Impact of implant metal type and vancomycin prophylaxis on postoperative spine infection: an in-vivo study.

PURPOSE: To evaluate the effectiveness of vancomycin prophylaxis on spinal implant metal types. METHODS: 42 rabbits underwent posterior, single-level instrumentation at L5-L6 with stainless steel (n = 18), cobalt chrome (n = 12), or titanium (n = 12) wire. All implants were inoculated with 1 × 106 colony forming units (CFU) of methicillin-resistant S. Aureus (MRSA). In the intrawound vancomycin subgroup (n = 18, 6 from each metal type), 40 mg of vancomycin powder was placed in the wound. In the IV vancomycin subgroup (n = 6, all stainless steel), 15 mg/kg of IV vancomycin was given preoperatively. Local soft tissue and implants were harvested 1-week postoperatively and separately cultured. RESULTS: Intrawound vancomycin significantly reduced the rate of soft tissue infection (44.4% vs 100%) and implant infection (27.8% vs 100%) (p < 0.001). Within the intrawound vancomycin subgroup, cobalt chrome implants were associated with higher median soft tissue MRSA growth (130 CFU) than stainless steel (0 CFU) or titanium (0 CFU) (p = 0.02). Cobalt chrome implants were also more likely to develop soft tissue MRSA infection (83.3%) as compared to stainless steel (16.7%) or titanium (33.3%) (p = 0.04). Median soft tissue MRSA growth among stainless steel implants without prophylaxis, with IV vancomycin, and with vancomycin powder was 1.18 × 107, 195, and 0 CFU, respectively. The rate of soft tissue MRSA infection without prophylaxis, with IV vancomycin, and with vancomycin powder was 100, 66.7, and 16.7%, respectively (p = 0.015). CONCLUSION: Intrawound vancomycin is more effective than IV vancomycin and effectively reduces the risk of infection, but is less effective in cobalt chrome implants due to residual soft tissue infection.

Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery.

BACKGROUND: Surgical site infection is a morbid, devastating complication after spinal procedures. Studies have investigated the effect of wound lavage with 3.5% Povidone-iodine solution or the use of intrawound Vancomycin powder. We examined the effect of Povidone-iodine irrigation, intrawound Vancomycin powder, or a combination of both agents in a tertiary care Pediatric Hospital. METHODS: We queried our health system database for patients undergoing spinal surgery over an eight-year span between January 2008 and June 2016 and identified patient cohorts who received no intervention, intrawound Vancomycin alone, Povidone-iodine irrigation alone, or a combination of both agents. Infection rates were determined. The effect of treatment on outcome was analyzed using a logistic regression model. RESULTS: 475 patients were identified who met study inclusion criteria. 88 non-neuromuscular patients received no intra-operative agent. The surgical site infection (SSI) rate in this group of patients was 10%. For the 194 non-neuromuscular scoliosis patients who received Povidone-iodine and Vancomycin powder, the infection rate was reduced to 0.7%. The SSI rate in the 180 non-neuromuscular patients who were treated with Vancomycin powder alone was 1.4%. 13 patients were treated with Povidone-iodine lavage only, with a small sample size precluding statistical comparison. Infection rate in the 132 neuromuscular disease patients decreased from 14 to 7% overall during this time span: while the odds ratio of infection was reduced in all neuromuscular treatment groups receiving intra-operative measures, statistical significance was not reached in any neuromuscular group studied. CONCLUSIONS: A protocol using combined 3.5% weight/volume Povidone-iodine and Vancomycin powder was associated with the lowest infection rate in our non-neuromuscular patient population and should be considered as a low cost intervention in pediatric patients undergoing spinal deformity procedures. LEVEL OF EVIDENCE: Level II.

Risk Factors Associated With Complications After Treatment of Mandible Fractures.

IMPORTANCE: Complications that arise after treatment of mandible fractures can result in significant morbidity. Identifying modifiable risk factors associated with these complications is valuable in guiding clinical practice for improved patient outcomes. OBJECTIVE: To describe the risk factors associated with complications in patients undergoing treatment for mandible fracture. DESIGN, SETTING, AND PARTICIPANTS: A retrospective review was conducted of 137 patients presenting to a tertiary care, level 1 trauma center with mandible fractures between January 1, 2014, and January 1, 2017. Outcomes and demographic characteristics for patients with at least 3 weeks of follow-up were compared using multivariate logistic regression analysis. RESULTS: Of the 137 patients meeting inclusion criteria, there were 113 males (82.5%) and 24 females (17.5%), with a mean (SD) age at presentation of 32.3 (15.7) years. Median follow-up was 71 days (range, 22-1189 days). Postoperative complications were identified in 29 patients (21.2%); complications included wound dehiscence or surgical site infection (n = 17), bony nonunion (n = 5), and hardware exposure (n = 13). Complications were managed surgically in 19 patients and nonsurgically in 10 patients. On univariate analysis, the initial surgery was completed later (mean [SD], 5.9 [6.6] days after injury) in patients who developed complications than in those who did not (mean [SD], 3.8 [4.0] days). On multivariate analysis, complications were associated with increased time from injury to treatment (odds ratio [OR], 1.60; 95% CI, 1.02-2.53; P = .04), tobacco use (OR, 8.10; 95% CI, 1.26-52.00; P = .03), and dental extraction (OR, 93.00; 95% CI, 1.19 to >999.00; P = .04). Residence in the same city as the medical center was associated with fewer complications (OR, 0.08; 95% CI, 0.01-0.69; P = .02). CONCLUSIONS AND RELEVANCE: In a 3-year review of mandible fractures managed at a single academic center, complications were associated with an increased time to treatment, tobacco use, dental extraction, and living farther from the treatment facility. On a systems level, the results of this study suggest that expediting intervention for mandible fractures may improve outcomes. LEVEL OF EVIDENCE: 3.

Joint-specific risk of impaired function in fibrodysplasia ossificans progressiva (FOP).

BACKGROUND: Fibrodysplasia ossificans progressiva (FOP) causes progressive disability due to heterotopic ossification from episodic flare-ups. Using data from 500 FOP patients (representing 63% of all known patients world-wide), age- and joint-specific risks of new joint involvement were estimated using parametric and nonparametric statistical methods. RESULTS: Compared to data from a 1994 survey of 44 individuals with FOP, our current estimates of age- and joint-specific risks of new joint involvement are more accurate (narrower confidence limits), based on a wider range of ages, and have less bias due to its greater comprehensiveness (captures over three-fifths of the known FOP patients worldwide). For the neck, chest, abdomen, and upper back, the estimated hazard decreases over time. For the jaw, lower back, shoulder, elbow, wrist, fingers, hip, knee, ankle, and foot, the estimated hazard increases initially then either plateaus or decreases. At any given time and for any anatomic site, the data indicate which joints are at risk. CONCLUSIONS: This study of approximately 63% of the world's known population of FOP patients provides a refined estimate of risk for new involvement at any joint at any age, as well as the proportion of patients with uninvolved joints at any age. Importantly, these joint-specific survival curves can be used to facilitate clinical trial design and to determine if potential treatments can modify the predicted trajectory of progressive joint dysfunction.

Association of Velopharyngeal Insufficiency With Quality of Life and Patient-Reported Outcomes After Speech Surgery.

IMPORTANCE: Patients with cleft palate and other causes of velopharyngeal insufficiency (VPI) suffer adverse effects on social interactions and communication. Measurement of these patient-reported outcomes is needed to help guide surgical and nonsurgical care. OBJECTIVES: To further validate the VPI Effects on Life Outcomes (VELO) instrument, measure the change in quality of life (QOL) after speech surgery, and test the association of change in speech with change in QOL. DESIGN, SETTING, AND PARTICIPANTS: Prospective descriptive cohort including children and young adults undergoing speech surgery for VPI in a tertiary academic center. Participants completed the validated VELO instrument before and after surgical treatment. MAIN OUTCOMES AND MEASURES: The main outcome measures were preoperative and postoperative VELO scores and the perceptual speech assessment of speech intelligibility. The VELO scores are divided into subscale domains. Changes in VELO after surgery were analyzed using linear regression models. VELO scores were analyzed as a function of speech intelligibility adjusting for age and cleft type. The correlation between speech intelligibility rating and VELO scores was estimated using the polyserial correlation. RESULTS: Twenty-nine patients (13 males and 16 females) were included. Mean (SD) age was 7.9 (4.1) years (range, 4-20 years). Pharyngeal flap was used in 14 (48%) cases, Furlow palatoplasty in 12 (41%), and sphincter pharyngoplasty in 1 (3%). The mean (SD) preoperative speech intelligibility rating was 1.71 (1.08), which decreased postoperatively to 0.79 (0.93) in 24 patients who completed protocol (P < .01). The VELO scores improved after surgery (P<.001) as did most subscale scores. Caregiver impact did not change after surgery (P = .36). Speech Intelligibility was correlated with preoperative and postoperative total VELO score (P < .01) and to preoperative subscale domains (situational difficulty [VELO-SiD, P = .005] and perception by others [VELO-PO, P = .05]) and postoperative subscale domains (VELO-SiD [P = .03], VELO-PO [P = .003]). Neither the VELO total nor subscale score change after surgery was correlated with change in speech intelligibility. CONCLUSIONS AND RELEVANCE: Speech surgery improves VPI-specific quality of life. We confirmed validation in a population of untreated patients with VPI and included pharyngeal flap surgery, which had not previously been included in validation studies. The VELO instrument provides patient-specific outcomes, which allows a broader understanding of the social, emotional, and physical effects of VPI. LEVEL OF EVIDENCE: 2.

The Natural History of Flare-Ups in Fibrodysplasia Ossificans Progressiva (FOP): A Comprehensive Global Assessment.

Fibrodysplasia ossificans progressiva (FOP) leads to disabling heterotopic ossification (HO) from episodic flare-ups. However, the natural history of FOP flare-ups is poorly understood. A 78-question survey on FOP flare-ups, translated into 15 languages, was sent to 685 classically-affected patients in 45 countries (six continents). Five hundred patients or knowledgeable informants responded (73%; 44% males, 56% females; ages: 1 to 71 years; median: 23 years). The most common presenting symptoms of flare-ups were swelling (93%), pain (86%), or decreased mobility (79%). Seventy-one percent experienced a flare-up within the preceding 12 months (52% spontaneous; 48% trauma-related). Twenty-five percent of those who had received an intramuscular injection reported an immediate flare-up at the injection site, 84% of whom developed HO. Axial flare-ups most frequently involved the back (41.6%), neck (26.4%), or jaw (19.4%). Flare-ups occurred more frequently in the upper limbs before 8 years of age, but more frequently in the lower limbs thereafter. Appendicular flare-ups occurred more frequently at proximal than at distal sites without preferential sidedness. Seventy percent of patients reported functional loss from a flare-up. Thirty-two percent reported complete resolution of at least one flare-up and 12% without any functional loss (mostly in the head or back). The most disabling flare-ups occurred at the shoulders or hips. Surprisingly, 47% reported progression of FOP without obvious flare-ups. Worldwide, 198 treatments were reported; anti-inflammatory agents were most common. Seventy-five percent used short-term glucocorticoids as a treatment for flare-ups at appendicular sites. Fifty-five percent reported that glucocorticoids improved symptoms occasionally whereas 31% reported that they always did. Only 12% reported complete resolution of a flare-up with glucocorticoids. Forty-three percent reported rebound symptoms within 1 to 7 days after completing a course of glucocorticoids. This study is the first comprehensive global assessment of FOP flare-ups and establishes a critical foundation for the design and evaluation of future clinical trials.

Reducing surgical site infection in spinal surgery with betadine irrigation and intrawound vancomycin powder.

STUDY DESIGN: Retrospective analysis. OBJECTIVE: The objective of this study was to evaluate the efficacy of a surgical site infection (SSI) prevention protocol instituted in the Orthopaedic Spine Department at our institution. SUMMARY OF BACKGROUND DATA: SSI is an undesired complication of orthopedic spine surgical procedures. It poses a significant risk to the patient, as well as a financial toll on the health care system. A wide range of prophylactic measures have been used to attempt to reduce SSI rates. METHODS: A protocol consisting of a combination of 0.3% Betadine wound irrigation and 1 g of intrawound Vancomycin powder application was developed at our institution. Multiple data sources were consolidated for thorough evaluation of changes in SSI rates, patient risk factors, and changes in bacteriology. Identification of risk factors that predispose patients to SSI was performed using mixed-effects logistic regression in a univariate fashion. Risk factors with P values of 0.05 or less in univariate analysis were included together in a multivariate mixed-effects logistic regression model. RESULTS: SSI rates were reduced by 50% after the intervention; χ analysis comparing the SSI rates between the pre- and postintervention periods yielded a P value of 0.042. Rates of methicillin-resistant Staphylococcus aureus dropped from 30% to 7% and the rates of multibacterial infections dropped from 37% to 27%. The risk factors that were statistically significant in multivariate analysis were the following: age (odds ratio [OR] = 0.93), anemia (OR = 30.73), prior operation (OR = 27.45), and vertebral fracture (OR = 22.22). CONCLUSION: The combination of Betadine wound irrigation and intrawound vancomycin powder application led to both a clinically and statistically significant decrease in SSI rates by 50%. Bacteriology analysis and risk factor assessment proved to be valuable tools in assessing the efficacy of a new prophylactic measure and in the planning of future protocols. LEVEL OF EVIDENCE: 4.

Comparison of effectiveness of silicone gel sheeting with microporous paper tape in the prevention of hypertrophic scarring in a rabbit model.

OBJECTIVE: To determine the effectiveness of treating scars with microporous paper tape or silicone gel sheeting (SGS) in preventing hypertrophic scarring. METHODS: Forty hypertrophic scars were induced in a validated rabbit ear model. Wounds were randomized and bandaged for 30 days with either SGS (20 wounds), paper tape (20 wounds), or untreated controls (40 wounds). Two outcome measures of hypertrophic scarring included (1) histologic measurement of scar elevation index (SEI) and (2) blinded photograph analysis using a visual analog scale. RESULTS: In histologic comparison, no difference in mean (SE) SEI between treatment groups was seen (paper tape group, 1.32 [0.2]; SGS group, 1.41 [0.18]; control, 1.35 [0.23]; P = .51). In photographic analysis, both treatment groups were superior to the control group (P < .01), whereas no difference was seen between the SGS and paper tape groups (P = .88). CONCLUSIONS: Paper tape and SGS demonstrated equal effectiveness in the prevention of hypertrophic scarring on visual analysis, whereas histologic analysis demonstrated no difference in treatment groups from controls. The effectiveness of paper tape in preventing hypertrophic scarring in humans will require further laboratory and clinical investigation.