Influence of the Phenylephrine Test in Outcomes of External Levator Advancement for Involutional Ptosis.

PURPOSE: This study aims to evaluate the influence of preoperative phenylephrine testing on the surgical outcome of patients undergoing surgery for involutional ptosis by external levator advancement. METHODS: This was an observational, monocentric, retrospective study. Fifty-one eyelids from 32 patients, who had surgery between January 2018 and May 2023, were included for analysis. Preoperative clinical examination data were collected. Evaluation was performed at 1 month postoperatively. Surgical success was defined by a postoperative margin reflex distance between 3 and 5 mm inclusive. Symmetry success was defined by a difference in margin reflex distance between the 2 upper eyelids of no more than 1 mm. RESULTS: The surgical success rate was 86%. A positive preoperative phenylephrine test was significantly associated with a better surgical success rate (p = 0.01), including on symmetry (p = 0.01). The secondary outcomes, namely preoperative margin reflex distance, function of the upper eyelid levator muscle, and unilaterality of surgery, were not statistically associated with surgical outcome. CONCLUSIONS: The phenylephrine test is a predictive factor of surgical success in patients undergoing external levator advancement. Our study suggests that patients with a negative phenylephrine test should be overcorrected intraoperatively.

[The history of vaginoplasty: Technical and sociological advances]. / Histoire de la vaginoplastie : évolution technique et sociologique.

Technical advances in gender-affirming genital surgery have allowed the modern surgeon to create a vagina, vulva and clitoris from a male sex. This surgery, commonly known as vaginoplasty, should in fact be identified as aidopoiesis, since it is not a question of improving an already existing vagina but of creating a female sex. Numerous technical advances made since 1930 throughout the world now offer a safe and proven surgical strategy for female genital gender affirmation. Most of these techniques are derived from advances in intersex genital surgery. The first vaginoplasties described in the context of gender affirmation were performed in Berlin in the 1930s. After the Second World War, the greatest advances in vaginoplasty were made in Denmark. It was not until Geroges Burou in Casablanca and Harold Gillies, aided by Ralph Millard in England, in the mid-fifties that the modern technique of invagination of the penile skin took over from neo-vaginal grafting techniques. The creation of the clitoris from the glans penis and a more aesthetic vulva were the major advances from the 1970s. Other flap or intestinal transplant techniques were also developed, often to correct the failure of penile skin invagination. Some of the patients who benefited from these early technical advances, such as Lili Elbe and Christine Jorgensen later on, helped to make this surgery, which had long remained taboo, popular with the general public. Pioneers such as the gynaecologist Georges Burou in Casablanca have contributed, with the greatest discretion, to the well-being of gender-affirmed people by improving these techniques. Today, this hard-won heritage cannot be ignored by surgeons interested in vaginoplasty.

Clinical validation of an elastin-derived trifunctional peptide for skin regeneration.

Aging is associated with progressive skin fragility, characterized in part by extracellular matrix (ECM) fragmentation. This degradation produces matrikines which have an impact on ECM rremodeling. Our group previously designed and characterized a trifunctional peptide (TFP), constituted of i) an elastokine motif (VGVAPG)3, able to increase the expression of matrix constituent through the stimulation of the elastin-binding protein receptor, ii) a tripeptide inhibiting matrix metalloproteinase-1 activity (GIL), and iii) a linker domain acting as a competitive substrate for urokinase (RVRL). TFP was shown to activate the production of matrix constituents while inhibiting Matrix MetalloProtease MMP-1 in vitro on fibroblasts and ex vivo on skin explants. OBJECTIVE: In the present study, TFP properties were evaluated in a clinical assay. METHODS: Twenty-two volunteers applied a TFP-based cream on one hemi-face and a placebo-based cream on the other hemi-face, twice a day during 28 days, before undergoing a surgical lifting. Cutometry and skin relief measurements were performed at days 0 and 28, and skin explants from lifting surgery were used for histological analyses. RESULTS: Cutometry and skin relief measurements reveal TFP firming properties and wrinkle depth decrease in 28 days on TFP- as compared to placebo-treated hemi-faces. These results are confirmed by histological analyses showing an increase of the ratio between basal lamina and stratum corneum. Furthermore, immunostaining of collagen reveals a modification of the ratio between type I and III collagens. CONCLUSION: The combined analysis of phenotypic and histologic parameters demonstrates a reorganization of the ECM towards a regenerative profile upon TFP treatment.

In vivo efficacy proof of concept of a large-size bioprinted dermo-epidermal substitute for permanent wound coverage.

Introduction: An autologous split-thickness skin graft (STSG) is a standard treatment for coverage of full-thickness skin defects. However, this technique has two major drawbacks: the use of general anesthesia for skin harvesting and scar sequelae on the donor site. In order to reduce morbidity associated with STSG harvesting, researchers have developed autologous dermo-epidermal substitutes (DESs) using cell culture, tissue engineering, and, more recently, bioprinting approaches. This study assessed the manufacturing reliability and in vivo efficacy of a large-size good manufacturing practice (GMP)-compatible bio-printed human DES, named Poieskin®, for acute wound healing treatment. Methods: Two batches (40 cm2 each) of Poieskin® were produced, and their reliability and homogeneity were assessed using histological scoring. Immunosuppressed mice received either samples of Poieskin® (n = 8) or human STSG (n = 8) immediately after longitudinal acute full-thickness excision of size 1 × 1.5 cm, applied on the skeletal muscle plane. The engraftment rate was assessed through standardized photographs on day 16 of the follow-up. Moreover, wound contraction, superficial vascularization, and local inflammation were evaluated via standardized photographs, laser Doppler imaging, and PET imaging, respectively. Histological analysis was finally performed after euthanasia. Results: Histological scoring reached 75% ± 8% and 73% ± 12%, respectively, displaying a robust and homogeneous construct. Engraftment was comparable for both groups: 91.8% (SD = 0.1152) for the Poieskin® group versus 100% (SD = 0) for the human STSG group. We did not record differences in either graft perfusion, PET imaging, or histological scoring on day 16. Conclusion: Poieskin® presents consistent bioengineering manufacturing characteristics to treat full-thickness cutaneous defects as an alternative to STSG in clinical applications. Manufacturing of Poieskin® is reliable and homogeneous, leading to a clinically satisfying rate of graft take compared to the reference human STSG in a mouse model. These results encourage the use of Poieskin® in phase I clinical trials as its manufacturing procedure is compatible with pharmaceutical guidelines.

Immediate Proximal Row Carpectomy for Severe Perilunate Dislocation Injuries: A Minimum 5-Year Follow-Up.

Background: In patients with perilunate injuries (PLI) with multiple ligamentous and bony injuries involving the proximal carpal row, open reduction and internal fixation (ORIF) can be difficult and lead to poor functional outcomes. Proximal row carpectomy (PRC) is an alternative procedure that has been used for severely comminuted fractures. The aim of our study is to evaluate the long-term functional outcome (minimum 5 years) of patients that underwent an emergency PRC for PLI. Methods: We conducted a retrospective study of patients who underwent PRC at our centre between 2001 and 2016. Only patients with follow-up data of more than 5 years were included in the study. We evaluated range of motion, grip strength, Mayo Modified Wrist Score (MMWS) and Quick Disabilities of Arm, Shoulder and Hand (Quick-DASH). Radiographic analyses were performed to assess the presence of radiocarpal osteoarthritis and the space between the radius and capitate. Results: Thirteen patients were included, with an average follow-up of 78.07 months (6.5 years). The MMWS was 65 points (four excellent and good, four fair and five poor results) and the Quick-DASH score was 30 points. X-ray analysis reported only 15.3% of patients with radiocarpal arthrosis and an average radio-capitate joint space of 1.92 mm. Conclusions: The outcomes of PRC in the management of PLI are comparable to the results reported in literature for conventional ORIF. PRC is a simpler procedure that minimises the need for re-intervention. Level of Evidence: Level IV (Therapeutic).

Increasing the Reach of the Submental Artery Island Flap Using the Y-V Pedicle Lengthening Technique: Video and Technical Considerations.

SUMMARY: This article and instructional video detail a step-by-step approach to performing the Y-V venous pedicle lengthening technique, which can be used to increase the reach of the submental artery island flap by up to 5 cm, permitting reconstruction of soft-tissue defects of the middle and upper thirds of the face. This technique can also be used to maximize advancement of many common flaps around the body, including the medial plantar and lateral arm flaps.

Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions.

BACKGROUND: Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria. METHODS: This retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction, and microbiological quality. RESULTS: Stromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) and recovery yield (2.54 × 105 ± 1.22 × 105 viable nucleated cells (VNCs) per mL of adipose tissue) than stromal vascular fraction from AP-HM (84.20% ± 5.96% and 2.25 × 105 ± 1.11 × 105 VNCs per mL). AP-HM batches were significantly less contaminated (95.71% of sterile batches versus 74.15% for SSCF batches). The cell subset distribution was significantly different (higher proportion of endothelial cells and lower proportion of leukocytes and pericytes in SSCF cohort). CONCLUSIONS: Both centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 105 VNCs per mL of adipose tissue, a proportion of adipose-derived stromal cells at least equal to 20%, and a proportion of leukocytes under 50%. In addition, a multiparameter gating strategy for stromal vascular fraction analysis is proposed.

Anatomical study of the clitoris and its implications on female genital mutilation and surgical repair.

BACKGROUND: Worldwide, 200 million girls and women have been subjected to female genital mutilation. To restore the clitoral function and vulvar anatomy, clitoral repair has been performed since the 2000s. Nevertheless, there is a lack of precise and comprehensive data on the clitoral anatomy during surgical repair. This study aimed to precisely describe the terminal anatomies of the dorsal nerve and artery of the clitoris, and the clitoral neurovascular flap advancement for reconstruction in patients with female genital mutilation. METHODS: This study was performed on seven fresh female cadavers. The site of origin, diameter, length, and trajectory of each nerve and artery were recorded. The clitoral neurovascular flap advancement was measured after a midline transection of the suspensory ligament was performed and after extensive liberation of the dorsal bundles at their emergence from the pubic rami. RESULTS: At the distal point of the clitoral body, the width of the dorsal nerve and artery was 1.9 ± 0.3 mm and 0.9 ± 0.2 mm, respectively. The total length of the dorsal bundles was 6.6 cm (± 0.4). The midpart of the suspensory ligament was sectioned, which allowed a mean anteroposterior mobility of 2.7 cm (± 0.2). Extensive dissection of the neurovascular bundles up to their point of emergence from the suspensory ligament allowed a mean mobility of 3.4 ± 0.2 cm. CONCLUSION: We described the anatomical characteristics of the dorsal nerve and artery of the clitoris and the mobility of the clitoral neurovascular flap for reconstruction post clitoridectomy. This was done to restore the anatomic position of the glans clitoris while preserving and potentially restoring clitoral function in patients with female genital mutilation.

Is minor surgery safe during the COVID-19 pandemic? A multi-disciplinary study.

BACKGROUND: To assess the risk of postoperative SARS-CoV-2 infection during the COVID-19 pandemic. METHODS: The CONCEPTION study was a cohort, multidisciplinary study conducted at Conception University Hospital, in France, from March 17th to May 11th, 2020. Our study included all adult patients who underwent minor surgery in one of the seven surgical departments of our hospital: urology, digestive, plastic, gynecological, otolaryngology, gynecology or maxillofacial surgery. Preoperative self-isolation, clinical assessment using a standardized questionnaire, physical examination, nasopharyngeal RT-PCR and chest CT scan performed the day before surgery were part of our active prevention strategy. The main outcome was the occurrence of a SARS-CoV-2 infection within 21 days following surgery. The COVID-19 status of patients after discharge was updated during the postoperative consultation and to ensure the accuracy of data, all patients were contacted again by telephone. RESULTS: A total of 551 patients from six different specialized surgical Departments in our tertiary care center were enrolled in our study. More than 99% (546/551) of included patients underwent a complete preoperative Covid-19 screening including RT-PCR testing and chest CT scan upon admission to the Hospital. All RT-PCR tests were negative and in 12 cases (2.2%), preoperative chest CT scans detected pulmonary lesions consistent with the diagnosis criteria for COVID-19. No scheduled surgery was postponed. One patient (0.2%) developed a SARS-CoV-2 infection 20 days after a renal transplantation. No readmission or COVID-19 -related death within 30 days from surgery was recorded. CONCLUSIONS: Minor surgery remained safe in the COVID-19 Era, as long as all appropriate protective measures were implemented. These data could be useful to public Health Authorities in order to improve surgical patient flow during a pandemic.

[Total reconstruction of the lower lip: Lip suspension technique by double nasolabial rigging and review of the literature]. / Reconstruction totale de la lèvre inférieure : technique de suspension labiale par double haubanage nasogénien et revue de la littérature.

BACKGROUND: Total lower lip defect is rare and its reconstruction difficult. The challenges are both aesthetic and functional. Suspension of the lower lip is essential for restoring oral competence. We report an original and simple technique of suspension by double nasolabial rigging. METHOD: Two upper base orbitonasolabial flaps, extended over several centimeters below the lip commissures are raised. The epidermis is completely removed. Then, the flaps are tunneled under the skin and fixed to the reconstructed lower lip in order to provide it with effective suspension to the maxillary. RESULTS: In our experience, we used the nasolabial rigging associated with a total reconstruction of the lower lip for three patients. Lip continence is effective in the long term. The review of literature shows that the use of conventional locoregional flaps restores a good labial competence but is limited to subtotal lower lip defect. Distant pedicled flaps or free flaps made without suspension of the lower lip don't restore the labial competence. Several procedures to suspend the lower lip with strips of fascia lata or tendon of palmaris longus, associated or not with a free flap, seem to provide satisfactory oral competence. All these techniques are poorly standardized and technically difficult. CONCLUSION: The technique of the double nasolabial rigging that we describe seems to be an effective and interesting alternative by its simplicity, its reproducibility and its adaptability. It allows to obtain a perfectly fixed posterior plane, able to receive any reconstruction of the lower lip.

The modified serratus anterior fascia flap improves satisfaction and long-term results in immediate implant-based breast reconstruction: A retrospective study.

After immediate implant-based breast reconstruction (IIBR) following skin-sparing mastectomy, postoperative complications such as implant exposure or badly defined mammary folds can occur. Acellular dermal matrix can provide good esthetic outcomes but remain expensive. This study evaluates a new technique of one-stage IIBR by using a modified serratus anterior fascia flap (MSFF group), providing lower implant coverage, as compared to the classical submuscular technique. In this retrospective study, we included all patients who underwent IIBR using either the MSFF technique or the classic technique between November 2012 and February 2015. We collected data regarding demographics, perioperative factors, postoperative complications, patient satisfaction (Breast-Q score), and esthetic outcomes. One hundred twenty-three patients who underwent IIBR, of which 61 breasts (59 patients) using the MSFF and 67 breasts (64 patients) the classical technique, were included. The size of the implants used were significantly higher in the MSFF group (p = 0.036). There were no statistically significant differences between the two groups with regard to the immediate complications rate. After a mean follow-up of 43.9 months, we observed more capsular contractures in the classic group (p < 0.001). In the classic group, patients required more revision surgeries (p = 0.008), more implant changes (p < 0.001), and higher volume of additional lipofilling (p < 0.001). According to the Breast Q scores, patients' satisfaction was better in the MSFF group regarding their breasts (p = 0.001) and the outcomes (p = 0.009). The MSFF is a simple, safe, effective, and inexpensive autologous technique for IIBR, which improves implant coverage with a vascularized flap and provides satisfying outcomes as compared to classic IIBR, with less complications.

Development and Validation of a Fully GMP-Compliant Process for Manufacturing Stromal Vascular Fraction: A Cost-Effective Alternative to Automated Methods.

The therapeutic use of adipose-derived stromal vascular fraction (SVF) is expanding in multiple pathologies. Various processes have been proposed for manufacturing SVF but they must be revisited based on advanced therapy medicinal product (ATMP) regulations. We report here the development and validation of a fully good manufacturing practices (GMP)-compliant protocol for the isolation of SVF. Adipose tissue was collected from healthy volunteers undergoing lipoaspiration. The optimal conditions of collagenase digestion and washing were determined based on measurements of SVF cell viability, yield recovery, and cell subset distribution. Comparability of the SVF obtained using the newly developed manufacturing process (n = 6) and the Celution-based automated method (n = 33), used as a reference, was established using inter-donor analyses. Characteristics of SVF (n = 5) generated using both manufacturing protocols were analyzed for an intra-donor comparison. In addition, these comparisons also included the determination of colony-forming unit fibroblast frequency, in vitro angiogenic activity, and in vivo regenerative effects in a mouse ischemic cutaneous wound model. We successfully developed a process for the generation of SVF presenting higher cell viability and yield recovery compared to the Celution device-based protocol. Characteristics of the SVF including phenotype, capacity for angiogenesis, and wound-healing promotion attested to the comparability of the two manufacturing processes. We validated an optimized non-automated process that should allow for a GMP-compliant, more affordable, and reduced-cost strategy to exploit the potential of SVF-based regenerative therapies.

Supportive use of platelet-rich plasma and stromal vascular fraction for cell-assisted fat transfer of skin radiation-induced lesions in nude mice.

BACKGROUND: External radiotherapy has become indispensable in oncological therapies. Unfortunately, radiation is responsible for serious side effects, such as radiodermatitis. The skin is weakened and ulcerated. Our study aimed to evaluate the subcutaneous transfer of microfat (MF) alone and two mixes: MF+Platelet-rich plasma (PRP) and MF+stromal vascular fraction (SVF) to treat radiation-induced skin lesions. METHOD: We defined randomly five experimental groups of nine mice: 1 healthy control group and 4 irradiated (60 Grey) and treated groups. The skin lesions were treated 3 months after irradiation by MF, MF+PRP (50%-50%), MF+SVF (90%-10%) or Ringer-lactate subcutaneous injections. Wound healing was evaluated at 1, 2 and 3 months post-injection and histological wound analysis at 3 months, after euthanasia. RESULTS: All the irradiated mice presented with wounds. After sham-injection, the wound area increased by 91.1±71.1% versus a decrease of 15.9±23.1% after MF alone (NS), 27.3±23.8% after MF+SVF (NS) and 76.4±7.7% after MF+PRP (P=0.032). A significative reduction of skin thickness in wound periphery was measured for the three treated groups compared to sham-injection (P<0.05) but not in the healed wounds (NS). The most important subcutaneous neo-vessel density was shown after MF+SVF injection. CONCLUSION: The MF+PRP mix was the most efficient product to increase healing. The MF+SVF mix showed the highest rate of neo-angiogenesis but was disappointing in terms of healing. LEVEL OF EVIDENCE: Not gradable.

Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial.

Importance: Patients with scarred vocal folds, whether congenitally or after phonosurgery, often exhibit dysphonia that negatively affects daily life and is difficult to treat. The autologous adipose tissue-derived stromal vascular fraction (ADSVF) is a readily accessible source of cells with angiogenic, anti-inflammatory, immunomodulatory, and regenerative properties. Objective: To evaluate the feasibility and tolerability of local injections of autologous ADSVF in patients with scarred vocal folds. Design, Setting, and Participants: CELLCORDES (Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction) is a prospective, open-label, single-arm, single-center, nonrandomized controlled trial with a 12-month follow-up and patient enrollment from April 1, 2016, to June 30, 2017. Eight patients with severe dysphonia attributable to vocal fold scarring associated with a congenital malformation or resulting from microsurgical sequelae (voice handicap index score >60 of 120) completed the study. Data analysis was performed from September 1, 2018, to January 1, 2019. Interventions: Injection of ADSVF into 1 or 2 vocal folds. Main Outcomes and Measures: The primary outcomes were feasibility and the number and severity of adverse events associated with ADSVF-based therapy. The secondary outcomes were changes in vocal assessment, videolaryngostroboscopy, self-evaluation of dysphonia, and quality of life at 1, 6, and 12 months after cell therapy. Results: Seven women and 1 man (mean [SD] age, 44.6 [10.4] years) were enrolled in this study. Adverse events associated with liposuction and ADSVF injection occurred; most of them resolved spontaneously. One patient received minor treatment to drain local bruising, and another experienced a minor contour defect at the liposuction site. At 12 months, the voice handicap index score was improved in all patients, with a mean (SD) improvement from baseline of 40.1 (21.5) points. Seven patients (88%) were considered to be responders, defined as improvement by 18 points or more in the voice handicap index score (the minimum clinically important difference). Conclusions and Relevance: The findings suggest that autologous ADSVF injection in scarred vocal folds is feasible and tolerable. The findings require confirmation in a randomized clinical trial with a larger population. Trial Registration: ClinicalTrials.gov Identifier: NCT02622464.

Lower rates of lipofilling sessions in latissimus dorsi flap breast reconstruction with initial higher volume transfer by preservation of subfascial fat: A 3D camera-assisted volumetric case series.

Breast reconstruction with latissimus dorsi flap (LDF) is a well-known technique, but the crucial goal is to achieve a satisfying final volume restoration. Our hypothesis is that LDF reconstruction with the preservation of subfascial fat can achieve a higher volume in a one-time procedure than that achieved in a classic LDF harvest. The aim of the study was to quantify the volume resorption in LDF reconstructions with the preservation of subfascial fat. Fifteen breasts were reconstructed with a simple LDF and the remaining 15 with an LDF with the preservation of the subfascial fat between January 2016 and May 2017. Secondly, every patient underwent a lipofilling procedure. A supplemental lipofilling procedure was performed in unsatisfying cases. A Structure-Sensor camera manufactured by OccipitalⓇ was used. Each patient received a 3D measurement during immediate postoperative care and then after 3 and 6 months of follow-up. This study shows no difference in volume retention at follow-up between the 2 techniques. The gain of an immediate and stable fatty layer in LDF + subfascial fat technique leads to breast volume improvement in one surgical step. Breast reconstruction with LDF and subfascial fat can be defined as a reliable solution, which provides an optimal result with a reduced number of surgical interventions when compared with a simple LDF.

The Use of Higher Proportions of Platelet-Rich Plasma to Enrich Microfat Has Negative Effects: A Preclinical Study.

BACKGROUND: Platelet-rich plasma improves engraftment after fat transfer. However, the effects of platelet dose have never been investigated. The authors used magnetic resonance imaging to compare surviving graft volumes in mice after administration of four different formulations (microfat alone, and three platelet-rich plasma-enriched microfat mixes). METHODS: The authors used a random, double-blinded, fat transfer protocol using three different platelet levels: 1 million (low-dose), 500 million (medium-dose), and 1000 million (high-dose) platelets/ml, and fat alone (control). The authors grafted 0.4 ml of the 70/30 platelet-rich plasma-enriched microfat mixtures (0.4 million, 200 million, and 400 million platelets per 0.12 ml for the low-dose, medium-dose, and high-dose mixtures, respectively) or 0.4 ml of microfat alone into 22 nude mice and monitored surviving graft volumes every month for 3 months. Then, the authors histologically analyzed all grafts to assess neoangiogenesis status and fat integrity. RESULTS: Three-dimensional magnetic resonance imaging showed that the median surviving graft volumes at 3 months were 9.5 percent (interquartile range, 0 to 25 percent; p = 0.003) (high-dose), 4.1 percent (interquartile range, 0 to 18 percent; p = 0.001) (medium-dose), and 18 percent (interquartile range, 8 to 38 percent; p = 0.41) (low-dose) compared to 36 percent (interquartile range, 28 to 53 percent) for the control value. The histologic integrity of microfat-alone grafts was significantly better than those of the other grafts, although the high-dose and low-dose grafts exhibited higher levels of neoangiogenesis. CONCLUSION: Higher platelet levels in microfat grafts were associated with poor graft survival in nude mice; a clinical review would be appropriate.