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AnteayerInternational Wound Journal

A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

Wound Care Knowledge of Community Pharmacists and Pharmacy Staff: A Cross‐Sectional Survey

ABSTRACT

Chronic wounds pose a public health challenge, with community pharmacists increasingly recognised for their potential role in wound care. Since all chronic wounds originate from acute wounds, pharmacists can play a proactive role in preventing chronicity. Assessing pharmacy staff's wound care knowledge is essential as initiatives to enhance their involvement are underway in Australia. This study aimed to assess wound care knowledge among pharmacists and non-pharmacist staff in Australian community pharmacies. A national cross-sectional electronic survey was conducted between January and August 2022. Developed with multidisciplinary experts, it assessed understanding of wound healing, referral protocols, wound identification, management, and dressing selection. Descriptive and content analyses were performed, and multivariate linear regression identified predictors of knowledge scores. Of 120 responses, 70% were pharmacists, 14% non-pharmacist staff, and 16% unspecified. The median knowledge score was 27 out of 37 (IQR = 21, 30; range = 5–37). Profession, experience, and prior training were significant predictors of higher scores (p < 0.001, R 2 = 0.347). Dressing knowledge was weakest, with only 10 out of 103 respondents (9.7%) correctly identifying all types and applications. Critical knowledge gaps underscore the need for targeted educational interventions for pharmacy staff.

Creating Colostomies for Sacral Pressure Ulcers: A Single‐Centre Retrospective Study

ABSTRACT

Faecal contamination of sacral pressure ulcers occurs frequently, so, theoretically, faecal diversion using colostomies is a useful procedure. We retrospectively analysed the data of adult patients for whom colostomies were created to enhance wound healing and compared patients with sacral pressure ulcers who received colostomies and those who did not during the same period. Patients' characteristics analysed included age, gender, comorbidities, WBC count, serum CRP level and microbial profile (before creating colostomy). Additionally, we examined whether the wound was closed, the recurrence rate after wound closure, and mortality outcomes. Regression analysis indicated that colostomy creation was associated with fewer species of gut microbiota cultured and lower rates of wound dehiscence after closure; no association was found between colostomy and mortality. Colostomies help promote wound healing of sacral pressure ulcers after closure by eradicating wound infection, and do not increase patients' mortality rates.

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real‐World Evidence Study

ABSTRACT

Venous leg ulcers (VLUs) are traditionally managed with standard-of-care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real-world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (n = 312) or collagen/oxidised regenerated cellulose (ORC) (n = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM-treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (p = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM-treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real-world patient cohort.

Incidence and Characteristics of Medical Adhesive‐Related Skin Injuries in Patients Following Spinal Surgery: A Prospective Observational Study

ABSTRACT

This single-center prospective observational study aimed to compare the incidence, types, and characteristics of medical adhesive-related skin injuries (MARSI) in spinal surgery patients based on the type of dressing used. All adult patients who were scheduled for spinal surgery within a one-year period in a single institution were included. A structured case report form was created to collect data; a single assessor evaluated MARSI for eligible patients. Group differences were analysed with an independent t-test or Mann–Whitney U test, and survival analysis was conducted using Kaplan–Meier analysis, the log-rank test, and Cox proportional hazard regression analysis. Within 10 days of surgery, 45% of 140 study participants developed MARSI, with contact dermatitis being the most common type (41.4%). The acrylate-dressing group had a higher cumulative incidence (56.8%) than the silicone group (31.8%) (p = 0.003) as well as a shorter time to the first MARSI (p < 0.001), longer MARSI duration (p < 0.001), and a 2.55-time higher risk of MARSI (p < 0.001). In summary, the use of post-operative dressings with silicone adhesives post-spinal surgery was associated with a lower incidence, longer time to the occurrence, shorter duration, and lower risk of MARSI compared to the use of acrylate dressings.

Effectiveness of quality and quantity mononuclear cells for enhancing wound healing in diabetic ischemic limb animal model

Abstract

This study set forth to investigate the efficacy of Quality and Quantity mononuclear cells (QQMNCs) for promoting wound healing and limb salvage in a severe ischemic wound model using diabetic mice. Female BALB/c nude mice induced with diabetes were used to create ischemic limb models in a controlled experimental design. Intramuscular injections of human QQMNCs were compared to phosphate-buffered saline (PBS) and peripheral blood mononuclear cells (PBMNCs) relative to their effects on wound healing and limb salvage. In vitro analysis demonstrated that the QQMNC group had significantly higher median percentages of CD34+ cells, CD34+CD133+ cells, CD206+ cells, and FOXP3+ cells compared to the PBMNC group (all p < 0.05), which suggests an enhanced regenerative and immunomodulatory profile. Kaplan–Meier survival analysis showed a significantly higher number of completely healed wounds in the QQMNC group than in the PBMNC group (p = 0.044). The histological evaluation showed that the QQMNC group had a significantly thinner epithelial thickness than the PBMNC (p = 0.032) and PBS groups (p = 0.002), and a significantly greater T cell density than the PBS group (p = 0.033), which suggests more efficient tissue repair. Moreover, the QQMNC group exhibited the highest percentage of minor tissue loss (57% for forefoot and toe gangrene), and the lowest incidence of severe limb loss (0% for lower leg gangrene). The findings of this study highlight the effectiveness of QQMNCs for promoting wound healing and limb salvage in diabetic ischemic animal model; however, clinical trials are needed to further assess their efficacy in this clinical context.

The efficacy of topical oxygen therapy for wound healing: A meta‐analysis of randomized controlled trials and observational studies

Abstract

In preclinical studies, topical oxygen treatment (TOT) was shown to enhance wound healing by applying supplemental oxygen topically to the surface of a moist wound at normobaric conditions. The objective of this systematic review and meta-analysis is to provide a thorough evaluation of published RCTs and observational studies that compare supplemental TOT with standard wound care. A total of 1077 studies were obtained from a variety of databases, including PubMed, ScienceDirect, Web of Science, ProQuest, Scopus, ClinicalTrials.gov, EU Clinical Trial Registers, and Preprints.org. The Jadad scale was employed to assess the reliability of RCT studies, while the Newcastle-Ottawa Scale (NOS) was employed to assess the quality of observational studies. Seven RCT studies (n = 692) and two controlled observational studies (n = 111) were analysed. The rate of healed wounds was 25.8% in the control group and 43.25% in the adjuvant TOT group, which shows the use of TOT significantly increased the number of healed wounds (RR = 1.77; 95% CI 1.18–2.64; p = 0.005). A significant decrease in the percentage of wound area was found in the TOT group in RCT studies (mean difference = 15.64; 95% CI 5.22–26.06; p = 0.003). In observational studies, the rate of healed wounds was 37.5% in the standard care group and 80.95% in the adjuvant TOT group, which shows a significant increase in the number of healed wounds in the adjuvant TOT group (RR = 2.15; 95% CI 1.46–3.15; p < 0.00001). Topical oxygen therapy is considered a great adjuvant therapy for chronic wound healing, particularly wounds with vascular compromise such as diabetic ulcers and pressure ulcers. Further studies on this topic are still needed as there are a lot of potential uses for this technology in various types of wounds.

YouTube as a source of information for pressure injury: Quality assessment and content analysis

Abstract

We aimed to assess the quality and reliability of pressure injury-related videos uploaded on YouTube, analyse the sources and contents, and examine the correlation between video parameters. We searched YouTube using two keywords, “pressure ulcer” and “pressure sore”, on August 20, 2022. We sorted the videos according to their number of views and included the top 100 videos for each keyword. The quality of videos was assessed using the Global Quality Scale (GQS), while their reliability was evaluated by the modified DISCERN (mDISCERN) tool. In addition, we evaluated the videos in which content was included, analysed the correlations and differences between GQS, mDISCERN, and video parameters. We initially found a total of 100 videos for each keyword and finally included and analysed 77 videos. The mean scores for the mDISCERN and GQS were 2.35 ± 0.98 and 3.09 ± 0.99, respectively. Both GQS and mDISCERN showed statistically significant correlations with each other (rho = 0.54, p < 0.0001*) and with the length of the videos, respectively (rho = 0.36, p = 0.001*), (rho = 0.29, p = 0.01*). Of the videos created by physicians, 8 (57.1%) included content related to treatment, while of the videos created by nonphysician health personnel, 22 (57.9%) included content related to prevention. Analysing whether there were differences in video parameters based on the sources, we observed significant differences between sources in GQS (p < 0.0001*), mDISCERN (p < 0.0001*), and video length (p = 0.001*). In the post-hoc analysis, videos uploaded by physicians or nonphysician health personnel showed higher quality and reliability than videos uploaded by other sources. Therefore, the results of this study could be useful for healthcare providers, as well as patients and caregivers, to search for high-quality and reliable YouTube videos related to pressure injury.

First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers

Abstract

We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4-week treatment period.

A relationship analysis of the effects of COVID‐19 isolation on pressure sores in a tertiary hospital

Abstract

Management of pressure sores can have various environmental effects; moreover, the COVID-19 pandemic notably affected efforts towards effective management of pressure sores. Some cases of COVID-19 infections require long-term hospitalization in the intensive care unit. Moreover, special protective equipment worn by physicians owing to the pandemic complicate wound management. In this study, we compared the pressure ulcer characteristics between isolated patients with and those without COVID-19 and evaluated the effects of isolation on pressure sores. From November 2022 to February 2023, patients who had pressure sores were included and their medical records were reviewed retrospectively. The experimental group included patients with confirmed COVID-19 infections, who received clinical treatment in an isolated unit. Wound characteristics in each group and associated risk factors were analysed. Fifty-four isolated patients with COVID-19 and 58 control patients were included. The Braden Scale score and Korea patient classification system-1 did not vary significantly between the two groups. However, the number of Grade I pressure sores in the COVID-19 isolation group was significantly lower than those in the control group (p < 0.001), while the number of lesions was significantly higher (p = 0.034). The mortality rate in the COVID-19 isolation group was higher than that in the control group (p = 0.008), and more patients were discharged with unhealed wounds (p = 0.004). A higher treatment effect on pressure sores may be expected if the disease is more actively managed. Moreover, the wound care systems for isolated patients with COVID-19 require further attention.

Use of consecutive transcutaneous oxygen measurement when assessing the need for revascularization and association with the outcomes of ischemic diabetic ulcers

Abstract

This study compared the ankle-brachial index (ABI) with transcutaneous oxygen pressure (TcPO2) in assessing peripheral vascular disease (PVD) prevalence in 100 diabetic foot ulcer (DFU) patients. Patients were categorized into vascular or nonvascular reconstruction groups and underwent both ABI and TcPO2 measurements four times over 6 months. Predictive validity for PVD diagnosis was analysed using the area under the receiver-operating characteristic curve (AUC). The study found TcPO2 to be a superior predictor of PVD than ABI. Among the DFU patients, 51 with abnormal TcPO2 values underwent vascular reconstruction. Only TcPO2 values showed significant pretreatment differences between the groups and increased post-reconstruction. These values declined over a 6-month follow-up, whereas ABI values rose. For those with end-stage renal disease (ESRD), TcPO2 values saw a sharp decrease within 3 months. Pre-reconstruction TcPO2 was notably lower in amputation patients versus limb salvage surgery patients. In conclusion, TcPO2 is more effective than ABI for evaluating ischemic limb perfusion and revascularization necessity. It should be prioritized as the primary follow-up tool, especially for ESRD patients.

Are current wound classifications valid for predicting prognosis in people treated for limb‐threatening diabetic foot ulcers?

Abstract

This study aims to investigate whether the current wound classifications were valid for the treatment prognosis of subjects treated for limb-threatening diabetic foot ulcers (LTDFU). A total of 1548 patients with LTDFU and infection were studied, with wounds recorded using the Wagner, Texas, PEDIS and WIfI classifications while major lower extremity amputations (LEAs) or in-hospital mortality incidences were defined as poor outcomes. Among them, 153 (9.9%) patients received major LEAs and 38 (2.5%) patients died. After adjustments, the Wagner classification and Texas stage as well as clinical factors such as comorbidity with major adverse cardiac events (MACE), being under dialysis and having serum levels of C-reactive protein (CRP) and albumin were independent factors for prognosis. For patients without dialysis, Wagner and Texas stage stood out independently for prognosis. For patients on dialysis, only levels of CRP (odds ratio [OR] = 2.2 in Wagner, OR = 2.0 in WIfI, OR = 2.2 in Texas, OR = 2.3 in PEDIS) and albumin (OR = 0.4 in four classifications) were valid predictors. The Wagner system and Texas stage were valid for predicting prognosis in treatment for LTDFUs, suggesting a role of vascular perfusion. MACE history, levels of CRP and albumin level should assist in prediction; more significantly, only levels of CRP and albumin appeared valid for those subjects undergoing dialysis.

A surfactant‐based dressing can reduce the appearance of Pseudomonas aeruginosa pigments and uncover the dermal extracellular matrix in an ex vivo porcine skin wound model

Abstract

From previous studies, we have shown that viable colony forming units of bacteria and bacterial biofilms are reduced after sequential treatment with a surfactant-based dressing. Here, we sought to test the impact on visible bacterial pigments and the ultrastructural impact following the sequential treatment of the same surfactant-based dressing. Mature Pseudomonas aeruginosa biofilms were grown on ex vivo porcine skin explants, and an imaging-based analysis was used to compare the skin with and without a concentrated surfactant. In explants naturally tinted by bacterial chromophores, wiping alone had no effect, while the use of a surfactant-based dressing reduced coloration. Similarly, daily wiping led to increased immunohistochemical staining for P. aeruginosa antigens, but not in the surfactant group. Confocal immunofluorescent imaging revealed limited bacterial penetration and coating of the dermis and loose pieces of sloughing material. Ultrastructural analysis confirmed that the biofilms were masking the extracellular matrix (ECM), but the surfactant could remove them, re-exposing the ECM. The masking of the ECM may provide another non-inflammatory explanation for delayed healing, as the ECM is no longer accessible for wound cell locomotion. The use of a poloxamer-based surfactant appears to be an effective way to remove bacterial chromophores and the biofilm coating the ECM fibres.

Morphological characteristics of facial scars: A retrospective analysis according to scar location, onset, age, and cause

Abstract

The morphology of facial scars shows a wide variation in terms of texture and colour. To date, there are no reliable predictors of aberrant scarring. We conducted a retrospective analysis to identify factors associated with specific scar features and types. Photographs and medical records of 428 patients with facial scars were retrospectively reviewed. Patients with keloids were excluded. The mean age of the patients was 45.43 ± 23.13 years with a male-to-female ratio of 1:1.36. Atrophic scars were the most common (42.8%), followed by flat scars (38.7%) and hypertrophic scars (18.5%). Scars on the forehead were more likely to be atrophic, whereas scars on the chin/jaw and around the mouth were more likely to be hypertrophic. Hypopigmentation was significantly more common in scars located on the forehead. Redness (erythema) was significantly more common in scars located on the chin/jaw. Old scars were less likely to be erythematous, and hypertrophic. Atrophic scars were more common in younger patients. Scars caused by dermatologic conditions, such as acne, were more likely to be atrophic, whereas surgical scars had the lowest risk of being atrophic or hypertrophic. In conclusion, the location, onset, and cause of facial scars were associated with specific features of scars.

The correlation between transcutaneous oxygen pressure (TcPO2) and forward‐looking infrared (FLIR) thermography in the evaluation of lower extremity perfusion according to angiosome

Abstract

The increased peripheral arterial disease (PAD) incidence associated with aging and increased incidence of cardiovascular conditions underscores the significance of assessing lower limb perfusion. This study aims to report on the correlation and utility of two novel non-invasive instruments: transcutaneous oxygen pressure (TcPO2) and forward-looking infrared (FLIR) thermography. A total of 68 patients diagnosed with diabetic foot ulcer and PAD who underwent vascular studies at a single institution between March 2022 and March 2023 were included. Cases with revascularization indications were treated by a cardiologist. Following the procedure, ambient TcPO2 and FLIR thermography were recorded on postoperative days 1, 7, 14, 21 and 28. In impaired limbs, TcPO2 was 12.3 ± 2 mmHg and FLIR thermography was 28.7 ± 0.9°C. TcPO2 (p = 0.002), FLIR thermography (p = 0.015) and ankle–brachial index (p = 0.047) values significantly reduced with greater vascular obstruction severity. Revascularization (n = 39) significantly improved TcPO2 (12.5 ± 1.7 to 19.1 ± 2.2 mmHg, p = 0.011) and FLIR (28.8 ± 1.8 to 32.6 ± 1.6°C; p = 0.018), especially in severe impaired angiosomes. TcPO2 significantly increased immediately post-procedure, then gradually, whereas the FLIR thermography values plateaued from day 1 to 28 post-procedure. In conclusion, FLIR thermography is a viable non-invasive tool for evaluating lower limb perfusion based on angiosomes, comparable with TcPO2.

Revisiting metformin therapy for the mitigation of diabetic foot ulcer in patients with diabetic kidney disease from real‐world evidence

Abstract

Diabetic foot ulcer and diabetic kidney disease are diabetes-related chronic vascular complications that strongly correlate with high morbidity and mortality. Although metformin potentially confers a wound-healing advantage, no well-established clinical evidence supports the benefit of metformin for diabetic foot ulcer. Thus, this study investigated the effect of metformin on diabetic foot ulcer from a large diabetic kidney disease cohort for the first time. This retrospective cohort study enrolled 10 832 patients who visited the nephrology department more than twice at two South Korean tertiary-referral centers between 2001 and 2016. The primary outcome was diabetic foot ulcer events; secondary outcomes included hospitalization, amputation, a composite of amputation or vascular intervention, and Wagner Grade ≥ 3. Multivariate Cox analysis and propensity score matching (PSM) were used to balance baseline intergroup differences between metformin users and non-users. In total, 4748 patients were metformin users, and 6084 patients were metformin non-users. Over a follow-up period of 117.5 ± 66.9 months, the diabetic foot ulcer incidence was 5.2%. After PSM, metformin users showed a lower incidence of diabetic foot ulcer events than metformin non-users (adjusted hazard ratio 0.41; p < 0.001). In a sensitivity analysis of 563 patients with diabetic foot ulcer, metformin usage was associated with lower severity in all four secondary outcomes: hospitalization (adjusted hazard ratio 0.33; p < 0.001); amputation (adjusted hazard ratio 0.44; p = 0.001); composite of amputation or vascular intervention (adjusted hazard ratio 0.47; p < 0.001); and Wagner Grade ≥ 3 (adjusted hazard ratio 0.39; p < 0.001). In conclusion, metformin therapy in patients with diabetic kidney disease can lower diabetic foot ulcer incidence and progression.

Severe necrotizing soft tissue infections—Is wound microbiology a prognostic factor for clinical outcome?

Abstract

Necrotizing soft tissue infections (NSTIs) represent similar pathophysiological features, but the clinical course might range from subacute to a rapidly progressive, fulminant sepsis. Initial wound microbiology is the base for the Guiliano classification. The timeline of microbiological colonization has not been described during the clinical course. The role of the different microbiological pathogens on the outcome and mortality is unclear. One hundred eighty patients were included with septic inflammation response syndrome on admission. Initial wound microbiology and the changes in wound microbiology were analysed during the clinical course and correlated with outcome and risk indicators. Overall mortality was 35%. Higher age, a high Charlson Comorbidity Index or ASA score and truncal infections were highly prognostic for a lethal outcome. Microbiological findings revealed significant differences in the persistence of bacteria during the course of disease. Streptococci were only detectable within the first 5 days, whereas other bacteria persisted over a longer period of time. Initial microbiological findings correlated with better prognosis when no causative agent was identified and for gram-negative rods. Varying survival rates were observed for different Streptococci, Staphylococci, Enterococci and other bacteria. The highest odds ratio for a lethal outcome was observed for Enterococci and fungi. Microbiological colonization changes during the clinical course of NSTIs and some microbiologic pathogens are predictive for worsening the outcome and survival. Streptococcus pyogenes is only detectable in the very early phase of NSTI and after 6 days not anymore detectable. Later Enterococci and fungi showed the highest odds ratios for a lethal outcome. Enterococci bacteria and fungi have yet not been considered of clinical relevance in NSTI or even as indicator for worsening the outcome.

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