Faculty Bibliography

This study presents a systematic review of randomized controlled trials (RCTs) in cleft and craniofacial surgery. All studies reporting on RCTs in cleft and craniofacial surgery were identified on PubMed using the search terms "cleft," "velopharyngeal insufficiency," "velopharyngeal dysfunction," "nasoalveolar molding," "gingivoperiosteoplasty," "Pierre Robin sequence," "craniofacial," "craniosynostosis," "craniofacial microsomia," "hemifacial microsomia," "hypertelorism," "Le Fort," "monobloc," "distraction osteogenesis," "Treacher Collins," and "Goldenhar." Studies were excluded if they were not randomized, did not focus primarily on topics related to cleft or craniofacial surgery, included repeat publications of data, or were unavailable in English. Studies were evaluated on demographic and bibliometric data, study size, specific area of focus, and findings reported. Four hundred forty-seven unique studies were identified. One hundred eighty-three papers met inclusion criteria (115 cleft lip and palate, 65 craniofacial, and 3 spanning both disciplines). Sixty-six (36%) were dedicated to topics related to surgical techniques. There were no studies comparing current cleft lip or soft palate repair techniques and no studies on cleft rhinoplasty. The most frequently reported surgical topic was cleft palate. There were several studies on orthognathic techniques which compared distraction osteogenesis to traditional advancement. Most craniofacial operations, such as cranial vault remodeling and frontofacial advancement/distraction, were not represented. Several standard operations in cleft and craniofacial surgery are not supported by Level I evidence from randomized controlled trials. Our community should consider methods by which more RCTs can be performed, or redefine the acceptable standards of evidence to guide our clinical decisions.

PURPOSE/OBJECTIVE:Cerebrospinal fluid diversion via ventricular shunt is a common treatment for hydrocephalus. Change in cranial morphology associated with a sutural fusion has been termed shunt-related or induced craniosynostosis (SRC) or craniocerebral disproportion (CCD). We present a series of patients with SRC who underwent cranial vault remodeling (CVR) and our treatment algorithm. METHODS:Thirteen patients were retrospectively reviewed who had SRC and CVR; 92% of patients had a ventriculoperitoneal (VP) shunt placed for largely intraventricular hemorrhage of prematurity (69% of patients) at a mean age of 2.2 months. The shunt revision rate was 38.4%, and 54% of patients had a programmable shunt placed initially. RESULTS:The mean age at time of CVR was 3.6 years old. The most commonly affected sutures (CT confirmed) were the sagittal and coronal sutures, with three patients exhibiting pancraniosynostosis. The mean time from placement of the shunt to CT evidence of sutural fusion was 2.0 years. Abnormal head shape was noted in all 13 patients; 11 of these also had either chronic headaches, papilledema, seizures, or behavioral changes in the setting of functional shunt. Mean follow-up after the initial CVR was 3.3 years. No shunt infections were attributed to the CVR. The families of all patients were contacted and reported improvement in head shape with 60% of families reporting improvement in behavior, 75% reported improvement in headaches, and 40% reported decrease in seizure frequency or intensity. Shunt setting or type was not routinely changed after CVR. CONCLUSIONS:Our threshold for CVR in SRC is met when shunt malfunction has been ruled out and there are (1) radiographic evidence of craniosynostosis, (2) signs of increased ICP clinically or radiographically, and (3) cranial dysmorphism, i.e., dolichocephaly. The majority of cases of SRC result in improved cranial morphology in addition to some abatement of the symptoms of increased intracranial pressure. Early involvement of an experienced craniofacial/neurosurgical team could allow for early diagnosis and intervention which may prevent progression to more severe deformities. SRC is a complex entity, with multiple etiologies, and a future study is needed.

BACKGROUND:Vascularized bone tissue transfer, commonly used to reconstruct large mandibular defects, is challenged by long operative times, extended hospital stay, donor-site morbidity, and resulting health care. 3D-printed osseoconductive tissue-engineered scaffolds may provide an alternative solution for reconstruction of significant mandibular defects. This pilot study presents a novel 3D-printed bioactive ceramic scaffold with osseoconductive properties to treat segmental mandibular defects in a rabbit model. METHODS:Full-thickness mandibulectomy defects (12 mm) were created at the mandibular body of eight adult rabbits and replaced by 3D-printed ceramic scaffold made of 100% β-tricalcium phosphate, fit to defect based on computed tomography imaging. After 8 weeks, animals were euthanized, the mandibles were retrieved, and bone regeneration was assessed. Bone growth was qualitatively assessed with histology and backscatter scanning electron microscopy, quantified both histologically and with micro computed tomography and advanced 3D image reconstruction software, and compared to unoperated mandible sections (UMSs). RESULTS:Histology quantified scaffold with newly formed bone area occupancy at 54.3 ± 11.7%, compared to UMS baseline bone area occupancy at 55.8 ± 4.4%, and bone area occupancy as a function of scaffold free space at 52.8 ± 13.9%. 3D volume occupancy quantified newly formed bone volume occupancy was 36.3 ± 5.9%, compared to UMS baseline bone volume occupancy at 33.4 ± 3.8%, and bone volume occupancy as a function of scaffold free space at 38.0 ± 15.4%. CONCLUSIONS:3D-printed bioactive ceramic scaffolds can restore critical mandibular segmental defects to levels similar to native bone after 8 weeks in an adult rabbit, critical sized, mandibular defect model.

BACKGROUND:Patients' satisfaction is an increasingly important indicator for successful ear reconstruction surgeries. However, there is no scientifically sound patient-based outcome instrument in this field. This study aims at developing a patient-reported outcome measure for microtia reconstruction for investigating patients' satisfaction and perception of reconstructed ear and clinical researches. METHODS:The development of questionnaire included 3 stages. Traditional psychometric tests were used for analysis. At first stage, a preliminary version of the questionnaire was developed using qualitative methods, including interviews with 10 patients. At second stage, the questionnaire was field tested by survey of 76 patients. Redundant items were deleted; acceptability, reliability, and responsiveness were examined. At third stage, survey was conducted to another 94 patients with the shortened questionnaire to further evaluate the acceptability, reliability, and validity. RESULTS:A questionnaire of 12 items for microtia reconstruction was developed. Results demonstrated the instrument satisfied the current criteria. The acceptability (missing data <1%, largest endorsement frequencies <60%), reliability (Cronbach alphas >0.80, item-total correlations >0.7, interitem correlation <0.8), validity (scale intercorrelations r = 0.59, low correlations with age and sex) of the questionnaire. CONCLUSIONS:The questionnaire is an acceptable, reliable, and validated outcome measure for evaluation of ear reconstruction esthetic outcomes in microtia patients. It could be used for further comparison studies and effectiveness studies.

Postburn lip deformities pose a significant set of challenges to reconstructive burn surgeons because of the complex anatomy, diverse functions, and specialized nature of the lip tissues. There has been a paucity of literature on restoration of the vermillion to date. The authors report on two patients who suffered burn injuries resulting in significant lip deformities who underwent a novel method of vermillion reconstruction with a full thickness anal verge skin graft. Both patients tolerated the procedure well without complications. One patient had slight hyperpigmentation of the graft which was treated with a phenol peel to cause intentional lightening. Overall, both patients had a restored vermillion border and improved color match and contour of the lip. Histologic analysis of the anal verge demonstrates that it has a nonkeratinized, transitional epithelial architecture which is nearly identical to that of the vermillion tissue. Skin grafting remains one of the cornerstones of tissue replacement in acute burn care and burn reconstruction. The vermillion represents an area of specialized tissue that is not well reconstructed with simple skin grafts. Other methods for reconstruction involve lip switch operations or local flaps, like a ventral tongue flap. These procedures are not without limitation and can often cause microstomia among other issues. With no donor site morbidity, a full thickness anal verge skin graft represents the closest approximation of actual vermillion tissue found anywhere else in the body and should be considered a viable option in the reconstruction of these challenging patients.

BACKGROUND:Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. METHODS:We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. DISCUSSION:Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality. TRIAL REGISTRATION:NCT03136367 at ClinicalTrials.gov Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.