Characterizing Clinical Trials in Plastic and Reconstructive Surgery: A Systematic Review of ClinicalTrials.gov From 2007 to 2020.

BACKGROUND: Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov. METHODS: Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting. RESULTS: A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87). CONCLUSIONS: A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight.

The Golden Hour After Injury Among Civilians Caught in Conflict Zones.

INTRODUCTION: The term "golden hour" describes the first 60 minutes after patients sustain injury. In resource-available settings, rapid transport to trauma centers within this time period is standard-of-care. We compared transport times of injured civilians in modern conflict zones to assess the degree to which injured civilians are transported within the golden hour in these environments. METHODS: We evaluated PubMed, Ovid, and Web of Science databases for manuscripts describing transport time after trauma among civilian victims of trauma from January 1990 to November 2017. RESULTS: The initial database search identified 2704 abstracts. Twenty-nine studies met inclusion and exclusion criteria. Conflicts in Yugoslavia/Bosnia/Herzegovina, Syria, Afghanistan, Iraq, Israel, Cambodia, Somalia, Georgia, Lebanon, Nigeria, Democratic Republic of Congo, and Turkey were represented, describing 47 273 patients. Only 7 (24%) manuscripts described transport times under 1 hour. Transport typically required several hours to days. CONCLUSION: Anticipated transport times have important implications for field triage of injured persons in civilian conflict settings because existing overburdened civilian health care systems may become further overwhelmed if in-hospital health capacity is unable to keep pace with inflow of the severely wounded.

Where Do We Look? Assessing Gaze Patterns in Cosmetic Face-Lift Surgery with Eye Tracking Technology.

BACKGROUND: Aesthetics plays a central role in determining success in plastic surgery. Understanding perceptions of favorable aesthetics is critical to ensure patient satisfaction. Eye-tracking technology offers an objective way of evaluating attention and understanding how viewers direct their focus on patients who undergo cosmetic face-lift procedures. METHODS: Thirty-six subjects ranging from layperson to attending plastic surgeon viewed 15 sets of photographs before and after patients underwent an elective face-lift procedure. They were instructed to evaluate the aesthetic quality on a Likert scale while eye-tracking equipment tracked their gaze and analyzed their distribution of attention. RESULTS: Postoperative images showed a Likert score improvement of 0.51 ± 0.26, with the greatest difference in attending cosmetic plastic surgeons (1.36 ± 0.22; p < 0.05). The nose was the most common first fixation location (31 percent of first fixations) and the most viewed area (16 ± 3 percent of fixation time) for all subjects. Experienced subjects spent less time in nonrelevant areas (30 ± 11 percent for attending cosmetic plastic surgeons and 37 ± 10 percent for attending noncosmetic plastic surgeons) compared with less experienced subjects (50 ± 15 percent for laypersons). CONCLUSIONS: This study demonstrates that viewers with greater experience in cosmetic surgery focus quickly on the cheeks, chin, and neck and have evenly distributed gaze across the entire face. These results suggest that a layperson's gaze is drawn to the center of the face (because of both unfamiliarity with the face-lift procedure and the natural tendency to look at the central face), whereas attending plastic surgeons exhibit holistic gaze patterns and are more aware of the impact of the procedure.

Assessing the Fisher, Mohler, and Millard Techniques of Cleft Lip Repair Surgery With Eye-Tracking Technology.

BACKGROUND: Cleft lip repair is essential to restoring physiologic function and ensuring social and psychological well-being in children with orofacial clefts. It is important to critically study various techniques to understand the elements of the lip and nasal repair that contribute to favorable results. Here, we use eye-tracking technology to evaluate how viewers analyze images of cleft lips repaired by the Fisher, Millard, or Mohler techniques. METHODS: Thirty viewers were shown 5 images without deformity and 5 images each of unilateral cleft lips repaired by the Fisher, Millard, or Mohler techniques. Viewers assessed the esthetic quality of images on a Likert scale while eye-tracking technology analyzed their gaze patterns. RESULTS: Of the 3 repair techniques, viewers found Fisher repairs most esthetically pleasing (mean ± standard error, 6.91 ± 0.13). Mohler repairs were next most attractive at (6.47 ± 0.13), followed by Millard repairs at (5.60 ± 0.14). The proportion of time spent in fixed gaze on the nose and upper lip was greatest for Millard repairs (58.3% ± 0.4%) and least for Fisher repairs (51.9% ± 0.5%). Viewers fixated most frequently on the nose and upper lip in Millard repairs (83.2% ± 0.5%) and least frequently in Fisher repairs (75.3% ± 0.5%). When examining the Millard compared with Fisher and Mohler repairs, viewers spent more time and fixations on the ipsilateral lip, nose, and repair scar than on the contralateral lip. CONCLUSIONS: The esthetics of the Fisher repair appear to be favored as measured by Likert scores and gaze data. Eye-tracking technology may be a useful tool to assess outcomes in plastic surgery.

Where Do We Look? Assessing Gaze Patterns in Breast Reconstructive Surgery with Eye-Tracking Technology.

BACKGROUND: Aesthetics plays a large role in determining a successful outcome in plastic and reconstructive surgery. As such, understanding perceptions of favorable aesthetics is crucial for optimizing patient satisfaction. Eye-tracking technology offers an unbiased way of measuring how viewers evaluate breast reconstructions. METHODS: Twenty-nine raters with varied plastic surgery experience were shown 20 images of breast reconstruction at various stages. Breasts were divided into those with nipples and no reconstruction scars, those with nipples and reconstruction scars, and those with reconstruction scars and no nipples. Raters viewed each image for 8 seconds to evaluate aesthetic outcomes. Eye-tracking equipment and software were used to track raters' gaze and analyze the distribution of attention. RESULTS: In breasts with reconstruction scars and no nipples, viewers spent 53.9 percent of the view time examining scars, whereas viewers' attention was divided evenly in breasts with both reconstruction scars and nipples, spending 27.5 percent and 27.7 percent of view time examining the nipples and reconstruction scars, respectively. When examining complete reconstructions, viewers spent more time scanning the entire image before fixating on scars and spent less time on single-site fixation. CONCLUSIONS: Complete reconstructions, which notably include the final nipple-areola complex, appear to play an important role in restoring normal viewing parameters. In essence, completed breast reconstructions with nipple-areola complexes divert attention from extraneous surgical scars and lead viewers to assess the breasts more holistically. Eye-tracking technology provides a powerful link between objective gaze and viewer attention that may potentially be used to predict subjective aesthetic preferences.

Surgical Site Infections after Open Reduction Internal Fixation for Trauma in Low and Middle Human Development Index Countries: A Systematic Review.

BACKGROUND: Musculoskeletal trauma represents a large source of morbidity in low and middle human development index countries (LMHDICs). Open reduction and internal fixation (ORIF) of traumatic long bone fractures definitively manages these injuries and restores function when conducted safely and effectively. Surgical site infections (SSIs) are a common complication of operative fracture fixation, although the risks of infection are ill-defined in LMHDIC. PATIENTS AND METHODS: This study reviewed systematically all studies describing SSI after ORIF in LMDHICs. Studies were reviewed based on their qualitative characteristics, after which a quantitative synthesis of weighted pooled infection rates based on available patient-level data was performed to estimate published incidence of SSI. RESULTS: Forty-two studies met criteria for qualitative review and 32 studies comprising 3,084 operations were included in the quantitative analysis. Among 3,084 operations, the weighted pooled SSI rate was 6.4 infections per 100 procedures (95% confidence interval [CI] 4.6-8.2 infections per 100 procedures). Higher rates of infection were noted among the sub-group of open fractures (95% CI 13.9-23.0 infections per 100 procedures). Lower extremity injuries and procedures utilizing intra-medullary nails also had slightly higher rates of infection versus upper extremity procedures and other fixation devices. CONCLUSIONS: Reported rates of SSI after ORIF are higher in LMHDICs, and may be driven by high rates of infection in the sub-group of open fractures. This study provides a baseline SSI rate obtained from literature produced from LMHDICs. Infection rates are highly dependent on fracture sub-types.

Surgical Site Infections after Appendectomy Performed in Low and Middle Human Development-Index Countries: A Systematic Review.

BACKGROUND: Acute appendicitis is a common surgical emergency worldwide. Early intervention is associated with better outcomes. In low and middle Human Development-Index Countries (LMHDICs), late presentation and poor access to healthcare facilities can contribute to greater illness severity and higher complication rates, such as post-operative surgical site infections (SSIs). The current rate of SSIs post-appendectomy in low- and middle-index settings has yet to be described. METHODS: We performed a systemic review of the literature describing the incidence and management of SSIs after appendectomy in LMHDICs. We conducted qualitative and quantitative analysis of the data in manuscripts describing patients undergoing appendectomy to establish a baseline SSI rate for this procedure in these settings. RESULTS: Four hundred twenty-three abstracts were initially identified. Of these, 35 studies met the criteria for qualitative and quantitative analysis. The overall weighted, pooled SSI rated were 17.9 infections/100 open appendectomies (95% confidence interval [CI] 10.4-25.3 infections/100 open appendectomies) and 8.8 infections/100 laparoscopic appendectomies (95% CI 4.5-13.2 infections/100 laparoscopic appendectomies). The SSI rates were higher in complicated appendicitis and when pre-operative antibiotic use was not specified. CONCLUSIONS: Observed SSI rates after appendectomy in LMHDICs are dramatically higher than rates in high Human Development-Index Countries. This is particularly true in cases of open appendectomy, which remains the most common surgical approach in LMHDICs. These findings highlight the need for SSI prevention in LMHDICs, including prompt access to medical and surgical care, routine pre-operative antibiotic use, and implementation of bundled care packages and checklists.

Surgical Site Infections after Inguinal Hernia Repairs Performed in Low and Middle Human Development Index Countries: A Systematic Review.

BACKGROUND: Inguinal hernias are a common disorder in low- and middle-human development index countries (LMHDICs). Poor access to surgical care and lack of patient awareness often lead to delayed presentations of incarcerated or strangulated hernias and their associated morbidities. There is a scarcity of data on the baseline incidence of surgical site infections (SSIs) after hernia repair procedures in LMHDICs. METHODS: We performed a systematic review of the literature describing the incidence and management of SSIs after inguinal hernia repair in LMHDICs. We conducted qualitative and quantitative analyses of manuscripts describing patients undergoing hernia repair to establish a baseline SSI rate for this procedure in these settings. RESULTS: Three hundred twenty-three abstracts were identified after applying search criteria, and 31 were suitable for the quantitative analysis. The overall pooled SSI rate was 4.1 infections/100 open hernia repairs (95% confidence interval [CI] 3.0-5.3 infections/100 open repairs), which is consistent with infection rates from high-human development index countries. A separate subgroup analysis of laparoscopic hernia repairs found a weighted pooled SSI rate of 0.4 infections/100 laparoscopic repairs (95% CI 0-2.4 infections/100 laparoscopic repairs). CONCLUSIONS: As surgical access continues to expand in LMHDIC settings, it is imperative to monitor surgical outcomes and ensure that care is provided safely. Establishing a baseline SSI rate for inguinal hernia repairs offers a useful benchmark for future studies and surgical programs in these countries.

Surgical Site Infection after Sternotomy in Low- and Middle-Human Development Index Countries: A Systematic Review.

BACKGROUND: The burden of cardiovascular disease is increasing in low- and middle-human development index (LMHDI) countries, and cardiac operations are an important component of a comprehensive cardiovascular care package. Little is known about the baseline incidence of surgical site infections (SSIs) among patients undergoing sternotomy in LMHDI countries. METHODS: A prospectively registered, systematic literature review of articles in the PubMed, Ovid, and Web of Science databases describing the epidemiology and management of SSIs among persons undergoing sternotomy in LMHDI countries was performed. We performed a quantitative synthesis of patients undergoing sternotomy for CABG to estimate published sternotomy SSI rates. RESULTS: Of the 423 abstracts identified after applying search criteria, 14 studies were reviewed in detail. The pooled SSI rate after sternotomy among reviewed studies was 4.3 infections per 100 sternotomies (95% confidence interval [CI] 1.3-6.0 infections per 100 sternotomies), which is comparable to infection rates in high-human development index countries. CONCLUSIONS: As the burden of cardiovascular disease in LMHDI settings increases, the ability to provide safe cardiac surgical care is paramount. Describing the baseline SSI rate after sternotomy in LMHDI countries is an important first step in creating baseline expectations for SSI rates in cardiac surgical programs in these settings.

Surgical Site Infections after Tissue Flaps Performed in Low- and Middle-Human Development Index Countries: A Systematic Review.

BACKGROUND: Surgical site infections (SSIs) affect the safety of surgical care and are particularly problematic and prevalent in low and middle Human Development Index Countries (LMHDICs). METHODS: We performed a systematic review of the existing literature on SSIs after tissue flap procedures in LMHDICs through the PubMed, Ovid, and Web of Science databases. Of the 405 abstracts identified, 79 were selected for full text review, and 30 studies met inclusion criteria for analysis. RESULTS: In the pooled analysis, the SSI rate was 5.8 infections per 100 flap procedures (95% confidence interval [CI] 2%-10%, range: 0-40%). The most common indication for tissue flap was pilonidal sinus repair, which had a pooled SSI rate of 5.6 infections per 100 flap procedures (95% CI 2%-10%, range: 0-15%). No fatalities from an infection were noted. The reporting of infection epidemiology, prevention, and treatment was poor, with few studies reporting antibiotic agent use (37%), responsible pathogens (13%), infection comorbidities (13%), or time to infection (7%); none reported cost. CONCLUSIONS: Our review highlights the need for more work to develop standardized hospital-based reporting for surgical outcomes and complications, as well as future studies by large, multi-national groups to establish baseline incidence rates for SSIs and best practice guidelines to monitor SSI rates.

Clostridium difficile infection in low- and middle-human development index countries: a systematic review.

OBJECTIVE: To describe the impact and epidemiology of Clostridium difficile infection (CDI) in low- and middle-human development index (LMHDI) countries. METHOD: Prospectively registered, systematic literature review of existing literature in the PubMed, Ovid and Web of Science databases describing the epidemiology and management of C. difficile in LMHDI countries. Risk factors were compared between studies when available. RESULTS: Of the 218 abstracts identified after applying search criteria, 25 studies were reviewed in detail. The weighted pooled infection rate among symptomatic non-immunosuppressed inpatients was 15.8% (95% CI 12.1-19.5%) and was 10.1% (95% CI 3.0-17.2%) among symptomatic outpatients. Subgroup analysis of immunosuppressed patient populations revealed pooled infection rates similar to non-immunosuppressed patient populations. Risk factor analysis was infrequently performed. CONCLUSIONS: While the percentages of patients with CDI in LMHDI countries among the reviewed studies are lower than expected, there remains a paucity of epidemiologic data evaluating burden of C. difficile infection in these settings.

Accuracy of remote burn scar evaluation via live video-conferencing technology.

OBJECTIVE: Telemedicine in outpatient burn care, particularly in burn scar management, may provide cost-effective care and comes highly rated by patients. However, an effective scar scale using both video and photographic elements has not been validated. The purpose of this study is to test the reliability of the Patient and Observer Scar Assessment Scale (POSAS) using live video-conferencing. METHODS: A prospective study was conducted with individuals with healed burn scars in Kathmandu, Nepal. Three independent observers assessed 85 burn scars from 17 subjects, using the Observer portion to evaluate vascularity, pigmentation, thickness, relief, pliability, surface area, and overall opinion. The on-site observer was physically present with the subjects and used a live videoconferencing application to show the scars to two remote observers in the United States. Subjects used the Patient portion to evaluate the scar that they believed appeared the worst appearance and had the greatest impact on function. RESULTS: The single-rater reliability of the Observer scale was acceptable (ICC>0.70) in overall opinion, thickness, pliability, and surface area. The average-rater reliability for three observers was acceptable (ICC>0.70) for all parameters except for vascularity. When comparing Patients' and Observers' overall opinion scores, patients consistently reported worse opinion. CONCLUSIONS: Evaluation of burn scars using the Patient and Observer Scar Assessment Scale can be accurately performed via live videoconferencing and presents an opportunity to expand access to burn care to rural communities, particularly in low- and middle-income countries, where patients face significant access barriers to appropriate follow-up care.