Marissa J Carter

Independent Researcher

Purpose: The aim of this study was to develop a risk stratification system that predicts visual outcomes (uncorrected corrected visual acuity at one week and five weeks postoperative) in patients undergoing cataract surgery. Methods: This was a retrospective analysis in a multitier ophthalmology network. Data from all patients who underwent phac...

Background: An aseptically processed dehydrated human amnion and chorion allograft(dHACA) without terminal sterilization has been shown to improve healing rates in chronic wounds. This randomized controlled trial(RCT) evaluated the safety and effectiveness of weekly and biweekly applications of dHACA plus Standard of Care (SOC) compared to SOC alo...

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal...

Umar S, Lullo JJ, Carter MJ, Shitabata PK, Lee DJ. Clin Cosmet Investig Dermatol. 2022;15:1421‒1427. The authors have advised due to an error that occurred inadvertently at the time of figure assembly the incorrect image was selected for Figure 3 on page 1424. The correct Figure 3 is as follows. Figure 3 CVG and widespread AKN plaques and masses:...

Purpose: Both acne keloidalis nuchae (AKN) and cutis verticis gyrata (CVG) are scalp conditions predominantly affecting men. Both are characterized by dermal thickening and fibroblast hyperactivity. AKN typically occurs in the nuchal area, often involving the naturally occurring folds in the occipital region. The aim of this study was to determine...

Introduction: Lichen planopilaris (LPP) is characterized by chronic scarring alopecia that is progressive and typically refractory to therapy. Current drug treatments are suboptimal and not applicable for long-term use because of the high potential for adverse effects, warranting safer and more effective treatment alternatives. Methods: Based on...

Introduction: The difficulty of the follicular unit excision (FUE) hair transplantation procedure is currently attributed to hair curliness and subsurface angulation. Patients possessing the curliest hair shafts are considered the most challenging. Consequently, patients with these features are often denied FUE. However, this practice does not con...

Purpose: To develop a simple but more precise model to calculate potential annual productivity losses due to blindness and moderate and severe vision impairment (MSVI) at the national, regional, and global level. Methods: Productivity loss was defined as the loss of minimum wage/Gross National Income per capita (GNI) incurred by people aged 50-6...

Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers Approach: Following a literature search of eligible studies from 2010 onward, 4 RCTs were included. Studi...

Objective The study aimed to evaluate whether using a point-of-care test for bacterial protease activity (BPA) to target antimicrobial dressing use can improve outcomes for hard-to-heal wounds and reduce cost. Method Wounds asymptomatic for infection and testing positive for BPA were randomly assigned to two weeks' treatment with a silver antimicr...

Amniotic membranes are known to be rich in growth factors, cytokines, and matrix proteins, which can help support wound closure and may improve patient outcomes in foot and ankle surgical interventions. In this Institutional Review Board (IRB) approved clinical study, 21 consecutive patients undergoing lower extremity soft tissue and bone reconstru...

Purpose: Central centrifugal cicatricial alopecia (CCCA) is the most common cause of scarring alopecia in women of African descent. However, current treatments for CCCA, such as immunosuppressants and immunomodulatory pharmaceutical agents, have suboptimal efficacy and undesirable side effects. This case series reports the therapeutic effect of a...

Objective: To perform an updated meta-analysis of cataract surgical coverage (CSC) data in Latin American studies to confirm that gender equity exists in terms of receiving cataract surgery. Materials and methods: A literature search of Rapid Assessment of Avoidable Blindness (RAAB) studies in Latin American published since 2011 was done. Older...

Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated wit...

Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from a pilot study using a novel purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot ulcers (DFUs), we designed a prospective, multi-centre randomised trial comparing outcomes of PRBM at 12 weeks compared...

Purpose: A challenge in follicular unit excision (FUE) is the lack of a single device that can adequately meet the requirements of a range of patient donor variables, such as hair curliness, race, body and head hair locations, and non-shaven short- and long-hair FUE. This study aimed to describe a novel FUE device developed based on skin responsiv...

In the wake of the coronavirus pandemic, the critical limb ischemia (CLI) Global Society aims to develop improved clinical guidance that will inform better care standards to reduce tissue loss and amputations during and following the new SARS-CoV-2 era. This will include developing standards of practice, improve gaps in care, and design improved re...

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single‐blinded, multi‐centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offl...

Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care g...

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard‐of‐care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers...

Amniotic tissues have been long utilised to treat chronic wounds; however, there are few studies evaluating how the wound microenvironment responds to these therapies. The goal of this study was to evaluate the changes in wounds treated with a hypothermically stored amniotic membrane (HSAM). In this prospective single‐arm study, 15 female patients...

Millions worldwide suffer from chronic wounds challenging clinicians and burdening healthcare systems. Bacteria impede wound healing; however, the diagnosis of excessive bacterial burden or infection is elusive. Clinical signs and symptoms of infection are inaccurate and unreliable. This trial evaluated a novel, point‐of‐care, lateral flow diagnost...

In this secondary analysis of a previous systematic review, we assessed randomized controlled trials evaluating treatments of venous leg ulcers in terms of factors that affect risk of bias at the study level and thus uncertainty of outcomes obtained from the interventions. Articles that assessed the wound bed condition in venous leg ulcers and that...

Introduction. Current approved medications for hair loss, such as topical minoxidil and oral finasteride, may have suboptimal efficacy or side effects precluding continued use in some patients. Thus, we report an evaluation of the efficacy, safety, and tolerability of a new topical botanical formulation -GASHEE containing over 12 phytoactive ingred...

Cataract surgery and drug treatment for neovascular age-related macular degeneration (NVAMD) are among the most common evidence-based ophthalmic procedures and yield substantial benefit to patients. For vulnerable populations who are elderly or disabled and minority populations who have struggled to obtain access to appropriate care most of their l...

Chronic wound treatment currently relies heavily on visual assessment by clinicians; however, the clinical signs and symptoms of infection and inflammation are unreliable in chronic wounds. The specialty of wound care has witnessed the advent of advanced interventions, such as cellular and/or tissue based products (CTP). The success of advanced the...

Introduction: Although integument failure commonly is attributed to pressure alone, especially when a wound develops over a bony prominence (pressure injury), all skin failure should not be attributed to pressure injuries. Objective: A systematic review of the literature was conducted to: (1) differentiate the types of integument injury and etio...

The 2006 U.S. Food and Drug Administration Guidance for Industry emphasizes wound closure as the primary outcome for clinical trials in wound healing. Wound care professionals understand that complete wound healing is not always achievable when evaluating new treatments. FDA, Association for the Advancement of Wound Care, and Wound Healing Society...

Aims: The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound we...

Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment wa...

Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging...

Diabetic foot ulcers (DFUs) have significant clinical impact and carry a substantial economic burden. Patients with DFUs that are refractory to standard wound care are at risk for major complications, including infection and amputation and have an increased risk of mortality. This study evaluated the safety and preliminary efficacy of a novel decel...

Introduction: Chronic wounds are characterized by impaired tissue physiology that stalls healing. The prevalence of wound chronicity presents challenges in wound management and health care cost-containment. Objective: This comparative effectiveness study evaluates the value proposition of 2 collagen-containing wound dressings - oxidized regenera...

This retrospective, matched‐cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split‐thickness skin allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in th...

Aseptically processed dehydrated human amnion and chorion allograft (dHACA) (AmnioBand) has shown great promise in the treatment of recalcitrant diabetic foot ulcers (DFUs) when compared with standard wound care but has not yet been compared to any other tissue forms used in treating DFUs. The hypothesis was to conduct a randomized controlled trial...

Objective Analyse the cost-effectiveness and treatment outcomes of debridement (standard of care) plus BlastX, a biofilm-disrupting wound gel (group 1) or a triple-antibiotic, maximum-strength ointment (group 2), comparing a subset of patients who had not healed at four weeks using the ointment crossed-over to the biofilm-disrupting gel (group 3)....

Patients with wounds bear significant clinical, personal, and economic burdens yet complete wound healing is the only United States Food and Drug Administration (FDA) recognized primary clinical trial endpoint. The overall goal of this project is to work with FDA to expand the list of acceptable primary endpoints, recognizing that new and innovativ...

Objective: The aim of the study was to illustrate the differences in the cost-to-heal wounds using two methods: (1) reimbursement-based costing and (2) activity-based costing (ABC). Approach: A small cohort (100 patients with multiple wounds of which 1 was a diabetic foot ulcer [DFU]) was randomly selected from the U.S. Wound Registry to be represe...

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80...

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading...

Objective: This pilot study evaluates safety in terms of the occurrence of adverse events (AEs) as well as the efficacy in terms of complete wound healing rates of a blood clot product when applied to chronic neuropathic diabetic foot ulcers (DFUs). Materials and methods: Participants were chosen from patients with DFUs visiting the wound care c...

The aim of this multi-center, prospective, observer-blinded, parallel group, randomized controlled trial was to assess the safety and efficacy of EDX110, a nitric oxide generating medical device, in the treatment of diabetic foot ulcers in a patient group reflecting "real world" clinical practice compared against optimal standard care. Participants...

Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alg...

Chronic dermal ulcers affect approximately 2.4-4.5 million people in the USA and are associated with loss of function, decreased quality of life and significant economic burden. Debridement is a critical component of wound care involving removal of nonviable tissue from chronic wounds to stimulate the granulation and epithelialization process. Clos...

Significance: We compare real-world data from the U.S. Wound Registry (USWR) with randomized controlled trials and publicly reported wound outcomes and develop criteria for honest reporting of wound outcomes, a requirement of the new Quality Payment Program (QPP). Recent Advances: Because no method has existed by which wounds could be stratified ac...

Purpose: To develop and implement mechanisms to collect, report, and assess the World Health Organization (WHO) core eye health indicators in Chile, Honduras, Mexico, Peru, and Uruguay. Methods: Simple templates for a situational analysis (of data collection and reporting processes), a national data collection strategy, and a national work plan to...

Objective: The aim of this study was to determine the cost of chronic wound care for Medicare beneficiaries in aggregate, by wound type and by setting. Methods: This retrospective analysis of the Medicare 5% Limited Data Set for calendar year 2014 included beneficiaries who experienced episodes of care for one or more of the following: arterial...

Background: Cerebrospinal fluid (CSF) leaks are a well-known complication of posterior fossa neurosurgery. The use of dural repair adjuncts has been associated with fewer CSF leaks and subsequently, lower medical costs. Objectives: To determine if the use of polyethylene glycol hydrogel sealant (DuraSeal dural sealant system [DuraSeal]), resulted i...

Background: In a recently published, prospective randomized controlled trial (RCT) comparing aseptically processed dehydrated human amnion/chorion allograft (dHACA) to standard of care (SOC), 85% wound closure rates were reported in the dHACA arm while only 25% of patients in the SOC arm healed. Objective: The purpose of this retrospective cross...

Publications based on large healthcare databases that contain data pertaining to wound-related outcomes are starting to appear more frequently. However, concern exists in regard to study design adequacy, the methodology used to minimize misclassifications, bias, and confounding, and lack of full reporting. The STROBE guidelines were published to en...

Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the US Food and Drug Administration (F...

The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regul...

Background: Acellular matrices have been successfully used to heal indolent diabetic foot ulcers (DFUs). These tissues include allogenic dermis as well as xenograft dermis, pericardium, and small intestine submucosa. While all of these tissues show promise for healing DFUs, dermal-derived matrices have shown considerable potential. Materials and...

Objective: Compare enzymatic debridement using clostridial collagenase ointment (CCO) with autolytic debridement using medicinal honey in the hospital outpatient setting for treating pressure ulcers (PUs). Approach: Retrospective deidentified electronic health records from 2007–2013 were extracted from the U.S. Wound Registry. Propensity score matc...

Objective: A previous study suggested that the frequency with which patients visit wound care clinics influences the rate of chronic wound healing but high bias was present with regard to wound care centre selection. The objective of this retrospective cohort study was to confirm this finding by using a very large sample size of diabetic foot ulcer...

Objective: The purpose of this study was to determine the cost-effectiveness (from a payer’s perspective) of adding clostridial collagenase ointment (CCO) to selective debridement compared with selective debridement alone (non-CCO) in the treatment of stage IV pressure ulcers among patients identified from the US Wound Registry. Methods: A 3-state...

Background Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs. Methods Patients...

This study analyzed a cross-section of patients with severe chronic wounds and multiple comorbidities at an outpatient wound clinic, with regard to the cost-effectiveness and cost-benefit of negative pressure wound therapy (intervention) versus no negative pressure wound therapy (control) at 1 and 2 years. Medicare reimbursement charges for wound c...

Background: Among advanced therapeutic interventions for wounds, hyperbaric oxygen therapy (HBOT) has the unique ability to ameliorate tissue hypoxia, reduce pathologic inflammation, and mitigate ischemia reperfusion injury. Most of the conditions for which it is utilized have few successful alternative treatments, and the morbidity and mortality...

Category Diabetes Introduction/Purpose One sequitur of prolonged diabetes is the development of diabetic foot ulcers (DFUs), which are often complicated by lower extremity amputation (LEA). The annual incidence of DFUs and LEAs calculated from the Medicare population is approximately 6% and 0.4% respectively. Many acellular dermal matrices have be...

Category Sports Introduction/Purpose Injury with subsequent surgical repair to the Achilles and Posterior-Tibial tendon as well as the lateral ankle are common procedures for the foot and ankle surgeon. Surgical repair provides the best chance for restoration of strength, power, and function of the muscle-tendon-ligament and bone complex. Healing...

Although macrovascular screening of patients with chronic wounds, particularly in the lower extremities, is accepted as part of clinical practice guidelines, microvascular investigation is less commonly used for a variety of reasons. This can be an issue because most patients with macrovascular disease also develop concomitant microvascular dysfunc...

We assessed the clinical effectiveness of clostridial collagenase ointment as an adjunct to selective debridement compared with selective debridement alone for the management of stage IV pressure ulcers in the hospital outpatient department setting. Outcomes data were derived from retrospective de-identified electronic medical records from 2007–201...

Macrophages are mononuclear phagocytes established during embryogenesis and derived from the yolk sac or the fetal liver but also recruited from the blood and bone marrow under proliferative inflammatory conditions (such as tissue repair). Most importantly, they take on distinct phenotypes and functions crucial to healing upon localization in the w...

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DF...

It is widely accepted that elevated protease activity (EPA) in chronic wounds impedes healing. However, little progress has occurred in quantifying the level of protease activity that is detrimental for healing. The aim of this study was to determine the relationship between inflammatory protease activity and wound healing status, and to establish...

Advanced therapies such as bioengineered skin substitutes (BSS) and dehydrated human amnion/chorion membrane (dHACM) have been shown to promote healing of chronic diabetic ulcers. An interim analysis of data from 60 patients enrolled in a prospective, randomised, controlled, parallel group, multi-centre clinical trial showed that dHACM (EpiFix®, Mi...

Background: The late effects of radiation therapy following the treatment of cancer are a well-known consequence. Evidence increasingly supports the use of hyperbaric oxygen (HBO) as an adjunctive treatment in a variety of radiation injuries. Objective: To present the findings of a new registry of radiation injuries that was developed to evaluat...

Purpose: To estimate the annual loss of productivity from blindness and moderate to severe visual impairment (MSVI) using simple models (analogous to how a rapid assessment model relates to a comprehensive model) based on minimum wage (MW) and gross national income (GNI) per capita (US$, 2011). Methods: Cost of blindness (COB) was calculated for...