RESUMO
OBJECTIVES: International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital. DESIGN: Multicenter, open, parallel-group randomized feasibility trial. SETTING: Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals. PATIENTS: Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization. INTERVENTIONS: IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization. MEASUREMENTS AND MAIN RESULTS: Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean (sd) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% (n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83). CONCLUSIONS: Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.
RESUMO
INTRODUCTION: The fully synthetic skin substitute, NovoSorb Biodegradable Temporizing Matrix (BTM), may be a cost-effective alternative to the animal-derived Integra Dermal Regeneration Template (IDRT). However, the current literature insufficiently compares the two. Therefore, our study compared clinical, aesthetic, and economic outcomes in treating soft tissue wounds with IDRT, an animal-derived template, vs BTM, a fully synthetic template. METHODS: Our single-center retrospective study compared outcomes of 26 patient cases treated with BTM (57.7%) or IDRT (42.3%) during 2011-2022. RESULTS: The mean surgery time was significantly shorter in BTM cases (1.632 ± 0.571 hours) compared with IDRT cases (5.282 ± 5.102 hours, P = 0.011). Median postoperative hospital stay was notably shorter for BTM placement than IDRT placement (0.95 vs 6.60 days, P = 0.003). The median postoperative follow-up length approached a shorter duration in the BTM group (P = 0.054); however, median follow-up visits were significantly lower in the BTM group compared with the IDRT group (5 vs 14, P = 0.012). The median duration for complete wound closure was shorter for BTM (46.96 vs 118.91 days, P = 0.011). Biodegradable Temporizing Matrix demonstrated a notably lower infection rate (0.0%) compared with IDRT (36.4%, P = 0.022). Integra Dermal Regeneration Template exhibited higher wound hypertrophy rates (81.8%) than BTM (26.7%, P = 0.015). Revisionary surgeries were significantly more frequent in the BTM group (P < 0.001). Failed closure, defined as requiring one or more attempts, exhibited a significant difference, with a higher risk in the IDRT group (26.7%) compared with BTM (6.7%, P = 0.003). Biodegradable Temporizing Matrix showed a lower mean Vancouver Scar Scale adjusted fraction (0.279) compared with IDRT (0.639, P < 0.001). Biodegradable Temporizing Matrix incurred lower costs compared with IDRT but displayed a lower mean profit per square centimeter ($10.63 vs $22.53, P < 0.001). CONCLUSION: Economically, although the net profit per square centimeter of dermal template may favor IDRT, the ancillary benefits associated with BTM in terms of reduced hospital stay, shorter surgery times, fewer follow-up visits, and lower revisionary surgery rates contribute substantially to overall cost-effectiveness. Biodegradable Temporizing Matrix use reflects more efficient resource use and potential cost savings, aligning with broader trends in healthcare emphasizing value-based and patient-centered care.
Assuntos
Derme Acelular , Cirurgia Plástica , Animais , Humanos , Cicatrização , Estudos Retrospectivos , Estética , Transplante de PeleRESUMO
BACKGROUND: The importance of adaptable and up-to-date plastic surgery graduate medical education (GME) has taken on new meaning amidst accelerating surgical innovation and increasing calls for competency-based training standards. We aimed to examine the extent to which the procedures plastic surgery residents perform, as represented in case log data, align with 2 core standardized components of plastic surgery GME: ACGME (Accreditation Council for Graduate Medical Education) minimum procedure count requirements and the PSITE (Plastic Surgery In-Service Training Examination). We also examined their alignment with procedural representation at 2 major plastic surgery meetings. METHODS: Nine categories of reconstructive and aesthetic procedures were identified. Three-year averages for the number of procedures completed in each category by residents graduating in 2019-2021 were calculated from ACGME national case log data reports. The ACGME procedure count minimum requirements were also ascertained. The titles and durations of medical programming sessions scheduled for Plastic Surgery The Meeting (PSTM) 2022 and the Plastic Surgery Research Council (PSRC) Annual Meeting 2022 were retrieved from online data. Finally, test items from the 2020 to 2022 administrations of the PSITE were retrieved. Conference sessions and test items were assigned to a single procedure category when possible. Percent differences were calculated for comparison. RESULTS: The distribution of procedures on plastic surgery resident case logs differs from those of the major mechanisms of standardization in plastic surgery GME, in-service examination content more so than ACGME requirements. Meeting content at PSTM and PSRC had the largest percent differences with case log data, with PSTM being skewed toward aesthetics and PSRC toward reconstructive head and neck surgery. DISCUSSION: The criteria and standards by which plastic surgery residents are evaluated and content at national meetings differ from the procedures they actually complete during their training. Although largely reflecting heterogeneity of the specialty, following these comparisons will likely prove useful in the continual evaluation of plastic surgery residency training, especially in the preparation of residents for the variety of training and practice settings they pursue.
Assuntos
Cirurgia Geral , Internato e Residência , Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Humanos , Estados Unidos , Cirurgia Plástica/educação , Educação de Pós-Graduação em Medicina , Acreditação , Competência ClínicaRESUMO
BACKGROUND: The use of left ventricular assist devices (LVADs) for patients with end-stage cardiac failure awaiting heart transplantation has become increasingly common. However, ventricular assist device-related infections remain a major problem complicating their long-term use. Retrospective review has previously shown a decrease in lifetime return to operating room (RTOR) with no change in 90-day complications when a muscle or omental flap is used for coverage after washout for infection. We wished to determine if early plastic surgery intervention led to a decreased length of stay for these patients. METHODS: Patients with LVAD readmitted for LVAD infection at a single institution from 2008 to 2021 were identified using a preexisting database. Patients were followed retrospectively for an average of 3.2 years. Patient demographics, preoperative diagnosis/disease state, type of ventricular assist device inserted, postoperative day of ventricular assist device infection onset, definitive device coverage, timing of coverage procedure after the initial washout for infection, type of flap used for coverage, 90-day complications after definitive coverage, and lifetime return to operating room for infection were reviewed. Comparison analysis with χ2 and analysis of variance testing was used to analyze outcomes. RESULTS: Of 568 patients admitted with an LVAD infection, 104 underwent operative debridement and closure by plastic and reconstructive surgery (PRS) or cardiothoracic surgery (CTS). Fifty-three underwent PRS closure, and 51 underwent CTS closure. There was an increased incidence of diabetes among the PRS group (P < 0.001); otherwise, there was no difference in baseline characteristics. There was increased RTOR over a lifetime with CTS closure compared with PRS (P = 0.03) and increased 90-day risk of infection (P = 0.007). Patients with PRS closure had an increased risk of postoperative hematoma (P = 046). Plastic and reconstructive surgery was typically consulted on hospital day 10. Both PRS and CTS closure patients were discharged on postoperative day 7, on average (P = 0.542). CONCLUSIONS: Plastic surgery involvement with surgical decision making and closure of infected LVAD devices has a decrease in lifetime RTOR and decreased 90-day complications related to infections. There may be a benefit to earlier PRS consultation for coverage assessment.
Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Infecções Relacionadas à Prótese , Cirurgia Plástica , Humanos , Coração Auxiliar/efeitos adversos , Estudos Retrospectivos , Salas Cirúrgicas , Infecções Relacionadas à Prótese/etiologia , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/etiologia , Resultado do TratamentoRESUMO
INTRODUCTION: Both biologic and permanent (synthetic) meshes are used for abdominal wall reconstruction. Biologic mesh has the advantage of eventual incorporation, which makes it generally preferred in contaminated patients compared with synthetic mesh (Ann Surg. 2013;257:991-996). However, synthetic mesh has been shown to have decreased long-term hernia recurrence despite increased complications (JAMA Surg. 2022;157:293-301). Ovitex (TelaBio, Ltd, Auckland, New Zealand) is a combined reinforced biologic mesh with a permanent Prolene suture weave that theoretically combines incorporation with a long-term strength component. We hypothesize that a reinforced biologic will have a similar complication profile but decreased long-term hernia recurrence. METHODS: A single-center retrospective review was performed from January 2013 to January 2022. Baseline patient characteristics and outcomes including 90-day complications and recurrence were compared. Categorical and continuous variables were analyzed with χ2 and Wilcoxon rank sum tests, respectively. Predictors of postoperative complications and hernia recurrence were analyzed via univariate logistic regression and multivariate logistic regression with backward stepwise selection with a threshold of P < 0.2. RESULTS: Two hundred fifty-four patients underwent abdominal wall reconstruction biologic mesh (Strattice, Allergan; FlexHD, MTF Biologics; Alloderm, Allergan; Surgisis Gold, Cook Biotech; Ovitex, Telabio) with retrorectus (66.5%) or intraperitoneal (33.5%) mesh placement. Sixty-six of these used reinforced biologic mesh (Ovitex, TelaBio). Baseline characteristics were comparable including preoperative hernia size measured on CT. The mean follow-up time was 343 days. The majority of patients underwent component separation (80.3% bilateral, 11.4% unilateral, 8.3% none). On univariate analysis, reinforced biologic mesh did not impact 90-day complication rates (P = 0.391) or hernia recurrence rates (P = 0.349). On multivariate analysis, reinforced mesh had no impact on complication or recurrence rates (P > 0.2). A previous history of infected mesh was an independent risk factor for hernia recurrence (P = 0.019). Nonreinforced biologics were more likely to be used in instances of previous mesh infection (P = 0.025), bowel resection (P = 0.026), and concomitantly at the time of stoma takedown (P = 0.04). Reinforced biologics were more likely to be used with a history of previous hernia repair with recurrence not due to infection (P = 0.001). Body mass index >35 was an independent risk factor across both groups for 90-day complications (P = 0.028). CONCLUSIONS: Reinforced versus nonreinforced biologics have similar risk profile and recurrence rate when placed primary fascial repair achieved. In abdominal walls with history of infection, or abdominal wall reconstruction performed concomitantly at the time of stoma takedown or bowel resection/anastomosis, nonreinforced biologics were used more commonly with no difference in negative outcomes. This implies that they may have a role for use in contaminated surgical cases. Reinforced biologics were more commonly used as a mesh choice in the setting of previous hernia repair with recurrence with no difference in outcomes. This implies that the reinforced nature may be useful in situations where extra reinforcement of already traumatized abdominal wall tissue is needed. Retrorectus or intraperitoneal placement of any biologic mesh is acceptable and should be chosen based off surgeon comfort and anticipated cost saving of individual mesh brands. There may be a role for reinforced mesh in the setting of previous failed hernia repair with weakened fascia, as well as nonreinforced in contaminated cases.
Assuntos
Parede Abdominal , Produtos Biológicos , Hérnia Ventral , Humanos , Hérnia Ventral/cirurgia , Telas Cirúrgicas , Resultado do Tratamento , Parede Abdominal/cirurgia , Estudos Retrospectivos , Herniorrafia , Produtos Biológicos/uso terapêutico , RecidivaRESUMO
Fellowship program websites pertaining to various subspecialties have been evaluated according to the amount and type of content they communicate to prospective applicants. This study aimed to evaluate what information specifically burn fellowship programs communicate through their websites and to what extent, if at all. Ten of the 30 unique burn fellowship programs, American Burn Association (ABA)-verified or otherwise, identified through the ABA website did not have official websites which could be readily located at time of data collection. Thus, twenty burn fellowship program websites were included in analysis. Burn fellowship program websites were assessed according to 23 criteria relating to recruitment, education, and social life. On average, each website contained an average of 8.5 ± 2.6 criteria (range, 2 - 13), with all of them listing a program contact email/phone, and 95% containing a program description. Only 35% of programs listed the faculty, and a single program advertised alumni job placement. Neither total number of fellows, total number of clinical faculty, nor Accreditation Council for Graduate Medical Education accreditation status were significantly associated with amount or type of content. Geographic region was associated with a significant difference in amount of education-related content. Fellowship program websites are important to prospective applicants when comparing programs and deciding where to apply. These results show where burn fellowship programs can increase the amount of publicly-available information that applicants tend to find helpful in order to hopefully both diversify and tailor their applicant pool to those whose goals align with the programs'.
RESUMO
BACKGROUND: Traumatic insults, infection, and surgical procedures can leave skin defects that are not amenable to primary closure. Split-thickness skin grafting (STSG) is frequently used to achieve closure of these wounds. Although effective, STSG can be associated with donor site morbidity, compounding the burden of illness in patients undergoing soft tissue reconstruction procedures. With an expansion ratio of 1:80, autologous skin cell suspension (ASCS) has been demonstrated to significantly decrease donor skin requirements compared with traditional STSG in burn injuries. We hypothesized that the clinical performance of ASCS would be similar for soft tissue reconstruction of nonburn wounds. METHODS: A multicenter, within-patient, evaluator-blinded, randomized-controlled trial was conducted of 65 patients with acute, nonthermal, full-thickness skin defects requiring autografting. For each patient, two treatment areas were randomly assigned to concurrently receive a predefined standard-of-care meshed STSG (control) or ASCS + more widely meshed STSG (ASCS+STSG). Coprimary endpoints were noninferiority of ASCS+STSG for complete treatment area closure by Week 8, and superiority for relative reduction in donor skin area. RESULTS: At 8 weeks, complete closure was observed for 58% of control areas compared with 65% of ASCS+STSG areas (p = 0.005), establishing noninferiority of ASCS+STSG. On average, 27.4% less donor skin was required with ASCS+ STSG, establishing superiority over control (p < 0.001). Clinical healing (≥95% reepithelialization) was achieved in 87% and 85% of Control and ASCS+STSG areas, respectively, at 8 weeks. The treatment approaches had similar long-term scarring outcomes and safety profiles, with no unanticipated events and no serious ASCS device-related events. CONCLUSION: ASCS+STSG represents a clinically effective and safe solution to reduce the amount of skin required to achieve definitive closure of full-thickness defects without compromising healing, scarring, or safety outcomes. This can lead to reduced donor site morbidity and potentially decreased cost associated with patient care.Clincaltrials.gov identifier: NCT04091672. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level I.