Advances in wound care最新文献

Significance: As an essential procedure, wound care comes with acute pain, which is short but high in intensity, causing patients to fear and affecting subsequent treatment. Nitrous oxide (N₂O) is used to relieve pain related to wound care; however, evidence regarding its application is conflicting. Thus, this systematic review and meta-analysis was performed to evaluate the efficacy of N₂O in wound care-related pain. Recent Advances: Randomized controlled trials that investigated the effect of N₂O in adults undergoing wound care were systematically searched from PubMed, Embase, the Cochrane Library, Web of Science, Scopus, and ClinicalTrials.gov up to February 2023. The primary outcome was the pain score. Secondary outcomes included patients' satisfaction and side effects. Critical Issues: Through screening the 265 identified articles, seven and six studies were finally included in the systematic review and meta-analysis, respectively. Pooled analysis suggested that there was no significant difference in reducing wound care-related pain between the N₂O group and the control group (mean difference [MD], -0.02, 95% confidence interval [CI], -1.46, 1.42; p = 0.98, I² = 96%). Subgroup analyses indicated that there was a significant difference in favor of N₂O for burns, not for ulcers, and N₂O was superior to oxygen and similar to topical or intravenous anesthesia. There was no significant difference in patients' satisfaction or the incidence of side effects between groups. Future Directions: This review suggests that N₂O might be effective for pain management in patients undergoing wound care. Caution must be taken when interpreting these results due to the high risk of biased methods in the included studies.

Significance: The study of extracellular vesicles (EVs), especially exosomes, has unlocked new avenues in understanding cellular communication and potential therapeutic applications. Recent Advances: Advancements in EV research have shown significant contributions from the International Society for Extracellular Vesicles (ISEV), in establishing methodological standards. The evolution of the Minimal Information for Studies of Extracellular Vesicles (MISEV) guidelines from 2014 to 2023 reflects enhanced research rigor and reproducibility. The launch of EV-TRACK platform promotes uniformity and reproducibility by providing a centralized repository for data sharing and standardization practices. Furthermore, databases like EVpedia and ExoCarta have facilitated data sharing and collaboration within the scientific community. Concurrently, exosome-based therapies have emerged as a forefront area within regenerative medicine and targeted drug delivery, showcasing the potential of exosomes in promoting tissue regeneration. Critical Issues: Despite advancements, the field grapples with challenges such as vesicular heterogeneity, EV isolation complexity, and standardization. These issues impact research reproducibility and clinical applications. The inconsistency in exosomal preparations in clinical trials poses significant challenges to therapeutic efficacy and safety. Future Directions: The review outlines critical areas for future research, including the need for technological innovation in EV isolation and characterization, the establishment of standardized protocols, and a deeper understanding of exosome biology. The review also highlights the need to reassess guidelines, develop new EV isolation and characterization technologies, and establish standardized protocols to overcome current limitations. Emphasis is placed on interdisciplinary research and collaboration to address the complexities of EV biology, improve clinical trial design, and ultimately realize exosome's therapeutic and diagnostic potential. Continued evaluation and rigorous scientific validation are essential for successful exosome integration.

Objective: Biofilm infections in chronic wounds are common and pose a significant clinical challenge. This challenge was addressed by developing the SoftOx Biofilm Eradicator (SBE) composed of hypochlorous acid (HOCl) and acetic acid with strong broad-spectrum antimicrobial activity. Approach: First-in-human study investigating the safety and tolerability as primary endpoints and wound size effect and antimicrobial efficacy as secondary endpoints of SBE treatment in chronic leg wound patients. The study was divided into two as follows: a randomized, double-blinded, Single Ascending Dose (SAD) phase (n = 16 SBE; n = 4 placebo), where patients were treated with SBE or saline (placebo) only once, followed by an open-label, Multiple Ascending Dose (MAD) phase (n = 8), where patients were treated with SBE once daily or twice daily over five days. Reporting is according to CONSORT guidelines. Results: SBE was safe and well-tolerated in chronic leg wound patients. There were no significant differences in pain during and after treatment with SBE or the placebo. The SBE treatment reduced bioburden in wounds compared to baseline, with 98% and 49% median reduction after SBE or placebo treatment, respectively. A dose-dependent trend in absolute wound size reduction was observed in the MAD groups with a median (min, max) change of -2.99 (-14.25, -1.5) cm² in the once-daily and -10.48 (-17.95, -0.38) cm² in the twice-daily group, respectively. Innovation and Conclusion: This study demonstrated the safe use of HOCl-based SBE in chronic leg wounds with promising trends of immediate antimicrobial action and beneficial effect on wound healing.

Objective: To evaluate the clinical efficacy of combining an offloading device with a contralateral shoe lift to compensate for induced limb-length discrepancies in participants with plantar diabetes-related foot ulcers. Approach: Between March 2021 and December 2023, 42 consecutive patients with active plantar diabetic foot ulcers (DFUs) were randomly assigned (1:1) to the treatment group (limb-length discrepancy compensation with a shoe lift in the therapeutic footwear of the contralateral limb) or a control group that did not receive limb-length discrepancy compensation. Primary outcomes included the 20-week wound-healing rate and wound area reduction. Secondary outcomes included minor amputation, new ulcers in the contralateral limb, perceived comfort, and hip pain. Results: On an intention-to-treat basis, 15 participants in the control and 19 in the treatment group showed ulcer healing (p = 0.0023). In those with >80% adherence to the offloading device, multivariate analysis showed that the shoe lifts improved ulcer healing time. The use of a shoe lift reduced the number of minor amputations and the occurrence of new ulcers in the contralateral limb (p = 0.035; p = 0.033 respectively). Hip pain and perceived comfort improved with the use of shoe lifts (p < 0.001). Innovation: It validates the use of shoe lifts for patients with DFUs, as it is the first largest study of its kind to establish a clear reference standard to guide clinician decision-making. Conclusion: The use of shoe lifts reduced healing time in participants with diabetes and active plantar foot ulcers. Shoe lifts reduce late complications, including new ulcers in the contralateral limb and minor amputations.

Standardized care is crucial in health care for ensuring consistent, safe, high-quality, efficient, and evidence-based practices. Care pathways that standardize procedures promote adherence to best practices, reduce variability in treatment, and encourage collaboration among health care teams. This approach ultimately improves patient outcomes, enhances safety, and boosts the overall effectiveness of health care services. However, despite these benefits being widespread across most of the U.S. health care system, wound care stands out as an area where standards can vary significantly. The inconsistency in wound care standards in the United States can be traced to several factors. These include limited structured clinical wound care education, the discretion of health care providers in different business environments, differences in wound care settings, varying access to advanced treatments and technology, patient demographics and socioeconomic status, as well as differences in state laws and regional or institutional practices. Addressing these disparities requires a comprehensive approach that considers the complex interplay of the abovementioned factors. Active measures are needed to improve access, equity, and the quality of wound care services for all patients, regardless of where they live, their socioeconomic status, their health care coverage, or the business interests of providers and their institutions as well as of vendors marketing wound care products inconsistent with evidence-based practice. By understanding and actively addressing these factors, we can work toward achieving more standardized, evidence-based, and patient-centered practices in wound care across the nation.

Objective: The purposes of this observational prospective study were to (1) characterize the wound-related factors (wound area, the presence of biofilm, and total bacteria), wound-related symptoms (fatigue, pain, exudate, itching, and edema or swelling), and systemic inflammation (level of serum C-reactive protein [CRP]), and (2) explore associations between wound-related factors, wound-related symptoms, and systemic inflammation in older individuals with chronic venous leg ulcers (CVLUs) over 8 weeks of wound treatment. Approach: A total of 117 participants who received standardized care (weekly sharp debridement) for chronic venous ulcer were enrolled. We collected clinical data every 2 weeks during the 8 weeks of the study period or until the wound was healed (if healed before 8 weeks). Associations among variables were estimated using a Bayesian approach applied to general linear mixed models. Results: Based on Bayes factor (BF) value, there was extremely strong evidence for the association of biofilm with mean total bacteria (BF >1,000). There was moderate evidence of a direct association between biofilm presence and levels of CRP (BF 4.3) and moderate evidence of direct associations between biofilm and wound-related symptoms, pain and exudate (BF 5.12, 8.49, respectively). Innovation: Wound-related symptoms and the level of systemic CRP were associated with biofilm among patients who were receiving weekly sharp debridement. Symptom severity associated with CVLUs requires assessment and management of wound-related factors and levels of inflammation in addition to symptom assessment. Conclusion: This study is the first to examine associations among biofilm, as wound-related factors, systemic inflammation, wound-related symptoms, and wound healing in clinical settings. Symptom severity, level of systemic CRP, and wound-related factors should be considered as well as assessment of biofilm in CVLU in older individuals with CVLU.

Objective: Chronic wound healing is a complex process that is still not well understood. The tryptophan (TRP)-l-kynurenine (KYN) pathway has recently been under increased scrutiny with regard to wound healing. The study applied metabolomics to elucidate the TRP-l-KYN pathway associated with wound healing in chronic venous leg ulcers (CVLUs). Approach: This study used a longitudinal comparative design of 60 serum samples collected from 30 older adult patients with CVLUs, receiving weekly sharp debridement at a wound clinic. The serum samples were collected at baseline and week 4 (healed wounds) or week 8 (nonhealed wounds). Liquid chromatography-mass spectrometry (LC-MS) metabolomics was used to analyze targeted metabolites. A Bayesian approach was used to examine robust correlations between changes in metabolite values and linear healing slope and to compare by group. Results: The mean age was 71.13 (±9.46 years). Half of the sample were female and the minority (17%) were Black. The mean values of evaluated metabolites for the nonhealed group were consistently lower than those for the healed group. The healed group (n = 12) had higher KYN values. Those on a healing trajectory (n = 23) had lower KYN levels and higher TRP levels at baseline and over time. There was moderate support (Bayes factor = 3.70) for a negative association between change in kynurenic acid and linear healing slope (r = -0.35, credibility intervals [CrI] = -0.62, -0.04; probability of direction [PD] = 98%). Results suggest that KYN and TRP may be markers for healing in individuals with CVLUs. Innovation and Conclusion: Gaining a better understanding of the associations between the TRP-l-KYN pathway and the healing of CVLUs may help to clarify the links of inflammation with the rate and success of wound healing. Biomarker development focused on the TRP-l-KYN pathway could be pursued, if the associations are further supported by focused research studies.

Objective: Hard-to-heal diabetic foot ulcers (DFUs) are associated with higher mortality rates and an increased medical burden for patients. ON101, a new topical cream, exhibited better healing efficacy than the control dressing in a Phase III trial. In this post hoc analysis, we further identify whether ON101 can improve the healing of ulcers with hard-to-heal risk factors in this cohort of DFU patients. Approach: To compare the efficacy of ON101 with absorbent dressing among various hard-to-heal wounds in patients with DFU, a post hoc analysis of a randomized Phase III trial that included 276 DFU patients was performed by subgrouping those patients based on ulcer depth, location, size, duration, and patients' glycated hemoglobin (HbA1c) levels and body mass index (BMI). Results: In the full analysis set, the proportion of patients achieving healing was 61.7% in the ON101 group and 37.0% in the comparator (p = 0.0001). In subgroup analysis according to risk factors, ON101 demonstrated superior healing capacity on Wagner grade 2 ulcers (p < 0.0001); plantar ulcers (p = 0.0016), ulcer size ≥5 cm² (p = 0.0122), ulcer duration ≥3 months (p = 0.0043); for patients with HbA1c ≥9% (p = 0.0285); and patients with BMI ≥25 (p = 0.0005). Innovation: ON101, a novel therapeutic drug, can modulate the functions of macrophages and demonstrate superior healing rates to conventional absorbent dressing in patients with hard-to-heal DFUs. Conclusions: The results of this post hoc study suggest that ON101 is a better therapeutic option than conventional dressing used in treatment for DFU patients with higher HbA1c, BMI, or ulcers with complex conditions such as longer duration, deeper wounds, larger size, and plantar location.

Objective: To evaluate the efficacy of density-33 (D33) sealed foam in preventing skin injuries from surgical positioning. Approach: The study, reported according to the Consolidated Standards of Reporting Trials, is characterized as a randomized clinical trial, double mask, with 64 adult patients undergoing elective surgery, 35 allocated to the control group (CG), positioned on a conventional surgical table, and 29 to the experimental group (EG), positioned on a conventional surgical table overlaid with a D33 sealed foam support surface (SS) in the occipital, sacral, and heel regions. Simple randomization was carried out, as was masking of the researcher who evaluated the skin of the patient and the statistician. Data collection was carried out immediately preoperatively, intraoperatively, and postoperatively until the third day or until patient discharge. Statistical analysis included measures of association in contingency tables, χ², and relative risk to compare the incidence of injuries between groups. Results: Skin injuries were greater in the CG, with blanchable erythema being the main injury. The use of D33 sealed foam reduced the incidence of injury in the EG by 61.2% (relative risk: 0.39; 95% confidence interval: 0.220-0.684; p < 0.001). Innovation: One of the first clinical studies to demonstrate that using a D33 sealed foam SS decreased the incidence of blanchable erythema from surgical positioning. Conclusion: D33 sealed foam was effective in preventing skin injury from surgical positioning in patients undergoing elective surgeries.