-enriched fat grafting on scar pliability over a 12-month period. METHODS AND DESIGN: A clinical multicenter non-randomized early phase trial will be conducted in two dedicated Dutch Burn Centers (Red Cross Hospital, Beverwijk, and Martini Hospital, Groningen). After informed consent, 46 patients (≥18 years) with adherent scars caused by burns, necrotic fasciitis, or degloving injury who have an indication for fat grafting will receive a sub-cicatricic tSVF-enriched fat graft. The primary outcome is the change in scar pliability measured by the Cutometer between pre- and 12 months post-grafting. Secondary outcomes are scar pliability (after 3 months), scar erythema, and melanin measured by the DSM II Colormeter; scar quality assessed by the patient and observer scales of the Patient and Observer Scar Assessment Scale (POSAS) 2.0; and histological analysis of scar biopsies (voluntary) and tSVF quality and composition. This study has been approved by the Dutch Central Committee for Clinical Research (CCMO), NL72094.000.20. CONCLUSION: This study will test the clinical efficacy of tSVF-enriched fat grafting to treat dermal scars while the underlying working mechanism will be probed into too. TRIAL REGISTRATION: Dutch Trial Register NL 8461. Registered on 16 March 2020.
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Cicatriz , Fração Vascular Estromal , Tecido Adiposo , Cicatriz/diagnóstico , Cicatriz/etiologia , Cicatriz/patologia , Humanos , Transplante Autólogo/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: The aim of this study was to evaluate and compare the long-term (average, 6 years; range, 3 to 11 years) follow-up results of both the endoscopic and pretrichial open forehead lift. Both the amount of eyebrow elevation and patient satisfaction (FACE-Q questionnaires) were analyzed. METHODS: Preoperative and postoperative eyebrow positions of 65 patients were measured. Both eyebrow sides were measured at three different points. Thirty-two patients completed the FACE-Q questionnaires (10 domains, Dutch translation). RESULTS: Both the endoscopic and the pretrichial open forehead lift raised the eyebrow significantly at all measured points for each eye. This elevation effect was maintained significantly after long-term evaluation (average, 6 years; range 3 to 11 years), with no significant difference reported between techniques. After both procedures, patients were satisfied or strongly satisfied according to the FACE-Q questionnaires. CONCLUSION: Both the endoscopic forehead lift and the pretrichial open forehead lift raise the eyebrow significantly, and both have a long-term effect with either satisfied or strongly satisfied patients, as evaluated according to the FACE-Q questionnaire. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.