Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection and targeted debridement

2019 ◽  
Vol 28 (12) ◽  
pp. 824-834 ◽  
Author(s):  
Rose Raizman ◽  
Danielle Dunham ◽  
Liis Lindvere-Teene ◽  
Laura M Jones ◽  
Kim Tapang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fluorescence Imaging ◽  
Wound Care ◽  
Standard Of Care ◽  
Imaging Device ◽  
Wound Assessment ◽  
Coefficients Of Variation ◽  
Heavy Loads ◽  
Evidenced Based ◽  
Wound Bed Preparation

Objective: Diagnostics which provide objective information to facilitate evidence-based treatment decisions could improve the chance of wound healing. Accurate wound measurements, objective bacterial assessment, and the regular, consistent tracking of these parameters are important aspects of wound care. This study aimed to assess the accuracy, clinical incorporation and documentation capabilities of a handheld bacterial fluorescence imaging device (MolecuLight i:X). Method: Benchtop wound models with known dimensions and clinical wound images were repeatedly measured by trained clinicians to quantify accuracy and intra/inter-user coefficients of variation (COV) of the imaging device measurement software. In a clinical trial of 50 wounds, wound dimensions were digitally measured and fluorescence images were acquired to assess for the presence of bacteria at moderate-to-heavy loads. Finally, fluorescence imaging was implemented into the routine assessment of 22 routine diabetic foot ulcers (DFU) to determine appropriate debridement level and location based on bacterial fluorescence signals. Results: Wound measurement accuracy was >95% (COV <3%). In the clinical trial of 50 wounds, 72% of study wounds demonstrated positive bacterial fluorescence signals. Levine sampling of wounds was found to under-report bacterial loads relative to fluorescence-guided curettage samples. Furthermore, fluorescence documentation of bacterial presence and location(s) resulted in more aggressive, fluorescence-targeted debridement in 17/20 DFUs after standard of care debridement failed to eliminate bacterial fluorescence in 100% of DFU debridements. Conclusion: The bacterial fluorescence imaging device can be readily implemented for objective, evidenced-based wound assessment and documentation at the bedside. Bedside localisation of regions with moderate-to-heavy bacterial loads facilitated improved sampling, debridement targeting and improved wound bed preparation.

scholarly journals Efficacy of a bacterial fluorescence imaging device in an outpatient wound care clinic: a pilot study

2019 ◽  
Vol 28 (7) ◽  
pp. 438-443 ◽  
Author(s):  
Ciaran M. Hurley ◽  
Pat McClusky ◽  
Ryan M. Sugrue ◽  
James A. Clover ◽  
Jason E. Kelly
Keyword(s):  
Real Time ◽  
Fluorescence Imaging ◽  
Predictive Value ◽  
Pathogenic Bacteria ◽  
Wound Care ◽  
Bacterial Species ◽  
University Hospital ◽  
Fluorescent Light ◽  
Care Clinic ◽  
Imaging Device

Objective: Subsurface bacterial burden can be missed during standard wound examination protocols. The real-time bacterial fluorescence imaging device, MolecuLight i:X, visualises the presence of potentially harmful levels of bacteria through endogenous autofluorescence, without the need for contrast agents or contact with the patient. The intended use of the imaging device is to assist with the management of patients with wounds by enabling real-time visualisation of potentially harmful bacteria. The aim of this study was to establish the accuracy of the wound imaging device at detecting pathogenic bacteria in wounds. Methods: A single-centre, prospective observational study was conducted in Cork University Hospital in an outpatient plastic surgery wound care clinic. Patients had their wounds photographed under white and autofluorescent light with the imaging device. Auto-fluorescent images were compared with the microbiological swab results. Results: A total of 33 patients and 43 swabs were included, of which 95.3% (n=41) were positive for bacteria growth. Staphylococcus aureus was the most common bacterial species identified. The imaging device had a sensitivity of 100% and specificity of 78% at identifying pathological bacteria presence in wounds on fluorescent light imaging. The positive predictive value (PPV) was 95.4%. The negative predictive value (NPV) was 100%. It demonstrated a sensitivity and specificity of 100% at detecting the presence of Pseudomonas spp. Conclusion: The imaging device used could be a safe, effective, accurate and easy-to-use autofluorescent device to improve the assessment of wounds in the outpatient clinic setting. In conjunction with best clinical practice, the device can be used to guide clinicians use of antibiotics and specialised dressings.

Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study

2020 ◽  
Vol 29 (Sup7) ◽  
pp. S44-S52 ◽  
Author(s):  
Windy Cole ◽  
Stacey Coe
Keyword(s):  
Wound Healing ◽  
Fluorescence Imaging ◽  
Imaging System ◽  
Wound Care ◽  
Point Of Care ◽  
Bacterial Load ◽  
Case Series ◽  
Wound Area ◽  
Wound Debridement ◽  
Wound Bed Preparation

Objective: Optimal wound-bed preparation consists of regular debridement to remove devitalised tissues, reduce bacterial load, and to establish an environment that promotes healing. However, lack of diagnostic information at point-of-care limits effectiveness of debridement. Method: This observational case series investigated use of point-of-care fluorescence imaging to detect bacteria (loads >104CFU/g) and guide wound bed preparation. Lower extremity hard-to-heal wounds were imaged over a 12-week period for bacterial fluorescence and wound area. Results: A total of 11 wounds were included in the study. Bacterial fluorescence was present in 10 wounds and persisted, on average, for 3.7 weeks over the course of the study. The presence of red or cyan fluorescent signatures from bacteria correlated with an average increase in wound area of 6.5% per week, indicating stalled or delayed wound healing. Fluorescence imaging information assisted in determining the location and extent of wound debridement, and the selection of dressings and/or antimicrobials. Elimination of bacterial fluorescence signature with targeted debridement and other treatments correlated with an average reduction in wound area of 27.7% per week (p<0.05), indicative of a healing trajectory. Conclusion: These results demonstrate that use of fluorescence imaging as part of routine wound care enhances assessment and treatment selection, thus facilitating improved wound healing.

scholarly journals Wound bed preparation from a clinical perspective

2012 ◽  
Vol 45 (02) ◽  
pp. 193-202 ◽  
Author(s):  
A. S. Halim ◽  
T. L. Khoo ◽  
A. Z. Mat Saad
Keyword(s):  
Time Management ◽  
Negative Pressure Wound Therapy ◽  
Chronic Wounds ◽  
Wound Care ◽  
Scientific Basis ◽  
Tissue Necrosis ◽  
Wound Assessment ◽  
Moisture Balance ◽  
Wound Bed Preparation ◽  
Dressing Materials

ABSTRACTWound bed preparation has been performed for over two decades, and the concept is well accepted. The ′TIME′ acronym, consisting of tissue debridement, i nfection or inflammation, moisture balance and edge effect, has assisted clinicians systematically in wound assessment and management. While the focus has usually been concentrated around the wound, the evolving concept of wound bed preparation promotes the treatment of the patient as a whole. This article discusses wound bed preparation and its clinical management components along with the principles of advanced wound care management at the present time. Management of tissue necrosis can be tailored according to the wound and local expertise. It ranges from simple to modern techniques like wet to dry dressing, enzymatic, biological and surgical debridement. Restoration of the bacterial balance is also an important element in managing chronic wounds that are critically colonized. Achieving a balance moist wound will hasten healing and correct biochemical imbalance by removing the excessive enzymes and growth factors. This can be achieved will multitude of dressing materials. The negative pressure wound therapy being one of the great breakthroughs. The progress and understanding on scientific basis of the wound bed preparation over the last two decades are discussed further in this article in the clinical perspectives.

Experience of negative pressure wound therapy over sternal wound healing: A retrospective review

WCET Journal ◽  
2019 ◽  
Vol 39 (2) ◽  
pp. 9-18
Author(s):  
Wai Sze Ho ◽  
Wai Kuen Lee ◽  
Ka Kay Chan ◽  
Choi Ching Fong
Keyword(s):  
Wound Healing ◽  
Negative Pressure ◽  
Negative Pressure Wound Therapy ◽  
Assessment Tool ◽  
Wound Care ◽  
Wound Therapy ◽  
Treatment Pathways ◽  
Wound Assessment ◽  
One Year

Objectives The aim of this study was to retrospectively review the effectiveness of negative pressure wound therapy (NPWT) in sternal wound healing with the use of the validated Bates-Jensen Wound Assessment Tool (BWAT), and explore the role of NPWT over sternal wounds and future treatment pathways. Methods Data was gathered from patients' medical records and the institution's database clinical management system. Seventeen subjects, who had undergone cardiothoracic surgeries and subsequently consulted the wound care team in one year were reviewed. Fourteen of them were included in the analysis. Healing improvement of each sternal wound under continuous NPWT and continuous conventional dressings was studied. In total, 23 continuous NPWT and 13 conventional dressing episodes were analysed with the BWAT. Results Among conventional dressing episodes, sternal wound improvement was 2.5–3% over 10 days to 3.5 weeks, whereas 4–5% sternal healing was achieved in 5 days to 2 weeks with sternal wire presence. Better healing at 11% in 1 week by conventional dressing was attained after sternal wire removal. In NPWT episodes, 8–29%, 13–24%, and 15–46% of healing was observed in 2 weeks, 3.5 to 5 weeks and 6 to 7 weeks, respectively. Only 39% wound healing was acquired at the 13th week of NPWT in one subject. With sternal wire present, 6%–29% wound healing progress was achieved by NPWT in 1–4 weeks, and 16–23% wound improvement in 2 to 4.5 weeks by NWPT after further surgical debridement. After sternal wire removal, 6–34% sternal wound healing occurred by continuous NPWT for 1–2 weeks, and maximum healing at 46% after 2.5 weeks of NPWT were observed. Conclusions Better wound healing was achieved in the NPWT group in comparison to conventional dressings alone. However, suboptimal sternal wound healing by NPWT alone was observed. Removal of sternal wire may improve the effectiveness of NPWT. Successful tertiary closure after NPWT among subjects supports the important bridging role of NPWT in sternal wound healing. Factors causing stagnant sternal wound healing by NPWT alone are discussed.

scholarly journals Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Iwein Gyselinck ◽  
◽  
Laurens Liesenborghs ◽  
Ewout Landeloos ◽  
Ann Belmans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Cytokine Signaling ◽  
Nasopharyngeal Swab ◽  
The Novel ◽  
Proof Of Concept ◽  
Open Label ◽  
Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

scholarly journals AEROBIC EXERCISE VOLUME, NOT PRESCRIPTION, INFLUENCES POST-CONCUSSION SYMPTOMS: A RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 9 (7_suppl3) ◽  
pp. 2325967121S0014
Author(s):  
David R. Howell ◽  
Danielle Hunt ◽  
Stacey E. Aaron ◽  
William P. Meehan ◽  
Can Ozan Tan
Keyword(s):  
Clinical Trial ◽  
Aerobic Exercise ◽  
Symptom Severity ◽  
Exercise Prescription ◽  
Standard Of Care ◽  
Care Group ◽  
Initial Symptom ◽  
Initial Visit ◽  
Severity Scores ◽  
Text Figure

Background: Current recommendations for sport-related concussion uniformly emphasize the importance of physical activity. However, specifics of this recommendation remain vague and do not account for an exercise dosage or compliance. Purposes: First, we examined if an 8-week individualized sub-symptom threshold aerobic exercise prescription, initiated within the first two weeks of concussion, alleviates symptom severity or affects the amount of exercise performed during the study. Second, we examined whether prescription adherence, rather than randomized group assignment, reflects the actual impact of aerobic exercise in post-concussion recovery. Methods: For this single-site prospective randomized clinical trial, participants completed an aerobic exercise test within 14 days of injury, and were randomized to an individualized aerobic exercise program or standard-of-care, and returned for assessments 1 month and 2 months after the initial visit (Table 1). The aerobic exercise group was instructed to exercise 5 days/week, 20 minutes/day, at a target heart rate based on an exercise test at the initial visit. Participants reported their symptom exercise volume each week over the 8-week study period, and reported symptoms at each study visit (initial, 1 month, 2 month). Results: Initial symptom severity was not different between randomized groups (Figure 1A), and no significant differences in symptom severity were found at the 4-week (Figure 1B) or 8-week (Figure 1C) assessment. In addition, there was no significant differences between groups for average weekly exercise volume during the first four weeks (Figure 2A) or second four weeks (Figure 2B) of the study. During the first four weeks of the study, 65% (n=11/17) of the exercise intervention participants were compliant with their exercise recommendation (≥100 min/week), compared to 45% (n=9/20) of the standard-of-care group (p=0.33). During the second four weeks of the study, 71% (n=12/17) of the exercise prescription group exercised ≥100 min/week, compared to 55% (n=11/20) of the standard-of-care group (p=0.50). When grouped by exercise volume, the group who exercised ≥100 minutes/week during the first month of the study reported significantly lower symptom severity scores than those who exercised <100 minutes/week (Figure 3B), despite similar initial symptom severity scores (Figure 3A). Conclusion: Participant randomization within 14 days of concussion did not lead to a significant reduction in symptoms, or greater exercise volume. Given that greater exercise volume was associated with lower symptoms after one month of the study, researchers and clinicians should pay particular attention to adherence to aerobic exercise programs for the treatment of concussion. [Table: see text][Figure: see text][Figure: see text][Figure: see text]

Third-Party Reimbursement for Lower-Extremity Wound Care

2002 ◽  
Vol 92 (1) ◽  
pp. 54-58
Author(s):  
Harry Goldsmith ◽  
Matthew G. Garoufalis
Keyword(s):  
Lower Extremity ◽  
Wound Care ◽  
Standard Of Care ◽  
Third Party ◽  
Foot And Ankle ◽  
Lower Extremity Wound ◽  
Third Party Reimbursement

This article describes the treatment of lower-extremity wounds, specifically foot and ankle ulcerations, in the context of reimbursement for treatments rendered. Therefore, such issues as standard of care, documentation, classification of foot wounds, coding, and reimbursement are discussed. (J Am Podiatr Med Assoc 92(1): 54-58, 2002)

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Sign in / Sign up

Export Citation Format

Share Document