Evaluation of a novel anastomotic device in the animal model: A feasibility, safety, and efficacy study.

BACKGROUND: A novel device was designed to assist with microvascular arterial anastomoses. This study compares the safety and efficacy of the anastomosis-assisting device with manual suturing in an ovine model. METHODS: Arteries with a diameter ranging from 2 to 4 mm were transected and anastomosed at four locations. A comparison was done between manual anastomoses and anastomoses performed with a novel anastomotic device in seven sheep. All the device-assisted anastomoses were performed by a single surgeon. At day 45 ± 7, anastomotic sites were dissected to determine patency, and samples were obtained for pathology. RESULTS: Thirteen of 13 (100%) samples from the Vesseal™ group demonstrated patency both on the day the anastomoses were performed and after the 45-day follow-up period. All four additional anastomoses performed using the Vesseal™ were found patent. In the hand-suturing group, six of six (100%) samples demonstrated patency on the day of the anastomoses and five of six (83%) were patent after the follow-up period. No thromboses or adverse events were observed in the anastomoses in either group. No difference in histopathology of the anastomoses was observed between the groups. CONCLUSIONS: The anastomosis-assisting device is a safe and efficacious alternative to hand suturing. The patency rates of device-assisted anastomoses were greater than those of manual suturing and pose no additional risk, as demonstrated by clinical observation, histopathology, and macroscopic evaluation. The Vesseal™ anastomosis-assisting device may be a viable alternative to manual suturing, with an ergonomic and intuitive design, short learning curve, and consistent results.

The impact of statins on wound healing: an ally in treating the highly comorbid patient.

OBJECTIVE: To identify the impact that HMG-CoA reductase inhibitors (statins) use has on wound healing outcomes in patients with comorbidities. METHOD: A retrospective chart review evaluating all new patients presenting to our tertiary wound care centre in 2013 with lower extremity wounds. Patients were divided into two groups depending on whether they took statins or not. Data on wound healing outcomes and wound/patient characteristics were collected. Primary outcomes included healing rate and progression to complete wound healing. Patients were excluded if they had incomplete data or were lost to follow-up before healing status could be confirmed. RESULTS: A total of 194 patients met the inclusion criteria and were allocated to either the statin group (n=89) or to the non-statin group (n=105). Median initial wound size was 0.6cm3 (Interquartile range (IQR): 0.15-2.4) (p=0.684). In the statin group, 54 (60.6%) patients progressed to complete wound healing compared with 47 (44.7%) in the non-statin group (p=0.027). Median rate of wound healing was 6.7×10-3cm3/day (IQR: 1.5×10-3-2.6×10-2) compared with 3.8×10-3cm3/day (IQR: 1.7×10-3-1.3×10-2) in the non-statin group (p=0.773). Increased age and a higher number of comorbidities were reported in the statin group (p<0.001), respectively). A total of seven patients required amputation: five patients in the statin group and two patients in the non-statin group (p=0.250). CONCLUSION: This study revealed increased progression to wound healing in patients who were taking statins. The influence of statins on wound healing is promising, but future trials are needed to justify use of this medication class independent of cardiovascular benefit and exclusively for wound healing.

Pregnancy Reverses Abdominoplasty Aesthetic Outcome: Myth or Misconception? A Cross-Sectional Study.

BACKGROUND: The common recommendation for female abdominoplasty candidates is to conclude family planning before undergoing the procedure. However, no evidence demonstrates a correlation between aesthetic outcome compromise, risk for fetal complications, or risk for maternal complications when abdominoplasty is followed by pregnancy. OBJECTIVES: The aim of this study was to evaluate maternal, fetal, and aesthetic outcomes among pregnant females with a history of abdominoplasty. METHODS: The authors conducted an online survey among women who became pregnant after having an abdominoplasty. Participants were recruited via social media groups related to abdominoplasty. The survey included demographic-, aesthetic outcome-, and pregnancy-related questions utilizing a score from 1 (no effect) to 10 (worst effect) to assess abdominal aesthetic outcome compromise. RESULTS: Thirty-two participants completed the online survey, 15 (46.8%) of which reported their pregnancy was unplanned. Pregnancy-related findings included 5 (15.6%) late premature births (between gestational week 35 and 37), 1 miscarriage, and 1 emergency C-section. Compromised aesthetic outcomes following pregnancy included new abdominal stretch marks (50%, N = 16), widened abdominoplasty scar (28%, N = 9), abdominal skin excess (37.5%, N = 12), and abdominal bulge (25.8%, N = 8). A new hernia was reported by 2 participants (6.3%). The average abdominal aesthetic severity score was 2.7 (range, 1-8), and only 3 scores were above 5 (9.3%). Two women (6.2%) underwent abdominoplasty revision, and 18 (56.2%) stated they would recommend others to undergo abdominoplasty before pregnancy (56.3%). CONCLUSIONS: This survey shows there is room to reevaluate whether future pregnancy should be considered a relative contraindication for undergoing abdominoplasty.

Optimizing Throughput in Clinical Practice: Lean Management and Efficient Care in Plastic and Reconstructive Surgery.

BACKGROUND: As the cost of health care continues to rise, the role of medical providers has evolved to include the duties of an operations manager. Two theories of operations management can be readily applied to health care-lean management, the process of identifying and eliminating waste; and Little's law, the idea that throughput is maximized by changing the capacity to host patients or the time they spend in the system. Equipped with theories of operations management, providers are better able to identify and address flow limitations in their own practices. METHODS: Operations flow data were collected from three areas of care-clinic, surgical booking, and the operating room-for one provider. Variables of interest included visit or procedure characteristics and operations flow characteristics, such as different time points involved in the sector of care. RESULTS: Clinic data were collected from 48 patients. Variables with a significant relationship to total clinic visit time included afternoon appointments (p = 0.0080) and visit type (p = 0.0114). Surgical booking data were collected for 127 patients. Shorter estimated procedure length (p = 0.0211) decreased time to surgery. Operating room data were collected for 65 cases. Variables with a significant relationship to total operating room time were patient age (p = 0.0325), Charlson Comorbidity Index (p = 0.0039), flap type (p = 0.0153), and number of flaps (p < 0.0001). CONCLUSIONS: This brief single-provider study provides examples of how to apply operations management theories to each point of care within one's own practice. Although longitudinal data following patients through each point of care are the next step in operations flow analysis, this work lays the foundation for evaluation at each time point with the goal of developing practical strategies to improve throughput in one's practice.

A Novel Recombinant Human Collagen-based Flowable Matrix for Chronic Lower Limb Wound Management: First Results of a Clinical Trial.

BACKGROUND: Chronic ulcers pose a significant health concern and economic burden. Numerous products, including animal-derived collagen products, have been designed to provide the injured site with a biocompatible structural matrix that promotes tissue regeneration. Yet, animal-derived collagens can evoke immune responses, bear risk of disease transmission, and fail to closely mimic the function of native collagen. OBJECTIVE: This study aims to assess the safety and performance of a novel flowable wound matrix, formulated from tobacco plant-purified fibrillated recombinant human type I collagen (rhCollagen), in patients with chronic lower limb ulcers. MATERIALS AND METHODS: This single-arm, open-label, multicenter trial took place at 5 treatment centers. Wounds were photographed and preliminary surgical debridement was performed prior to rhCollagen application. Patients received a single application of rhCollagen to the wound bed, followed by weekly assessments of the wound. RESULTS: Twenty patients (mean age, 63 years), presenting with a chronic ulcer of neuropathic (45%), posttraumatic (35%), postoperative (10%), and venous (10%) origin, underwent rhCollagen treatment. Initial wound area ranged between 0.2 cm3 to 9.2 cm3. At 4-weeks posttreatment, median wound area reduction was 94%. Fifteen ulcers exhibited ≥ 70% wound closure, 9 of which achieved complete closure. Only 1 participant suffered a local self-resolving wound infection. No significant device-related adverse events were reported throughout the study. CONCLUSIONS: A single, easy-to-use rhCollagen flowable gel application for chronic lower limb ulcers may promote wound closure with minimal adverse events.

Sub-muscular plane for augmentation mammoplasty patients increases silicone gel implant rupture rate.

BACKGROUND: Breast augmentation is one of the most common aesthetic procedures performed worldwide. One of the worst associated complications is implant rupture, a topic that will be addressed in the present study. The risk of developing silicone gel breast implant rupture following breast augmentation is associated with multiple factors, including: older generation implant, increased implant age, implant type, specific manufacturer, severe capsular contracture (Baker grade III or IV), and the presence of local symptoms. We hypothesize that the plane of the implant placement may also play a role in the development of implant rupture due to differences in opposing forces upon the implant between submuscular and subglandular planes. OBJECTIVES: To assess the effect of potential risk factors on breast prosthesis rupture rate, focusing on implant pocket selection, capsular contracture and implant volume. METHODS: A retrospective cohort study was performed on patients with silicone breast implants in either subglandular or submuscular plane, who underwent an elective breast implant exchange, with or without mastopexy, between January 2012 and June 2017. Data collected included patient's age, implant age, implant pocket, implant volume, capsular contracture grade, and implant status (ruptured or intact). RESULTS: Data was collected on 362 women (700 breasts). A total of 284 women (542 breasts) met the inclusion criteria. The average age of the subjects was 43.4 ±â€¯10.4 years. Average implant age during exchange was 10 ±â€¯6.1. There was no difference between the characteristics of the submuscular group and the subglandular group, except from patient age. In a univariant analysis, patient's age (46.4 vs. 41.8, p < 0.001) and implant age (12.2 vs. 8.92 years, p < 0.001) were associated with significantly higher rupture rate. Among ruptured implants, the relative proportion of submuscular to subglandular implants was 64%, compared to 48% among non-ruptured implants (p < 0.0001). When controlling for potential confounders, submuscular pocket (OR = 0.1835, CI95% 1.25-2.69, p = 0.002) as well as implant size (OR = 1.004, CI95% 1.001-1.007, p = 0.005) were found to be a risk factor for implant rupture. CONCLUSION: A sub-muscular implant pocket was identified as a significant risk factor for implant rupture. The prevailing theory that larger size implant carries an increased risk of complications, is also reinforced in this study. Large prospective studies are needed to further clarify risk factors for implant rupture.

Preoperative Implant Size Is Strongly Associated With Alternations of Implant Size During Secondary Breast Augmentation.

BACKGROUND: Breast augmentation is one of the most popular cosmetic surgeries performed worldwide. In turn, there has been an increasing number of secondary breast augmentation procedures in recent years. Implant selection at secondary breast augmentation can be a challenge and is affected by a number of factors. The aim of this study was to assess the main factors affecting the decision-making process with regard to implant volume determination prior to implant exchange. METHODS: Women who underwent elective breast implant exchange between 2012 and 2016 were included in this study. Medical records were used to acquire implant and patient data. The patient's desires, as well as medical considerations, were taken into account during the implant selection process. RESULTS: Two hundred forty-five women with an average age of 43 years (range, 21-69 years) were included in the study. The mean time between primary augmentation and implant exchange was 10 ± 5.7 years. Overall, 192 implants (38.9%) were exchanged with larger implants, 84 implants (17%) were exchanged with smaller implants, and 218 implants (44.1%) were exchanged with implants similar to the preoperative size (±25 mL). In patients who received smaller implants, the mean reduction in implant volume was found to be 78.88 mL. Women were more likely to receive a smaller implant during implant exchange if the preoperative implant volume was larger than 367 mL (P = 0.00006). Among patients who received larger implants, no correlation was found between preoperative and postoperative implant size. A positive correlation was found between the implant age and a reduction in implant size (P = 0.036). However, no correlation was found between the patient's age and the decision to reduce or enlarge implant size upon revision. CONCLUSIONS: Almost half of patients receive similarly sized implants during elective implant exchange. Among those who did decide to change their implant size, more than twice as many patients opted for a larger implant as opposed to a smaller one. Relatively large preoperative implant size and longer time since primary augmentation were associated with the selection of smaller implants during exchange. Further studies should be conducted to reinforce these results.

Poly Implants Prosthèse Breast Implants: A Case Series and Review of the Literature.

BACKGROUND: Silicone breast implants from the French manufacturer Poly Implants Prosthèse (PIP) were recalled from the European market after the French regulator has revealed the implants contain non-medical-grade silicone filler. In December 2011, following a large increase in reported rupture rate and a possible cancer risk, the French Ministry of Health recommended consideration of the PIP explantation, regardless of their condition. In 2012, the Israel Ministry of Health recommended to replace the implants only upon suspected implant rupture. OBJECTIVES: The aims of this study were to characterize breast-augmented Israeli patients with PIP implants, compare their outcomes with those of breast-augmented patients with different implant types, and review the current PIP literature. METHODS: Breast-augmented patients who underwent an elective breast implant exchange in Israel between January 2011 and January 2017 were included in the study. Data were collected from electronic and physical medical files. RESULTS: There were 73 breast-augmented female patients with 146 PIP breast implants included in this study. Average implant age was 6.7 ± 2.79 years. Mean implant size was 342.8 ± 52.9 mL. Fourteen women (19 implants [16%]) had a high-grade capsular contracture (Baker grade 3-4). During exchange, 28 implants were found to be ruptured (19.2%). CONCLUSIONS: Less than 10 years following breast augmentation, PIP implants demonstrated higher rupture rate compared with other implants. Our data are comparable to overall available rupture rate. Among patients with definitive rupture diagnosis, an elective implant removal should be recommended. In cases of undamaged implants, plastic surgeons should also seriously consider PIP implant explantation. When the patient does not desire to remove the implant, an annual physical examination and breast ultrasound are recommended, beginning a year after augmentation.

Accuracy of malignant melanoma detection in the community.

Malignant melanoma (MM) has increased profoundly in the past three-four decades in white populations worldwide. Early diagnosis is crucial for successful treatment. We aimed to assess the accuracy rate of diagnosing MM in the community by the surgeon and referring physicians. We prospectively collected data on all patients with preoperatively suspected or histologically proven MM, treated by a single plastic surgeon, between October 2001 and April 2005. Data were statistically analyzed using Excel software. Of the 50 patients with histopathologically proven MM, 74% were referred by dermatologists, 16% by primary caregivers, and 10% came independently or were under supervision of the operating plastic surgeon. Eighty percent MM lesions were early-stage, under 1 mm. Forty lesions were diagnosed clinically as MM by the plastic surgeon prior to surgery. Dermatologists diagnosed MM in only 30% of cases; the other 70% were referred for removal of suspect lesions. Dermatologists referred most MM cases. The high number of patients diagnosed with early stage MM (80%) reflects the efficiency of medical care in our community. We conclude that the diagnosis of MM in our community is efficient and derives from the balanced partnership between surgeons, dermatologists, primary caregivers, and patient awareness.

The loss of pathological specimens: incidence and causes.

BACKGROUND: Tissue biopsy loss can have devastating clinical and legal consequences. OBJECTIVE: To evaluate the incidence and cause of tissue biopsy loss. METHODS & MATERIALS: The study followed biopsy specimens taken by one plastic surgeon in an outpatient clinic between October 2001 and April 2005. Four thousand two hundred minor surgical procedures were performed, and 4,400 biopsy specimens were sent to pathology. In case of specimen loss, a formal investigation was performed. RESULTS: Five specimens were reported as lost during the period. Two were retrieved, two were lost probably because of failure to insert the pathology specimen into the container, and one was lost in the pathology laboratory during processing. Overall incidence of specimen loss was 1 in 1,466 (0.068%). CONCLUSIONS: In this study, we identified the critical point of specimen loss to be noninsertion of the specimen into the container by medical staff. To prevent future errors at this critical point, strict guidelines such as immediate insertion of the specimen into the container and signing on the container confirming that the specimen is in the correct labeled container at the end of the procedure are recommended.

[Diagnostic accuracy of skin lesions excised by a plastic surgeon].

BACKGROUND: Skin tumors are the most common malignancies in the western population, with surgical excision as the definitive treatment. OBJECTIVES: The author's objectives were to estimate the precision of clinical diagnosis of skin tumors by a plastic surgeon in a community clinic. METHODS: The study includes clinical and histological data of patients operated on solely by one plastic surgeon, between November 2001 to July 2003. The sensitivity and positive predictive value were measured and compared to the literature. RESULTS: The study included 1640 patients. Out of 1806 excised skin lesions, 17.4% were malignancies. Basal cell carcinoma was the most common tumor, followed by squamous cell carcinomas and melanomas. Sensitivity for skin malignancy was 94%, and 76.5% for specific skin malignancy. Positive predictable value for any malignancy was 69.4%, and 72% for the basal cell carcinoma, the most common skin malignancy. CONCLUSIONS: Clinical examination is the main diagnostic tool for the plastic surgeon and dermatologist in the evaluation of skin lesions. Surgical excision is considered when clinical diagnosis is not productive or when malignancy is suspected. For most malignancies, diagnostic excision is therapeutic as well. Positive predictable value is a prospective index estimating the clinical diagnostic skills of the clinician. In our opinion, new technologies such as dermatoscopy should be used more often in the evaluation of skin lesions.

Lack of complications in minor skin lesion excisions in patients taking aspirin or warfarin products.

Many patients undergoing surgical procedures take medications that influence the coagulation system. It is common practice to discontinue the use of aspirin and warfarin products 7 to 10 days before any major surgical procedure. However, there is some controversy as to whether these medications should be discontinued for minor dermatological procedures. Our aim was to study the incidence of complications in patients receiving aspirin or warfarin and undergoing minor dermatological procedures. Two thousand three hundred twenty-six patients, operated on by a single surgeon, were studied for complications. Warfarin was used by 28 patients, 228 took aspirin, and the remainder took neither. There was no difference in the complication rate among the three groups as long as the surgeon diligently obtained hemostasis. It appears that patients taking aspirin or warfarin do not need to discontinue these medications before minor dermatological procedures.