A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures.

Background: Skin preconditioning prior to and following procedures, has previously been demonstrated to hasten and optimize healing, and decrease the symptoms and signs associated with invasive surgery. These trials involved the use of multiple topical products. In an effort to control costs and to increase patient compliance, a single surgical product was developed, with actives aimed at decreasing swelling, bruising, induration, and internal fibrous banding. Objectives: This multi-center trial was designed to measure the efficacy of this single product in these mentioned parameters. Methods: A double-blind, randomized, split body, clinical study was undertaken in 29 patients involving 38 surgical procedures. Assessments included photography, biopsies, ultrasound imaging, and blinded investigator and participant assessments. Results: Differentiated results between test comparator sides became apparent at postop day 10-14 (as previously observed). Thus, blinded investigator and participant assessment scores demonstrated statistical significance exclusive to the test product side at postop day 10-14 for ecchymoses and then extending to skin discoloration, edema, induration and subcutaneous fibrous banding, at weeks 3, 4, 6, and 12. Ultrasound evaluation confirmed the earlier dissolution of fibrous banding on the test side in the subcutaneous tissue at the 3-6-week postop period. In addition, biopsies assessing the pre-conditioned period prior to surgery confirmed that the topical test product stimulated a remodeled extracellular matrix without comparative changes on the opposite side. Conclusions: A single peri-surgical product designed for the use with invasive surgery produced significant differences in ecchymosis, skin discoloration, edema, induration and ongoing resolution of fibrous banding over many weeks. This study validation provides an additional adjunct to surgical procedures.

Topical Skin Treatment and Its Influence on Surgical Healing: Review of Literature and Underlying Physiology.

TriHex Technology (Alastin Skincare, Carlsbad, CA) has been shown clinically to promote healing and outcomes post procedures and has been demonstrated clinically to improve lipid droplet dissolution and patient-reported outcomes post procedure. Histologically, the formulations have proven to regenerate collagen and elastin. The use of the technology to prepare the skin for surgical procedures combined with its use post procedure was assessed through clinical study outcomes, histological evidence, and gene expression analyses and demonstrated remodeling of the extracellular matrix (ECM), accelerating healing, and initiation of anti-inflammatory genes. While the improvement in clinical signs and outcomes has been validated, the changes taking place at a molecular level need to be explored. The interaction of cells (adipocytes, macrophages, fibroblasts) and the ECM proteins (collagen, elastin) secondary to the effects of the topical agent application are discussed. It appears that the manipulation of fat during body contouring surgery and the resultant adipocytolysis precipitates a molecular profile that can be positively directed toward hastened healing by using adjuvant topical applications as preconditioning prior to surgery and after the surgical procedure. Here, we review the literature and underlying physiology relating to these products and describe how interleukin 6 appears to be the primary facilitator of these effects.

An Analysis of Patient-Reported Recovery Outcomes of Topical Tripeptide/Hexapeptide Formulations Utilized in a Prospective Randomized Double-Blind Split Neck and Body Study.

BACKGROUND: Physicians strive to improve the postsurgical experience and optimize patient-reported recovery outcome measures (PROMs) following elective cosmetic surgical procedures. Our previous pilot feasibility study demonstrated that twice daily postoperative topical body treatment with tripeptide and hexapeptide (TransFORM Body Treatment with TriHex Technology [TFB, Alastin Skincare, Inc., Carlsbad, CA]) reduced PROMs of swelling, induration, soft tissue fibrosis, and pain as well as improved visible and palpable skin quality. OBJECTIVES: Evaluate whether adding a tripeptide/hexapeptide anhydrous gel (Regenerating Skin Nectar with TriHex Technology [RSN, Alastin Skincare, Inc., Carlsbad, CA]) pre- and post-procedure to the existing postsurgical regimen of TFB significantly improves 6 PROMs in patients undergoing neck and body contouring cosmetic surgical procedures. METHODS: Ten female patients underwent 15 neck and body contouring procedures and were blindly randomized to 1 of 2 topical treatment protocols (1 [TFB] and 2 [RSN/TFB]) pre- and post-procedure. Patient-reported scores of 5 skin parameters (skin discoloration, ecchymosis, edema, induration, and subcutaneous fibrous banding) and pain scores using the Visual Analog Scale were collected at 8 intervals for 12 weeks post-procedure. RESULTS: The treatment side that used both topicals showed significantly reduced scores of edema, induration, and subcutaneous fibrous banding compared with the side that only used 1 topical, on days 5-7 and 10-14 (P < 0.05). All patients observed slower soft tissue recovery on the side that was treated with TFB alone and opted to break the code and use both topical treatments. CONCLUSIONS: Patients had statistically significant improved patient-reported measures of skin edema, skin induration, and subcutaneous banding on the operated side that used both topicals.

The Leaky Pipeline of Women in Plastic Surgery: Embracing Diversity to Close the Gender Disparity Gap.

The Balance for Better campaign theme of the 2019 International Women's Day prompted a closer look at diversity within the plastic surgery specialty. Gender balance in the United States has improved through many organizational efforts and enactment of laws. Unfortunately, despite these endeavors, statistics show that men still enjoy greater financial and career success. Within the field of medicine, a similar trend has been observed. Although women constitute 50% of medical school graduates, the majority still enter fields outside of surgical subspecialties. In comparison to other surgical subspecialties, women are most represented in plastic surgery. Unfortunately, significant gender discrepancies remain in postgraduate practice including academic practice rank, societal board membership, invited speaker opportunities, and compensation, to name a few. The "leaky pipeline" of women describes the precipitous decline in the numbers of women at each step up the professional ladder. We explore the multifaceted nature of this phenomenon and highlight factors that contribute to limiting female growth within the plastic surgery profession. We also emphasize the continued growth of female plastic surgeon presence in all sectors despite these existing obstacles. We submit that continued leadership, mentorship, and sponsorship provided by both male and female physicians in the field will facilitate future leadership, advance gender parity, and cultivate a sense of belonging within the plastic surgery community, allowing brilliant minds to flourish and the profession to thrive.

Using the BODY-Q to Evaluate Appearance and Quality of Life Following Treatment of Skin Laxity of the Outer Thigh with Microfocused Ultrasound and Calcium Hydroxylapatite.

BACKGROUND: Two procedures that have demonstrated collagen-stimulating properties and improvements in skin laxity in a variety of aesthetic indications are microfocused ultrasound with visualization (MFU-V) and injection with calcium hydroxylapatite (CaHA). OBJECTIVES: By treating skin laxity with a combination of these therapies, it was hypothesized that our patients would experience improved appearance and quality of life as measured by the BODY-Q. METHODS: A total of 60 consecutive female patients aged 30 to 60 years with body mass index less than 28 kg/m2 who expressed interest in treatment for skin laxity affecting the outer thighs completed selected scales (Body Image, Appraisal of Excess Skin, Satisfaction with Hips and Outer Thighs, and Appearance-Related Psychosocial Distress) from the BODY-Q within 1 week of treatment. At the time of treatment, MFU-V was directed to the outer thighs (150 lines at focal depths of 3.0 and 4.5 mm per outer thigh). Immediately following MFU-V, patients received treatment with CaHA injected into the subdermis (1.5 mL diluted 1:1 with 1.5 mL of 2% lidocaine solution per outer thigh). At 90 days posttreatment, these patients repeated the BODY-Q. RESULTS: At 90 days posttreatment, with 100% follow-up among the 60 consecutive female patients treated, scores from the BODY-Q scales showed statistically significant improvement (P < 0.01). CONCLUSIONS: Following treatment of skin laxity on the outer thighs with a combination of MFU-V and CaHA, our patients reported a statistically significant improvement in appearance and quality of life at 90 days posttreatment. This protocol may be applicable to other areas of the body.

Facial Soft-Tissue Fillers: Assessing the State of the Science conference---Proceedings report.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report summarizes the deliberations and key points made by the panel and presenters to the panel, and includes a summary of the panel's near-term and longer term recommendations for next steps to help guide future efforts to address the safety, efficacy, and effectiveness of facial soft-tissue fillers. This report represents the panel's assessment of the medical knowledge available on facial soft-tissue fillers at the time of the conference.

Facial Soft-Tissue Fillers conference: Assessing the State of the Science.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Facial soft-tissue fillers conference: assessing the state of the science.

SUMMARY: : The American Society of Plastic Surgeons and the American Academy of Dermatology, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Society of Plastic Surgeons and the American Academy of Dermatology established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Nonsurgical rejuvenation of the aging face with injectable poly-L-lactic acid for restoration of soft tissue volume.

BACKGROUND: Characteristics of the aging face include soft tissue atrophy, loss of skin elasticity resulting in excess facial skin, and gravitational descent or ptosis of facial soft tissues. Poly-L-lactic acid (PLLA) is a synthetic biodegradable polymer that provides soft tissue augmentation through stimulation of an inflammatory tissue response with subsequent collagen deposition. OBJECTIVE: The authors discuss the special considerations inherent in facial aging, describe the mechanism of action and indications for a new PLLA filler under consideration for Food and Drug Administration (FDA) approval (Sculptra Aesthetic, sanofi-aventis US, Bridgewater, New Jersey), and detail the results of a two-year off-label pilot study with the product. METHODS: The senior author (LAC) treated 106 patients with PLLA in an off-label indication, as part of a pilot study while Sculptra Aesthetic was being evaluated for FDA approval for cosmetic indications. All patients were followed up for two years to help develop a protocol for injection technique. RESULTS: The age range of patients in this series was 40 to 78 years. Three patients were male and 103 were female. Patients received an average injection of 1.6 vials per session, over an average of 2.3 sessions, to achieve volume restoration in the tear trough, midface, malar region, nasolabial folds, prejowl area, mandibular border, and mandibular angle. The authors we achieved 100% follow-up with 99.1% patient satisfaction. The rate of nodule formation was 4.7% at a minimum follow-up of two years. CONCLUSIONS: Because of its unique mechanism of action, PLLA for nonsurgical facial rejuvenation requires meticulous injection technique with special considerations for optimizing outcomes and minimizing adverse events.

Superior pedicle autoaugmentation mastopexy: a review of 34 consecutive patients.

BACKGROUND: The ptotic breast deformity results from two synergistic forces: involution of breast parenchyma leading to a loss of volume, along with a converse laxity of the skin envelope, which becomes inelastic and accommodating. As the breast tissue descends inferiorly on the chest wall with gravity, there is an apparent volume loss in the upper pole and the central breast, and the lower pole becomes fuller and often wider. OBJECTIVES: The authors propose a technique whereby the superior pedicle vertical mammaplasty technique originally described by Lassus is modified to include transposition of glandular tissue to restore central mound projection while simultaneously narrowing the lower breast base and raising the inframammary crease. METHOD: From 2003 to 2007, 34 patients underwent a superior pedicle autoaugmentation mammaplasty. Ages ranged from 22 to 47 years. The mean follow-up period was 24 months. Patients were selected preoperatively based on the presence of wide, low-lying breasts lacking central projection. In all cases, the patients expressed a desire to have a more youthful breast without the presence of an implant. The breast tissue usually retained in an inferior breast reduction was elevated on a superior dermal pedicle blood supply and transposed into a prepectoral pocket under the central breast. The medial and lateral pillars were then sutured together to narrow the breast base. RESULTS: All patients tolerated their procedure well. Two patients developed seromas that were percutaneously drained in the office. All 34 patients stated that they were very satisfied with the shape and size of their breasts postoperatively. No patient desired subsequent breast augmentation. CONCLUSIONS: Modifying the vertical-scar mastopexy originally described by Lassus and later refined by Lejour, Hall-Findlay, and de la Plaza et al, the authors have created a dermoglandular extension of the superior pedicle that can be transposed behind the nipple-areolar complex. This restores central mound projection while also narrowing the lower breast base and raising the inframammary crease. In carefully selected patients with low-lying, wide breasts who do not desire breast augmentation without a prosthetic, this technique can be employed to reliably recreate a more youthful breast shape.

Multisite analysis of 177 consecutive primary breast augmentations: predictors for reoperation.

BACKGROUND: Plastic surgeons and manufacturers of breast implants have been examining the complication and reoperation rates of primary breast augmentations for more than 18 years. The seemingly high rates reported by the manufacturers to the United States Food and Drug Administration (FDA) were the impetus for this multicenter study. OBJECTIVE: This paper reports on data pooled from three plastic surgery practices that were geographically distributed across the United States and examines the reoperation rate, time to reoperation, the reason for reoperation, and specific complications in 177 consecutive primary breast augmentation patients. These data are statistically compared to the manufacturers' 2005 and 2008 FDA data. In addition, the significance of selected variables from our data are examined as predictors for reoperation. METHODS: Data were retrospectively collected from 177 consecutive primary breast augmentations performed between 2001 and 2004 from three surgical practices. Direct physician-to-patient follow-up periods ranged from 12 to 58 months, with 100% of patients having at least one year of follow-up. Each practice extracted chart data on variables and complications, including reoperations. These data were independently collated and sent to an independent biostatistician for analysis. RESULTS: Our three year Kaplan-Meier (KM) reoperation rate (8%) and capsular contracture rate (2%) were both lower than the manufacturers' KM 3-year rates for reoperation (13%-21%) and capsular contracture (8.2%-9%). Logistic regression identified only simultaneous mastopexy and preexisting ptosis as predictors of reoperation.

Two-year results of a prospective, multi-site investigation of patient satisfaction and psychosocial status following cosmetic surgery.

BACKGROUND: The number of cosmetic surgical and nonsurgical procedures performed in the United States has increased by 500% over the past 10 years. Most studies of psychosocial functioning following aesthetic procedures have reported high levels of patient satisfaction and improved functioning; however, nearly all these studies focused only on changes during the first posttreatment year. OBJECTIVE: This paper reports on the 2-year results of a prospective, multi-site investigation of postoperative satisfaction and changes in psychosocial status following cosmetic surgery. METHODS: One hundred patients from 8 surgical practices completed psychometric measures of body image, depressive symptoms, and self-esteem before surgery. Patients completed the same measures again at 3, 6, 12, and 24 months postoperatively. In addition, they reported their postoperative satisfaction as well as self-rated attractiveness at the 4 postoperative assessment points. RESULTS: Patients reported improvements in their overall appearance and body image, the appearance of and their degree of dissatisfaction with the feature altered by surgery, and the frequency of negative body image emotions in specific social situations through 24 months after surgery. These improvements were first evident at 3 months postoperatively and were maintained, without deterioration, through 2 years following surgery. CONCLUSIONS: Patients reported high rates of satisfaction and improvements in body image within the first 3 months of cosmetic surgery. These improvements were well maintained through the first 2 postoperative years.

The effect of zafirlukast (Accolate) on early capsular contracture in the primary augmentation patient: a pilot study.

BACKGROUND: The development of capsular contracture following breast augmentation presents a challenge to the plastic surgeon. Treatment of capsular contracture with the leukotriene antagonist zafirlukast (Accolate, AstraZeneca, Wayne, PA) has received much attention in the media; however, there is limited proof of its effectiveness. OBJECTIVE: The purpose of this study was to prospectively examine a single surgeon's experience using zafirlukast in the treatment of capsular contracture in primary, submuscular breast augmentation with saline-filled, smooth-walled implants. METHODS: Thirty-seven patients (74 breasts) who underwent primary submuscular breast augmentation with saline-filled, smooth-walled implants were evaluated at 1, 2, 4, 6, 12, 24, and 48 weeks postoperatively by 3 independent observers and rated for capsular contracture using a modification of the Baker classification. Patients who demonstrated any capsular contracture (higher than modified Baker 1.0) were offered off-label use of zafirlukast 20 mg PO BID for 3 or 6 months after full informed consent was reviewed and accepted. In addition, patients were offered liver function chemistries at the start of treatment and at 1, 3, and 6 months following zafirlukast treatment. The patients were assessed for implant mobility and capsular contracture at the initiation of leukotriene therapy and then again at 3- and 6-month time points. RESULTS: Forty-one breasts in this series (55.0%) were found to have early, mild capsular contracture. Specifically, 25 breasts were graded 1.5 (33.8% of total), 14 breasts graded 2.0 (18.9%), 1 breast graded 2.5 (1.4%), and 1 breast graded 3.0 (1.4%). Mean follow-up was 6.3 months. A positive response (complete or partial) was seen in a statistically significant proportion of treated breasts (75.7%, P < 0.05). This response was maintained on a long-term basis, with a mean follow-up of 16.5 months. CONCLUSIONS: Zafirlukast appears effective in treating early capsular contracture after primary submuscular breast augmentation using saline-filled, smooth-walled implants. Further prospective studies with control groups and long-term follow-up will be needed to address many unanswered questions, including whether leukotriene inhibitors have long-term effects on capsular contracture following breast augmentation.

A prospective, multi-site investigation of patient satisfaction and psychosocial status following cosmetic surgery.

BACKGROUND: Although several studies have investigated patient satisfaction and changes in body image following aesthetic plastic surgery, few have investigated more specific dimensions of body image, including dysphoric emotions that occur in specific social situations or body image quality of life. In addition, few studies have investigated changes in body image that may occur in concert with changes in more general areas of psychosocial functioning, such as depressive symptoms and self-esteem. OBJECTIVE: This prospective, multi-site study investigated postoperative satisfaction and changes in psychosocial status following cosmetic surgery. METHODS: One hundred patients recruited from 8 geographically diverse surgical practices completed psychometric measures of body image, depressive symptoms, and self-esteem prior to surgery. Seventy-two patients completed the 3-month postoperative assessment, 67 completed the 6-month assessment, and 63 completed the 12-month assessment. All statistical tests on changes after surgery were conducted using the sample of 72 patients who completed the 3-month assessment. A Last Observation Carried Forward analysis was used to account for patients who did not complete the subsequent follow-up assessments. In addition, they reported their postoperative satisfaction as well as self-rated attractiveness at the 3 postoperative assessment points. RESULTS: Eighty-seven percent of patients reported satisfaction with their postoperative outcomes. Patients also reported significant improvements in their overall appearance, as well as the appearance of the feature altered by surgery, at each of the postoperative assessment points. Patients experienced significant improvements in their overall body image, their degree of dissatisfaction with the feature altered by surgery, and the frequency of negative body image emotions in specific social situations. All of these improvements were maintained 12 months after surgery. CONCLUSIONS: These results add to a growing body of literature documenting improvements in body image following cosmetic surgery.