Reporting bias in breast reconstruction clinical trials: Which and when clinical trials get published.

BACKGROUND: Reporting bias refers to the phenomenon in which the reporting of research findings is influenced by the nature of the results. Without the totality of evidence, clinical practice may be misguided. The objective of this work was to examine the extent of reporting bias in clinical trials of breast reconstruction surgery. METHODS: We searched and extracted data from all completed breast reconstruction clinical trials published in ClinicalTrials.gov from database inception to August 2020. Investigators sought to identify published full manuscripts of the registered trials. The primary outcome was classified as positive or nonpositive and trials were classified as industry or nonindustry funded. Time to publication in a peer-reviewed journal was computed and compared using time-to-event analysis. Trial characteristics associated with publication were evaluated using logistic regression. RESULTS: A total of 156 clinical trials were identified, of which, 53 trials were published. The median time to publication was 22 months (IQR, 13-35 months). Industry-funded studies were associated with a longer time to publication (HR = 2.4, p = 0.023) and publication in lower-impact journals (OR = 3.7, p = 0.048). Randomized clinical trials were associated with faster times to publication than nonrandomized studies (aHR = 3.2, p = 0.030). Statistical significance and the effect size were not associated with time to publication. CONCLUSIONS: We found no evidence that industry-funded trials were more likely to report a positive primary outcome. However, industry-funded trials were associated with a longer time to publication and publication in lower-impact journals.

The Effects of Tranexamic Acid in Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: Tranexamic acid (TXA) is used in trauma and surgical settings. Its role in reducing postoperative blood loss in breast surgery remains unclear. The primary objective of this study was to determine the effect of TXA on postoperative blood loss in breast surgery. METHODS: Searches of the PubMed, Ovid MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases were performed from inception to April 3, 2020. Inclusion criteria were any retrospective reviews, prospective cohort studies, and randomized controlled trials that administered TXA (topical or intravenously) in the context of breast surgery. Quality of studies were evaluated using the risk of bias in randomized trials tool and the risk of bias in nonrandomized studies of interventions tool. Data were pooled, and a meta-analysis was performed. RESULTS: In total, seven studies were included, representing 1226 patients (TXA, 632 patients; control, 622 patients). TXA was administered as follows: topically (20 mL of 25 mg/mL TXA intraoperatively; n =258 patients), intravenously (1 to 3 g perioperatively; n = 743 patients), or both (1 to 3 g daily up to 5 days postoperatively; n = 253 patients). TXA administration reduced hematoma formation in breast surgery (risk ratio, 0.48; 95% CI, 0.32 to 0.73), with no effect on drain output (mean difference, -84.12 mL; 95% CI, -206.53 to 38.29 mL), seroma formation (risk ratio, 0.92; 95% CI, 0.60 to 1.40), or infection rates (risk ratio, 1.01; 95% CI, 0.46 to 2.21). No adverse effects were reported. CONCLUSION: The use of TXA in breast surgery is a safe and effective modality with low-level evidence that it reduces hematoma rates without affecting seroma rates, postoperative drain output, or infection rates.

A comparison of skin grafts versus local flaps for facial skin cancer from the patient perspective: protocol for a feasibility study.

BRIEF ABSTRACT: This is a protocol to assess feasibility of conducting a prospective cohort study comparing local flaps versus skin grafts for surgical excision of skin cancer from the face. INTRODUCTION: Skin cancer is the most common malignancy worldwide and the face is one of the most common locations of occurrence. Surgical excision is the most popular treatment for small lesions of the face. Defects can be reconstructed using local flaps or skin grafts. There is a paucity of literature evaluating outcomes after skin cancer surgery from the patient's perspective using valid measurement tools. The purpose of this study is to assess the feasibility of conducting a prospective observational cohort study. The primary outcomes include recruitment rates, eligibility rate, compliance of intervention and rate of completion of the primary outcome (FACE-Q scales) at 3 months. Secondary outcomes include examining patient characteristic and FACE-Q score differences between local flaps to skin grafts and adverse events. METHODS AND ANALYSIS: This study is a prospective cohort study consisting of an anticipated 30 patients aged ≥18 years. The study population will consist of a consecutive sample of non-melanoma facial skin cancer patients undergoing a skin graft or local flap. Patients will be followed and evaluated with the FACE-Q questionnaire at 2 weeks, 3 months, 6 months and 1 year post-operation. The following criteria will determine success: patients who meet eligibility criteria >70%; recruitment rate >70%; compliance with intervention >90%; rate of completion of full-scale prospective study primary outcome (FACE-Q at 3 months) >80%; retention rate at 6-month follow-up visit >70%. DISCUSSION: The findings of this study will be used to guide the sample size calculation for a future, large-scale prospective study.Trial registration: ClinicalTrials.gov (NCT04842279).

Immobilization of the Wrist After Dorsal Wrist Ganglion Excision: A Systematic Review and Survey of Current Practice.

BACKGROUND: Postoperative care after dorsal wrist ganglion (DWG) excision is highly varied. The effect of immobilization of the wrist on patient outcomes has not yet been examined. METHODS: A systematic review of the literature was performed to determine whether wrist immobilization after DWG surgical excision is beneficial. A survey of hand surgeons in Canada was performed to sample existing practice variations in current immobilization protocols after DWG excision. RESULTS: A systematic review yielded 11 studies that rigidly immobilized the wrist (n = 5 open excision, n = 5 arthroscopic excision, n = 1 open or arthroscopic excision), 10 studies that used dressings to partially limit wrist motion (n = 5 open, n = 5 arthroscopic), 1 study (open) that did either of the above, and 2 studies (arthroscopic) that did not restrict wrist motion postoperatively. This ranged from 48 hours to 2 weeks in open DWG excision and 5 days to 3 weeks in arthroscopic DWG excision. The survey of Canadian hand surgeons had a similarly divided result of those who chose to immobilize the wrist fully (41%), partially (14%), or not at all (55%). Most surgeons surveyed who immobilized the wrist postoperatively did so for 1 to 2 weeks. CONCLUSION: The systematic review and survey of Canadian hand surgeons reveal that hand surgeons are divided regarding the need to immobilize the wrist after DWG excision. In terms of functional outcome, there is no compelling data to suggest 1 strategy is superior. The time frame for immobilization when undertaken was short at 2 weeks or less.The systematic review is registered in the PROSPERO database (PROSPERO 2016:CRD42016050877).

Identification of the anatomy of the deep temporal vein using computed tomography imaging: A retrospective cross-sectional review of patient imaging.

PURPOSE: The deep temporal vein (DTV) can be used in free flap procedures when the superficial temporal vein is inadequate. Despite its potential utility, its branching patterns have only been examined in one small anatomic study. The purpose of this study was to examine computed tomography angiography (CTA) images to determine DTV location, variation, and suitability as a microvascular recipient, to provide surgeons with a guide for its use in head and neck defects. METHODS: A retrospective chart review identified 152 patient CTA images (76 female; 76 male) in a single academic center imaging database, selected consecutively from January 2017 to April 2020. Patients under 19 years were excluded; ages ranged from 19 to 80 years (average 51.6 years). Reason for imaging, DTV caliber, laterality, distance to zygomatic arch (ZA [coronal and sagittal]), distance to lateral orbital rim (LOR), and branching pattern were recorded. RESULTS: The predominant reason for imaging was to rule out cerebrovascular accident (96.2%). Average caliber was 3.46 ± 1.29 mm (95% confidence interval [CI] [3.32, 3.61]; range, 1.00-10.8). Bilateral DTVs were observed in 98.7% of patients. Average distance to landmarks were as follows: ZA (coronal), 13.8 ± 5.85 mm (95% CI [13.2, 14.5]; range, 2.7-33.8); ZA (sagittal), 15.1 ± 6.12 mm (95% CI [14.1, 16.1]; range, 2.8-47.2); LOR, 47.1 ± 9.09 mm (95% CI [46.0, 48.1]; range, 10.8-62.9). Seven branching patterns were identified, including a posterior vertical variant that bypasses the superficial temporal fat pad. CONCLUSIONS: The DTV is a "lifeboat" option for head and neck reconstruction. Its average caliber is sufficient for use in microsurgery. Knowledge of both its typical and aberrant courses allow for efficient preoperative planning and surgical dissection. CTA is a useful adjunct when planning to use the DTV for free tissue transfer.

Outcomes in Facial Feminization Surgery: A Systematic Review.

Objective: Review literature on facial feminization surgery (FFS) for the transgender population and identify whether heterogeneity in reported outcomes and outcome measures exists across studies, as measured by a lack of consensus, and number of outcomes and outcome measures used. Evidence Review: A search of MEDLINE and EMBASE (database inception to January 20, 2021) was performed to retrieve FFS studies. Primary outcomes included number of reported outcomes and outcome measures; secondary outcomes included clinimetric properties of outcome measures and study characteristics. Findings: In total, 15 articles were included. Sixty-nine outcomes and 12 outcome measures were identified. Of those outcome measures, zero were found to be valid, reliable, and responsive in patients who had undergone FFS. A variety of FFS interventions were studied, with the three most common interventions being: rhinoplasty (n = 7, 46.7%), mandibuloplasty (n = 7, 46.7%), and chondrolaryngoplasty (n = 6, 40%). Conclusion and Relevance: Heterogeneity was evident in reported outcomes and outcome measures in FFS literature and there is currently no outcome measure commonly used for this patient population.

Isolated Medial Maxillary Buttress Displacement in Naso-Orbito-Ethmoid Fractures: A Surgical Indication to Resolve Nasal Airway Obstruction.

PURPOSE: The aim of this study was to present a case series emphasizing low medial maxillary (pyriform) buttress displacement in naso-orbito-ethmoid (NOE) fractures as an operative indication, in the absence of the typical NOE surgical indications (medial canthus displacement, midface bony comminution, nasal bone collapse, and orbital indications), to prevent nasal airway obstruction. METHODS: Five cases of minor NOE fractures are reviewed, where only the low medial maxillary buttress was displaced. The typical surgical indications for NOE repair were absent. RESULTS: In each case, the pyriform buttress was medially and posteriorly displaced, creating nasal airway obstruction in each patient. The medial canthal tendons were all nondisplaced, there was no diplopia, and the other 2 cardinal buttresses (infraorbital rim and nasofrontal junction) were minimally displaced or greensticked. In the acute setting, patients were treated with open reduction and internal fixation. With delayed presentation, septorhinoplasty or osteotomy and fixation were used. Among the patients who had adequate follow-up, nasal airway obstruction was resolved. CONCLUSIONS: This series suggests that, in NOE fractures with isolated displacement at the medial maxillary buttress, nasal airway obstruction should be considered an operative indication (independent of the classical indications) in order to prevent or resolve nasal airway obstruction.

Postmarket Modifications of High-risk Plastic Surgery Devices.

BACKGROUND: In the United States, high-risk medical devices must be cleared through the premarket approval (PMA) pathway, which requires clinical evidence ensuring safety and efficacy. Approved devices can be modified and reintroduced to market without additional study through the PMA supplemental review track. This study characterizes the changes of high-risk plastic surgery devices once they undergo initial clearance. METHODS: A retrospective, cross-sectional analysis of the Food and Drug Administration (FDA) PMA database. The following data were extracted from the PMA database (January 1, 1980 to December 31, 2018): initial clearance date, device type, the number and type of supplement, supplement reason, and product withdrawal date. Data from the FDA medical device recall database were also extracted and reported. The median number of device modifications and median lifetime of device-years were calculated. RESULTS: There have been 39 original plastic surgery devices approved by the FDA. There was no significant change with respect to initial clearance dates for original devices over time (r = 0.28; P = 0.084). PMA supplement usage has significantly increased with time (rs = 0.9174, P = 0.000). Overall, approved plastic surgery devices have undergone a median of 11 changes (IQR, 3-35). Breast implant devices collectively underwent the most modifications with a median of 28 modifications per device (IQR, 20.25-33.25). CONCLUSIONS: Over the past 2 decades, plastic surgery device manufacturers have significantly increased the use of supplement track review. High-risk plastic surgery devices may undergo frequent minor changes without clinical evidence to support the safety and efficacy of modified versions.

Carpal Tunnel Release without a Tourniquet: A Systematic Review and Meta-Analysis.

BACKGROUND: Open carpal tunnel release is commonly performed with the use of a tourniquet. The combination of local anesthetic and epinephrine with a pneumatic tourniquet helps provide clear visualization during decompression of the median nerve. There has been a rapid expansion of literature challenging the use of tourniquets in open carpal tunnel release. Consequently, the local anesthesia/no tourniquet approach has become increasingly popular. The authors evaluated the outcomes of awake open carpal tunnel release with and without a tourniquet. METHODS: The authors attempted to identify all relevant studies, regardless of language or publication status. A systematic database search for relevant studies was conducted in MEDLINE, EMBASE, EBSCO, and CENTRAL. Included studies compared patients undergoing awake open carpal tunnel release with and without an arm or forearm tourniquet. RESULTS: Eight studies evaluating 765 patients and 866 hands were included. Open carpal tunnel release with the wide awake, local anesthesia, no tourniquet approach resulted in a 2.14 point reduction on the visual analog scale (95% CI, 1.30 to 2.98; p < 0.001). The procedure was 1.82 minutes faster with the use of a tourniquet (95% CI, -3.26 to -0.39; p = 0.01). There were no significant differences between groups in intraoperative blood loss, surgeon perceived difficulty, and complications. CONCLUSION: This systematic review found that tourniquet use causes significantly more pain with no significant clinical benefit as compared with using a wide awake, no tourniquet approach in carpal tunnel decompression.

Reporting Outcomes and Outcome Measures in Open Rhinoplasty: A Systematic Review.

BACKGROUND: Comparative studies have shown little statistical difference in outcomes following rhinoplasty, demonstrating near equivalent results across all surgical techniques. Cross-study comparisons of these trials are difficult because variation in outcome reporting prevents statistical pooling and analysis. OBJECTIVES: The authors sought to identify all outcomes and outcome measures used to evaluate postoperative results in rhinoplasty. METHODS: An extensive computerized database search of MEDLINE and EMBASE was performed; all trials involving n ≥ 20 patients, aged 18 years and older undergoing a primary, open rhinoplasty procedure, were included for review. RESULTS: Of the 3235 citations initially screened, 72 studies met the stated inclusion criteria. A total of 53 unique outcomes and 55 postoperative outcome measures were identified. Outcomes were divided into 6 unique domains: objective signs, subjective symptom severity, physical function related to activities of daily living, patient satisfaction, surgeon satisfaction, and quality of life. The identified outcome measures consisted of 5 nasal-specific, author-reported instruments; 5 nasal specific, patient-reported instruments; 5 patient-reported, generic instruments; and 40 author-generated instruments. Of the outcome measures identified, the Rhinoplasty Outcomes Evaluation, Sino-Nasal Outcome Test-22, and FACE-Q were the only instruments to demonstrate adequate validity, reliability, and responsiveness to change in patients who underwent a rhinoplasty procedure. CONCLUSIONS: There is heterogeneity in the outcomes and outcome measures employed to assess postsurgical outcomes following rhinoplasty. A standardized core outcome set is urgently needed to make it possible for future investigators to compare results of various techniques in rhinoplasty surgery.

Use of negative-pressure wound therapy and split-thickness skin autograft to cover an exposed renal transplant.

Exposure of a renal transplant through the abdominal wall is a rare event. A search of the literature reveals only six documented cases which used skin autograft for coverage, with none reported since 1981, and none which used negative-pressure wound therapy (NPWT) to prepare the recipient bed. This case report demonstrates that NPWT followed by split thickness skin graft is a reconstructive option which is feasible in patients who are at high risk for surgical complications in prolonged flap surgery.

Microvascular lining options for subtotal and total nasal reconstruction: A scoping review.

BACKGROUND: Restoration of nasal lining is essential in reconstruction of subtotal/total nasal defects. When local flaps are inadequate, a microvascular flap should be used. The purpose of this scoping review is to map the literature and identify the described flap options for subtotal/total nasal reconstruction. Further to that, we will summarize the stated advantages and disadvantages, evaluate functional and esthetic outcomes, and appraise the current body of literature. METHODS: An electronic literature search was completed. Studies required adult patients with subtotal/total nasal defects and lining reconstruction with microvascular free flap. Two independent reviewers completed screening and data extraction. Flap characteristics, advantages, disadvantages, functional and esthetic outcomes were reviewed. Two independent reviewers evaluated study quality. RESULTS: Of 305 initial articles, 22 studies were included (13 case reports, 9 case series) accounting for 65 flaps. Microvascular flaps varied by composition and anatomical location. For functional outcome, 13 studies used clinical exam by surgeon, 5 reported patient being satisfied, 3 studies used endoscopy, and 1 study used nasometry. Assessing esthetic outcome, 13 studies used clinical exam by surgeon, 5 studies reported patient being satisfied, 1 study used patient-reported outcome measures, and 16 studies included photos. Study quality (modified CARE and PROCESS checklists) was deemed poor. Quality of available evidence was level IV. CONCLUSIONS: Microvascular free flaps for nasal reconstruction, confer an overall satisfactory functional and esthetic outcome. All studies lack a systematic and comprehensive approach to assessing and reporting these outcomes. Future research should provide objective assessment and utilize patient reported outcome measures.

A Shift on the Horizon: A Systematic Review of Assessment Tools for Plastic Surgery Trainees.

BACKGROUND: As plastic surgery programs transition toward competency-based medical education curricula, it is important to critically assess current methods of evaluating trainee competence. The purpose of this systematic review was to identify and evaluate assessment tools for technical and nontechnical competencies in plastic surgery. METHODS: A systematic search using keywords related to competency-based medical education, assessment, and plastic surgery was conducted. Two independent reviewers extracted data pertaining to study characteristics, study design, and psychometric properties. Data pertaining to the establishment of competence and barriers to tool implementation were noted. RESULTS: Twenty-three studies were included in this review. Technical competencies were assessed in 16 studies. Nontechnical competencies were assessed in five studies. Two studies assessed both technical and nontechnical competence. Six tools were implemented in a simulated setting and 17 tools were implemented in a clinical setting. Thirteen studies (57 percent) did not report reliability scores and nine (39 percent) did not report validity scores. Two tools established clear definitions for competence. Common barriers to implementation included high demands on resources and time, uncertainty about simulation transferability, and assessor burnout. CONCLUSIONS: A number of tools exist to assess a range of plastic surgery skills, in both clinical and simulated settings. There is a need to determine the transferability of simulated assessments to clinical practice, as most available tools are simulation-based. Although additional psychometric testing of current assessment tools is required, particularly in the nontechnical domain, this review provides a base on which to build assessment frameworks that will support plastic surgery's transition to competency-based medical education.

Long-term effect of primary cleft rhinoplasty on secondary cleft rhinoplasty in patients with unilateral cleft lip-cleft palate.

BACKGROUND: The senior author routinely performs primary nasal reconstruction with every cleft lip repair. This addresses the nasal tip asymmetry and simplifies the definitive secondary rhinoplasty in adolescence. METHODS: A retrospective chart review was completed of all unilateral cleft secondary rhinoplasties performed by the senior author. The indications for secondary rhinoplasty were examined, anatomical features of the nose at the time of operation were documented, and the reconstructive techniques used were recorded. RESULTS: From 2001 to 2009, the senior author performed 116 secondary rhinoplasties in patients with a previously repaired unilateral cleft lip. The senior author performed 44 of the initial cleft lip repairs (group A). A Dibbell rhinoplasty was required in 26 percent, a Potter rhinoplasty was required in 5 percent, a Tajima inverted-U incision was required in 70 percent, and an alar base resection was required in 53 percent. For those patients who did not undergo cleft lip repair with primary rhinoplasty by the senior author, 60 percent required a Dibbell rhinoplasty, Potter rhinoplasty was not used, 76 percent required a Tajima inverted-U incision, and 64 percent required an alar base resection. Group A had significantly greater dome symmetry when comparing the cleft side to the noncleft side (p = 0.001). Nostril apex height was also more symmetrical in group A (p = 0.105). CONCLUSION: Primary nasal reconstruction performed with cleft lip repair as described by the senior author makes the nasal tip more symmetric and requires less complex intervention at the time of definitive secondary rhinoplasty. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Prosthetic vascular graft infection: a multi-center review of surgical management.

A multi-center retrospective review of major prosthetic graft infection outcomes was undertaken to determine graft preservation and limb salvage rates. The management of infected prosthetic vascular grafts continues to be controversial. The purpose of this study was to review the surgical management of major extracavitary prosthetic vascular graft infections and to correlate the outcomes on the basis of bacteriology and grade. The change in patient population seen by vascular surgeons and the recent emergence of more virulent bacterial strains should influence surgical management. Bacteriology and severity of infection based on grade must play a greater role in the selection criteria for graft salvage. Despite advancement in the understanding of these interactions and the emergence of new management algorithms, we are continuing to operate without a uniform standard in managing this difficult and rapidly evolving clinical problem.