Simulating the IMA Recipient Site for DIEP Flap Surgery: A New Model for Dynamic Microsurgery Simulation with Real-Time Respiration and a Pilot Study.

BACKGROUND: Breast reconstruction (BR) using autologous free flaps has been shown to have numerous psychosocial and quality-of-life benefits. Unfortunately, the microsurgical learning curve is quite steep due to some unique operative challenges. Currently, there is no realistic simulation model that captures real-life respiratory excursion and the depth of internal mammary vessels within the compact recipient site. The purpose of this study was to delineate intraoperative measurements of depth and motion, describe the resulting simulation model, and conduct a pilot study evaluating the simulator as an educational resource. METHODS: This is a single-center, ethics-approved study. For the intraoperative measurements, all consecutive patients undergoing free flap BR using internal mammary vessels as recipients were recruited. Patient and intraoperative factors as well as intraoperative measurements were recorded. A dynamic model was developed based on intraoperative parameters. For the pilot study, plastic and reconstructive surgery trainees were recruited to complete a hand-sewn internal mammary artery (IMA) anastomosis using the new simulator and completed objective questionnaires pre- and postsimulation. Subjective feedback was recorded and themes determined. RESULTS: Fifteen operative sites were analyzed. Flap pocket was found to be between 4 and 5 cm in depth with vertical excursion of 3.7 ± 1.0mm and a respiratory rate of 9 to 14 breaths/minute. Previous radiation, rib space, body mass index (BMI), blood pressure, heart rate, tidal volume, and respiratory rate showed no correlation to vessel depth/excursion. Laterality, rib space, BMI, radiation, vitals, and tidal volume had no correlation with vessel movement. Twenty-two trainees were included in the pilot. An increase in confidence and mixed results for anxiety was reported. CONCLUSION: This study reports a novel microsurgical simulation model that provides a realistic deep inferior epigastric perforator free flap BR IMA anastomosis experience. It replicates movement of vessels in situ with real-time respiratory excursion and similar physical structures of the internal mammary system. This model shows promising results for increased use in microsurgical education.

Determining the Independent Risk Factors for Worse SCAR-Q Scores and Future Scar Revision Surgery.

BACKGROUND: Scar revisions have been increasing in number. Patient-reported outcome measures are one tool to aid scar modulation decision-making. The aims of this study were to determine patient, scar, and clinical risk factors for (1) low SCAR-Q Appearance, Symptom, and Psychosocial Impact scores and how this differs for children; and (2) the potential need for future scar revision surgery to better identify such patients in a clinical setting. METHODS: A multicenter international cross-sectional cohort study based on survey data of participants with traumatic, surgical, and burn scars attending plastic, hand, and burn clinics in four countries was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology checklist. Univariate analysis to identify risk factors and multivariable logistic analysis to select risk factors were completed. Collinearity for nonindependent factors and C statistic for model discrimination were also calculated. RESULTS: Seven hundred thirty-one participants completed the study booklet, and 546 participants (74.7 percent) had full data. Independent risk factors were determined to be a bothersome scar and perception of scarring badly for all three scales. Risk factors for self-reporting the need for future surgery included a health condition, scarring badly, scar diagnosis, prior scar revision, and low Psychosocial Impact scores. We did not identify evidence of multicollinearity. C statistics were high (0.81 to 0.84). CONCLUSIONS: This study is the first multicenter international study to examine independent risk factors for low patient-reported outcome measure scores and the potential need for future scar revision surgery. Patients that perceive themselves as scarring badly and having a bothersome scar were at a higher risk of scar appearance concern, an increased symptom burden, and poorer psychosocial impact scores. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Psychometric Findings for the SCAR-Q Patient-Reported Outcome Measure Based on 731 Children and Adults with Surgical, Traumatic, and Burn Scars from Four Countries.

BACKGROUND: Each year, millions of individuals develop scars secondary to surgery, trauma, and/or burns. Scar-specific patient-reported outcome measures to evaluate outcomes are needed. To address the gap in available measures, the SCAR-Q was developed following international guidelines for patient-reported outcome measure development. This study field tested the SCAR-Q and examined its psychometric properties. METHODS: Patients aged 8 years and older with a surgical, traumatic, and/or burn scar anywhere on their face or body were recruited between March of 2017 and April of 2018 at seven hospitals in four countries. Participants answered demographic and scar questions, the Fitzpatrick Skin Typing Questionnaire, the Patient and Observer Scar Assessment Scale (POSAS), and the SCAR-Q. Rasch measurement theory was used for the psychometric analysis. Cronbach's alpha, test-retest reliability, and concurrent validity were also examined. RESULTS: Consent was obtained from 773 patients, and 731 completed the study. Participants were aged 8 to 88 years, and 354 had surgical, 184 had burn, and 199 had traumatic scars. Analysis led to refinement of the SCAR-Q Appearance, Symptoms, and Psychosocial Impact scales. Reliability was high, with person separation index values of 0.91, 0.81, and 0.79; Cronbach alpha values of 0.96, 0.91, and 0.95; and intraclass correlation coefficient values of 0.92, 0.94, and 0.88, respectively. As predicted, correlations between POSAS scores and the Appearance and Symptom scales were higher than those between POSAS and Psychosocial Impact scale scores. CONCLUSIONS: With increasing scar revisions, a scar-specific patient-reported outcome measure is needed to measure outcomes that matter to patients from their perspective. The SCAR-Q represents a rigorously developed, internationally applicable patient-reported outcome measure that can be used to evaluate scars in research, clinical care, and quality improvement initiatives.

Timing of Presentation of Pediatric Compartment Syndrome and Its Microsurgical Implication: A Retrospective Review.

BACKGROUND: Pediatric forearm compartment syndrome can lead to severe functional disability. Although it is known that earlier presentation with decompression leads to better outcomes, it is not known when presentation after injury leads to significant loss of function requiring microsurgical intervention. The authors describe the rate of microsurgical reconstruction after pediatric forearm compartment syndrome as related to timing of presentation. METHODS: A retrospective chart review was conducted of pediatric patients with forearm compartment syndrome between January 1, 2000, and March 22, 2013, after a traumatic upper extremity injury. Demographic information, cause, time to decompression, complications, and functional outcome were recorded. RESULTS: Thirty-five patients aged between 2 and 16 years (8.97 ± 4.12 years) met inclusion criteria. The majority (74 percent) were boys. The right upper extremity was predominantly involved (54 percent), with a predilection for ulnar fractures (66 percent). Fasciotomies were completed for 32 patients (91 percent). Two patients had no decompression (6 percent) because of late presentation. The average time to fasciotomy was less than 12 hours after injury in 16 patients (46 percent), 12 to 48 hours in 15 patients (43 percent), and greater than 48 hours in four patients (11 percent). Complications (63 percent) included nerve injury (40 percent), skin graft (37 percent), scar revision (11 percent), and long flexor tightness requiring serial casting (17 percent). Forearm muscle necrosis requiring microsurgical reconstructive surgery with a gracilis muscle flap occurred in two patients (6 percent). Increased time to decompression was statistically associated with long flexor tightness and gracilis reconstructive surgery. CONCLUSION: Presentation after 48 hours resulted in significant functional deficits requiring reconstructive surgery (gracilis muscle flap reconstruction) or long-term conservative management (serial casting).

A Systematic Review of Surgical Randomized Controlled Trials: Part I. Risk of Bias and Outcomes: Common Pitfalls Plastic Surgeons Can Overcome.

BACKGROUND: The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions. METHODS: An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias. RESULTS: Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001). CONCLUSIONS: This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

BACKGROUND: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. METHODS: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. RESULTS: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). CONCLUSIONS: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Safety of tissue expander/implant versus autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients: a systematic review and meta-analysis.

BACKGROUND: Breast reconstruction after mastectomy for breast cancer should be informed by evidence-based knowledge, such as complication rates. The authors compared the safety of tissue expander/implant reconstruction with that of autologous abdominal tissue reconstruction. METHODS: A systematic literature review identified peer-reviewed studies published from January of 2000 to October of 2012 that compared tissue expander/implant against autologous abdominal tissue reconstruction in the MEDLINE, EMBASE, Cochrane Library, PubMed, and ProQuest Dissertations and Theses databases. Two reviewers independently screened all reports and selected the relevant articles using specific inclusion criteria. Data were extracted from the relevant articles using a standardized abstraction form. RESULTS: Fourteen observational studies were identified that included more than 3000 reconstructed breasts. Significant differences were found between these two approaches. The relative risk associated with reconstructive failure favored autologous abdominal tissue (relative risk, 0.14; 95 percent CI, 0.06 to 0.32; I = 0 percent). Surgical-site infection was significantly lower in autologous abdominal tissue reconstruction compared with tissue expander/implant (relative risk, 0.37; 95 percent CI, 0.25 to 0.55; I = 0 percent), although skin or flap necrosis was higher in autologous abdominal tissue reconstruction compared with tissue expander/implant (relative risk, 2.79; 95 percent CI, 1.87 to 4.17). Studies were of low to moderate quality according to the Newcastle-Ottawa scale. CONCLUSIONS: This study suggests that tissue expander/implant reconstruction has a higher risk of reconstructive failure and surgical-site infection compared with autologous abdominal tissue reconstruction. With the lack of long-term safety studies on different approaches to breast reconstruction, additional long-term comparative studies are needed to support evidence-based decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Systematic review of economic evaluations in plastic surgery.

BACKGROUND: Economic evaluations are quantitative methods comparing alternative interventions using cost data and expected outcomes. They are used to recommend/dissuade adoption of new surgical interventions and compare different clinical pathways, settings (inpatient/outpatient), or time horizons to determine which procedure may be more cost-effective. The objective of this systematic review was to describe all published English economic evaluations related to a plastic surgery domain. METHODS: A comprehensive English literature review of the MEDLINE, EMBASE, The Cochrane Library, Health Economic Evaluations Database, Ovid Health Star, and Business Source Complete databases was conducted (January 1, 1986, to June 15, 2012). Articles were assessed by two independent reviewers using predefined data fields and selected using specific inclusion criteria. Extracted information included country of origin, journal, and date of publication. Domain of plastic surgery and type of economic evaluation were ascertained. RESULTS: Ninety-five articles were included in the final analysis, with cost analysis being the most common economic evaluation (82 percent). Full economic evaluations represented 18 percent. General cutaneous disorders/burns (24 percent), breast surgery (20 percent), and "multiple" (15 percent) were the top domains studied. Authors were predominantly based in the United States (56 percent) and published in the journal Plastic and Reconstructive Surgery (22 percent), with a significant proportion (40 percent) published in the last 5 years. CONCLUSIONS: Partial economic assessments (cost analyses) with limited benefit represent the majority of economic evaluations in plastic surgery. This suggests an urgent need to alert plastic surgeons to the advantages of full economic evaluations (cost-effectiveness and cost utility analyses) and the need to perform such rigorous analyses.