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.

The Safe Resumption of Elective Plastic Surgery in Accredited Ambulatory Surgery Facilities During the COVID-19 Pandemic.

BACKGROUND: On March 11, 2020, the World Health Organization declared the novel Coronavirus-19 (COVID-19) a worldwide pandemic, resulting in an unprecedented shift in the Canadian healthcare system, where protection of an already overloaded system became a priority; all elective surgeries and non-essential activities were ceased. With the impact being less than predicted, on May 26, 2020, elective surgeries and non-essential activities were permitted to resume. OBJECTIVES: The authors sought to examine outcomes following elective aesthetic surgery and the impact on the Canadian healthcare system with the resumption of these services during the COVID-19 worldwide pandemic. METHODS: Data were collected in a prospective manner on consecutive patients who underwent elective plastic surgery procedures in 6 accredited ambulatory surgery facilities. Data included patient demographics, procedural characteristics, COVID-19 polymerase chain reaction (PCR) test status, airway management, and postoperative outcomes. RESULTS: A total of 368 patients underwent elective surgical procedures requiring a general anesthetic. All 368 patients who underwent surgery were negative on pre-visit screening. A COVID-19 PCR test was completed by 352 patients (95.7%) and all were negative. In the postoperative period, 7 patients (1.9%) had complications, 3 patients (0.8%) required a hospital visit, and 1 patient (0.3%) required hospital admission. No patients or healthcare providers developed COVID-19 symptoms or had a positive test for COVID-19 within 30 days of surgery. CONCLUSIONS: With appropriate screening and safety precautions, elective aesthetic plastic surgery can be performed in a manner that is safe for patients and healthcare providers and with a very low risk for accelerating virus transmission within the community.

Reoperation Rate After Primary Augmentation With Smooth, Textured, High Fill, Cohesive, Round Breast Implants (RANBI-I Study).

BACKGROUND: Reoperation after primary breast augmentation remains an important clinical issue. OBJECTIVE: The authors sought to evaluate incidence and causes of reoperation in patients who underwent primary augmentation. METHODS: This retrospective, noninterventional study conducted at 16 Canadian sites reviewed medical records and patient-completed questionnaires of women who underwent primary breast augmentation with smooth or textured Natrelle Inspira implants containing TruForm 1 or TruForm 2 gel. Patients were aged ≥22 years, received implants via inframammary fold incision, and returned for follow-up at 2 to 4 years. RESULTS: A total of 319 women received Inspira implants (smooth TruForm 2, n = 205; textured TruForm 2, n = 99; smooth or textured TruForm 1, n = 15). At follow-up, 30 women (9.4%) had undergone reoperation, including 19 (9.3%) in the smooth TruForm 2 subgroup and 9 (9.1%) in the textured TruForm 2 subgroup. The mean time to reoperation was 1.2 years; the risk rate for reoperation was 9.9% at 3 years. The most common reasons for reoperation were implant malposition (36.7%), capsular contracture (33.3%), and the patient's request for a change in implant size or style (20.0%). Most women were very or somewhat satisfied with the initial surgery (89.3% overall; 90.7% smooth TruForm 2; 86.9% textured TruForm 2). Thirty-four women (10.7%) reported adverse events, including 20 (9.8%) in the smooth TruForm 2 subgroup and 14 (14.1%) in the textured TruForm 2 subgroup. CONCLUSIONS: This analysis suggests that Natrelle Inspira TruForm 2 implants are safe when used in primary breast augmentation, resulting in low reoperation rates that are consistent with those for other breast implants.

A Multicenter, Retrospective Evaluation of Tissue Stabilized-Guided Subcision in the Management of Cellulite.

BACKGROUND: The first FDA-cleared, long-lasting, minimally invasive device for improving the appearance of cellulite was recently launched in Canada as a novel, tissue stabilized-guided subcision (TS-GS) system (Cellfina, Merz North America, Inc., Raleigh, NC). Clinicians from 2 of the first Canadian sites offering this procedure were interested in evaluating treatment efficacy and patient satisfaction after its first year on the market. OBJECTIVES: The authors sought to evaluate the efficacy of TS-GS and the level of patient satisfaction associated with the procedure. METHODS: Medical charts of female patients treated with the TS-GS system in 2017 were retrospectively analyzed at 2 Canadian centers. Measurements at baseline and 3 months posttreatment were assessed for patient satisfaction and physician-rated efficacy. Patient satisfaction was assessed using a 5-point Likert-type scale, and efficacy was evaluated through physician review of 2-deminsional and 3-dimensional photography, the Nürnberger-Müller Scale for cellulite, and the Global Assessment of Improvement Scale. RESULTS: We reviewed 25 patient charts. At month 3, 95.6% of patients were satisfied with treatment results and physician evaluations revealed that on average, patients displayed a 1-point improvement in their cellulite grades. Moreover, Global Assessment of Improvement Scale scores indicated that all patients had visible improvement in the global appearance of cellulite. No serious adverse events were observed within 3 months postprocedure. CONCLUSIONS: The physician ratings, patient satisfaction, and photographic evidence support the efficacy of the TS-GS system to manage grades 1 to 3 cellulite in women's thighs and buttocks. These findings indicate the safety of the TS-GS system.Level of Evidence: 4.

A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging.

Objective: To examine the effectiveness of intradermal botulinum toxin type A injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods. Design: A 16-week, single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal botulinum toxin type A injections at Week 0 and intramuscular botulinum toxin type A injections at Week 2. Participants: Ten women aged 35 to 65 years who exhibited static rhytids in the glabellar and periorbital area. Measurements: The primary endpoint was efficacy of split-face treatment of intradermal and intramuscular onabotulinumtoxinA and abobotulinumtoxinA as assessed by a blinded evaluator using baseline and post-treatment photographs. The secondary endpoints included safety as assessed by adverse events and patient satisfaction measured by questionnaires completed at baseline and post-treatment. Results: Intradermal injection of botulinum toxin type A led to a statistically significant improvement in skin texture (p=0.004) while also resulting in mild midface lift (p=0.024), but did not provide a significant reduction of pore size and sebum production. There was no statistically significant difference between onabotulinumtoxinA and abobotulinumtoxinA when injected intradermally or intramuscularly. Conclusion: Intradermal injection of botulinum toxin type A appears to be a safe and effective therapy that provides an improvement in facial skin texture and midface lift. Registry: clinicaltrials.gov (ID#: NCT02907268).