A prospective clinical trial evaluating changes in the wound microenvironment in patients with chronic venous leg ulcers treated with a hypothermically stored amniotic membrane.

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 with venous leg ulcers were treated with HSAM from male donors and standard of care for 12 weeks. Over the course of the study, wound exudate was collected and evaluated using proteomic microarrays. Biopsies were collected during the course of treatment to detect the presence of HSAM tissue. By 4 weeks, 60% of subjects achieved 50% or greater reduction in wound size, and by 12 weeks, 53% of subjects achieved 100% re-epithelialization. HSAM DNA was detected in 20% of biopsies as determined by the detection TSPY4, indicating HSAM was no longer present within the wound bed approximately 7 days from the last treatment for the majority of wounds. Proteomic analysis of wound exudate found that wounds on a healing trajectory had significantly higher levels of MMP-10, MMP-7, and TIMP-4 and significantly lower levels of CX3CL1, FLT-3 L, IL-1ra, IL-1a, IL-9, IL-2, IL-3, MCP-1, and TNF-b compared with other wounds.

Development of a Nutrition Screening Tool for an Outpatient Wound Center.

OBJECTIVE: To construct a quickly and easily administered nutrition screening tool using variables believed to be predictive of malnutrition risk in the wound patient population. DESIGN: A prospective pilot study assessed patients on a list of suspected variables, as well as the Scored Patient-Generated Subjective Global Assessment (PG-SGA), chosen as the criterion standard. Variables were analyzed to select the most appropriate items for inclusion on a new nutrition screening tool using preliminary bivariate correlations and χ tests of association. Items significantly associated with malnutrition were dichotomized, and binary logistic regression analyses were performed to arrive at a final model. A sum score was computed, and receiver operating characteristic analysis was used to determine designation of risk. SETTING: An outpatient wound center in Northeast Ohio. PARTICIPANTS: The pilot study included a convenience sample of 105 outpatients with at least 1 active wound. MAIN OUTCOME MEASURES: Malnutrition as assessed by the Scored PG-SGA. MAIN RESULTS: The final nutrition screening tool, the MEAL Scale, is composed of 4 dichotomous elements: multiple wounds (number of wounds), eats less than 3 meals per day, appetite decrease (eats less than usual), and level of activity. These variables predicted 83.7% of the malnutrition cases assessed by the Scored PG-SGA. The receiver operating characteristic analysis showed an acceptable area under the curve (0.8581), and a cutoff score of 2 or greater was selected to indicate risk (median sensitivity = 91.4%, median specificity = 60.9%). CONCLUSIONS: Although further studies of validity and reliability are necessary to establish the tool before widespread use, the MEAL Scale is a needed step toward nutrition screening in a wound patient population.

Analysis of the Pressure Distribution Qualities of a Silicone Border Foam Dressing.

PURPOSE: To determine whether application of a silicone foam dressing is associated with decreased interface pressures when applied to the heel. DESIGN: Prospective, within-subjects design. SUBJECTS AND SETTING: The study was conducted in a community-based hospital using a convenience sample of 50 healthy volunteers with a mean age of 39.6 years and mean body mass index of 26.6; 70% were female. METHODS: Application of the silicone border foam dressing was randomized between the left and right heels. Participants were asked to lie down in the supine position on a viscoelastic foam mattress. Interface pressure measurements were captured using a pressure mapping system; measurements were taken once with the dressing applied to the heel (intervention map) and once without (control map). Data were captured after a 4-minute time period allowing stabilization. Analysis was based on mean interface pressure; data points were collected for both heels in each of the 2 frames, yielding 4 observations per subject. RESULTS: Application of the dressing was associated with a significant decrease in average pressure measurements as compared to the heel with no dressing applied (P < .001). Application of the dressing did not impact pressure readings for the heel to which no dressing was applied (P = .53), and application of the dressing to either the left or right heel did not impact pressure readings (ie, the random effect was insignificant; P = .9). CONCLUSIONS: Application of a silicone border foam dressing is associated with significant reduction in interface pressure and may be considered as part of a pressure ulcer prevention program.

Chitosan-based multifunctional oxygenating antibiotic hydrogel dressings for managing chronic infection in diabetic wounds.

Current treatment strategies for infection of chronic wounds often result in compromised healing and necrosis due to antibiotic toxicity, and underlying biomarkers affected by treatments are not fully known. Here, a multifunctional dressing was developed leveraging the unique wound-healing properties of chitosan, a natural polysaccharide known for its numerous benefits in wound care. The dressing consists of an oxygenating perfluorocarbon functionalized methacrylic chitosan (MACF) hydrogel incorporated with antibacterial polyhexamethylene biguanide (PHMB). A non-healing diabetic infected wound model with emerging metabolomics tools was used to explore the anti-infective and wound healing properties of the resultant multifunctional dressing. Direct bacterial bioburden assessment demonstrated superior antibacterial properties of hydrogels over a commercial dressing. However, wound tissue quality analyses confirmed that sustained PHMB for 21 days resulted in tissue necrosis and disturbed healing. Therefore, a follow-up comparative study investigated the best treatment course for antiseptic application ranging from 7 to 21 days, followed by the oxygenating chitosan-based MACF treatment for the remainder of the 21 days. Bacterial counts, tissue assessments, and lipidomics studies showed that 14 days of application of MACF-PHMB dressings followed by 7 days of MACF dressings provides a promising treatment for managing infected non-healing diabetic skin ulcers.

Nutritional considerations for a new era: A CF foundation position paper.

OBJECTIVE: To provide interim advice and considerations to the CF Community around CF nutrition in the current era. METHODS: The Cystic Fibrosis (CF) Foundation organized a multidisciplinary committee to develop a Nutrition Position Paper based on the rapidly changing nutrition landscape in CF, due in part to widespread use of cystic fibrosis transmembrane regulator highly effective modulator therapy (HEMT). Four workgroups were formed: Weight Management, Eating Behavior/Food Insecurity, Salt Homeostasis and Pancreatic Enzyme use. Each workgroup conducted their own focused review of the literature. RESULTS: The committee summarized current understanding of issues pertaining to the four workgroup topics and provided 6 key take-aways around CF Nutrition in the new era. CONCLUSION: People with CF (pwCF) are living longer, particularly with the advent of HEMT. The traditional high fat, high calorie CF diet may have negative nutritional and cardiovascular consequences as pwCF age. Individuals with CF may have poor diet quality, food insecurity, distorted body image, and an higher incidence of eating disorders. An increase in overweight and obesity may lead to new considerations for nutritional management, given potential effects of overnutrition on pulmonary and cardiometabolic parameters.

Wound dressing absorption: a comparative study.

The purpose of this study was to compare absorption properties of a variety of wound dressing products that are available on the market. A simple, inexpensive method of evaluation was utilized so that new dressings could easily be tested and added to the data set.

Fluorinated methacrylamide chitosan hydrogels enhance collagen synthesis in wound healing through increased oxygen availability.

UNLABELLED: In this study, methacrylamide chitosan modified with perfluorocarbon chains (MACF) is used as the base material to construct hydrogel dressings for treating dermal wounds. MACF hydrogels saturated with oxygen (+O2) are examined for their ability to deliver and sustain oxygen, degrade in a biological environment, and promote wound healing in an animal model. The emerging technique of metabolomics is used to understand how MACF+O2 hydrogel dressings improve wound healing. Results indicate that MACF treatment facilitates oxygen transport rate that is two orders of magnitude greater than base MAC hydrogels. MACF hydrogel dressings are next tested in an in vivo splinted rat excisional wound healing model. Histological analysis reveals that MACF+O2 dressings improve re-epithelialization (p<0.0001) and synthesis of collagen over controls (p<0.01). Analysis of endogenous metabolites in the wounds using global metabolomics demonstrates that MACF+O2 dressings promotes a regenerative metabolic process directed toward hydroxyproline and collagen synthesis, with confirmation of metabolite levels within this pathway. The results of this study confirm that increased oxygen delivery through the application of MACF+O2 hydrogels enhances wound healing and metabolomics analyses provides a powerful tool to assess wound healing physiology. STATEMENT OF SIGNIFICANCE: This work presents the first application of a novel class of oxygen delivering biomaterials (methacrylamide chitosan modified with perfluorocarbon chains (MACF)) as a hydrogel wound dressing. This manuscript also contains strong focus on the biochemical benefits of MACF dressings on underlying mechanisms vital to successful wound healing. In this vein, this manuscript presents the application of applied metabolomics (tandem mass spectroscopy) to uncover biomaterial interactions with wound healing mechanisms. We believe the approaches described in this manuscript will be of great interest to biomedical scientists and particularly to researchers studying wound healing, metabolomics, applied biomaterials and regenerative medicine.

Integrating Structured Learning and Scholarly Activities into Clerkship Rotations: A Win-Win for Students and Preceptors.

Objective: To merge scholarly activity into the curriculum developed for medical students electing a rotation in wound care and/or dermatology. Approach: The authors adapted the unique wound care curriculum developed for medical student rotators and residents to incorporate structured scholarly projects, opportunities for mentorship, and feedback for continued improvement. Results: Benefits have been observed to both students and to the clinic, as reflected by online survey results, increased productivity in the form of posters and manuscripts, and opportunities for professional networking. Discussion: Rotations and clerkships can be transformed from haphazard, bystander observational experiences to active participation that enhances comprehension and retention, while also providing benefits to preceptors. Innovation: Integration between research, education, and clinical activities in a structured way can provide opportunity for enhanced learning experiences and promote the concept of evidence-based practice. Conclusion: With observed benefits to students, researchers, and staff in this clinical setting, other clerkship rotation settings should consider an integrated and structured approach to learning, which includes scholarly activities. Further rigorous program evaluation is necessary to further quantify preliminary positive feedback regarding this approach.

A prospective assessment of sacral pressures in healthy volunteers seated upright and reclined with legs elevated in a recliner.

Prolonged, unrelieved pressure is a major risk factor for pressure ulceration, and interface tissue pressures have been shown to be very high when a person is sitting. Using convenience sampling methods, 23 healthy participants (four men, 19 women, mean age 45 years, body mass index [BMI] range 20-45) participated in a prospective pilot study to evaluate the effect of BMI and two commonly used seating positions in standard hospital reclining chairs on tissue (especially sacral) interface pressures. Measurements were obtained when volunteers were seated upright with plantar surfaces of feet touching the floor (Position 1) and reclining with legs resting on an elevated surface (Position 2). Measurements were obtained for 6 minutes using a thin, flexible force sensing array 430-mm x 430-mm seat mat. Average pressure, maximum pressure, and the number of sensors reading >60 mm Hg and >80 mm Hg were used for analysis across the total surface and at the sacrum. Participants were categorized by BMI (category 1: 20-22, category 2: 23-28, category 3: 29+; no participants had a BMI <20). Leg elevation reduced average pressure across the total surface (from 42.9 mm Hg to 40.0 mm Hg, P = 0.015) and the number of sensors reading >60 mm Hg at the sacrum (from 31.4 to 27.1, P = 0.047). BMI and position were significantly correlated with the number of sensors reading >80 mm Hg (P = 0.008) and average pressure (P = 0.031). Pairwise comparisons showed significant differences existed between BMI categories 1 (average delta: -3.63, indicating down position is better) and 3 (average delta: 4.67, indicating up position is better) for the difference in number of sensors above 80 mm Hg (P = 0.030). Research is needed to further explore the relationship between BMI and tissue pressure, but the results of this study suggest that for patients with a BMI >29, elevating the heels/reclining the chair significantly reduces sacral tissue interface pressure. Further research specific to pressure relief in the sitting position is needed, as neither position examined in this study was found to reduce interface pressures to generally considered safe levels for reduced-mobility patients.

Collect Data, Tell Stories: Utilizing Available Data to Improve Wound Product Selection, Reduce Costs, and Improve Outcomes.

Objective: To develop a tool to assist in the evaluation of treatment options based on clinically relevant parameters, thus enabling clinicians to heal patients more efficiently. Approach: Outlined here is the prototypic model of a comprehensive analysis tool to compare products by category, accounting for product characteristics, effectiveness data from literature, costs, and patient needs or clinician preferences. Results: The tool is demonstrated with a venous leg ulcer example, and ideas for expanding the tool in the future are provided. Innovation: Although this is a simple model, the authors believe that it provides a valid and useful platform for comparing similar products of a given type using available information and reflecting real-world use to give a practical approach to clinical decision-making. Conclusion: Future funding for comprehensive, comparative effectiveness studies should provide clarity on which products to choose for specific applications. Meanwhile, tools like this can provide guidance, and can be modified to accommodate varying circumstances.

A prospective, in vivo evaluation of two pressure-redistribution surfaces in healthy volunteers using pressure mapping as a quality control instrument .

Deep tissue injury (DTI) can rapidly evolve into a higher stage pressure ulcer. Use of pressure-redistribution surfaces is a widely accepted practice for the prevention of pressure ulcers in acute care patients, particularly in departments where care processes limit mobility. A 15-year-old patient developed a sacral DTI 24 hours after completion of a lengthy (12- hour) electrophysiology (EP) study and catheter ablation. A root cause analysis (RCA) conducted to investigate the origin of the hospital-acquired suspected DTI prompted a small investigation to evaluate the pressure-distribution properties of the EP lab surface and an OR table pad. Five healthy adult employee volunteers were evaluated in the supine position by placing a sensing mat between the volunteer and the test surface. Interface pressures (on a scale of 0 mm Hg to 100 mm Hg) were captured after a "settling in" time of 4 minutes, and the number of sensors registering very high pressures (above 90 mm Hg) across the surface were recorded. On the OR table pad, zero to six sensors registered >90 mm Hg compared to two to 20 sensors on the EP lab surface. These data, combined with the acquired DTI, initiated a change in EP lab surfaces. Although interface pressure measurements only provide information about one potential support surface characteristic, it can be helpful during an RCA. Studies to compare the effect of support surfaces in all hospital units on patient outcomes are needed.