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Early indicators of healing provide valuable information on the potential benefit of treatment. In patients with hard-to-heal (chronic) diabetic foot ulcers (DFUs), timely intervention is critical. Ulcers that fail to show measurable progress within four weeks of treatment are considered recalcitrant. These ulcers increase the risk of soft tissue infection, osteomyelitis and lower extremity amputation. A prognostic indicator or surrogate marker allows for rapid evaluation of treatment efficacy and safety. An inverse correlation between a percentage area reduction (PAR) of ≤50% at week 4 and complete healing by week 12 has been previously established; however, the data were derived from a standard of care (SoC) arm of clinical trials that are over a decade old. In this post hoc analysis, data from a large multicentre prospective randomised controlled trial were reviewed to assess PAR at week 4 as a prognostic indicator in patients treated with SoC. Overall, 65.4% (17/26) of patients with PAR >50% at week 4 achieved complete closure at week 12. The receiver operating characteristic (ROC) curve for area reduction by week 4 showed strong discrimination for predicting non-healing (area under the ROC curve: 0.92; p<0.001; positive predictive value: 70.6%; negative predictive value: 87.2%). These findings are consistent with previous studies and support the use of four-week PAR as a prognostic indicator.

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BACKGROUND: Incontinence-associated dermatitis (IAD) is a tough problem in clinical settings, not only increasing the risk of complications like catheter-related urinary tract infections and pressure ulcers in elderly and critically ill patients, but also prolonging hospital stays, raising hospital costs, and possibly leading to medical disputes. This study is aimed to evaluate the therapeutic effect of silicone dressing combined with topical oxygen therapy on IAD in a rat model. METHODS: An IAD rat model induced by synthetic urine with trypsin was established. Hematoxylin & eosin staining was carried out to examine skin histology. Using immunofluorescence, the microvessel density in the affected skin tissues was determined. ELISA was performed to measure the concentrations of inflammatory cytokines and angiogenic factors in serum. The mRNA expression of EGF, PDGF, and VEGF was detected via qRT-PCR. Western blotting was employed to determine NF-κB p65/STAT1 pathway-related protein levels. RESULTS: Compared to single therapy, silicone dressing combined with topical oxygen therapy could significantly reduce the severity of IAD, improve skin histology, inhibit inflammation, and promote angiogenesis in IAD rat models. Additionally, the results showed that relatively speaking, the combined therapy suppressed the NF-κB p65/STAT1 signaling pathway more effectively. CONCLUSION: These findings indicated that silicone dressing combined with topical oxygen therapy can alleviate IAD through promoting wound healing and inhibiting inflammation via NF-κB p65/STAT1 signaling pathway in a rat model, which provided a theoretical basis for the prevention and treatment of IAD in clinic.

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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.

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Gingivitis and periodontitis are common oral pathological conditions. Several optional adjunctive local therapies are used clinically. While antibiotics and chlorhexidine are the most common agents of choice, their long-term use is associated with several adverse effects. Some of these include staining of teeth and restorations, cellular cytotoxicity and hypersensitivity. Topical oxygen therapy has been recently introduced and could be clinically capable of inhibiting plaque bacterial biofilm growth. Available as a mouthwash, toothpaste and oral gel, this formulation comprises cellulose, glycerol and sodium peroxoborate, and releases topical oxygen in a controlled manner. Moreover, it releases topical oxygen, in a controlled manner, and lactoferrin, which are capable of antibacterial action and stimulation of bone cells, respectively. The aim of this paper is to report a case of gingivitis and another case of periodontitis, both of which were successfully treated clinically with adjunctive local oxygen therapy (blue®m). Additionally, this paper aims to review the relevant literature in terms of adjunct topical or local therapies used in the treatment of gingivitis and periodontitis, in order to understand how local therapies are helpful and to know if local oxygen therapy is a suitable clinical alternative.

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DECLARATION OF INTEREST: TS is a consultant for Inotec AMD Ltd., UK. The authors have no other conflicts of interest to declare.

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The aim of this scoping review was to provide an overview of current research into topical oxygen therapies including the under-researched singlet oxygen for wound healing. A scoping review was undertaken using five databases. After duplicates and ineligible studies were excluded, 49 studies were included for a narrative review. Out of the included 49 studies, 45 (91.8%) were published in the past 10 years (2013-2023) with 32 (65.3%) published in the past 5 years (2018-2023). Eight of the studies were systematic reviews and/or meta-analysis and 18 were RCTs. The search identified zero human RCTs on singlet oxygen, but one human cohort study and five studies in animals. There is evidence that topical oxygen therapy may be useful for the treatment of chronic wounds, mainly diabetic foot ulcers. Singlet oxygen has shown potential, but would need further confirmation in controlled human trials, including more research to understand the bio-properties.

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OBJECTIVE: Patients in rural communities may have limited access to wound care; however, this may be mitigated by using a shared care approach. This study assessed the impact of a remote assessment and monitoring tool in combination with adjunctive continuous topical oxygen therapy (cTOT) in patients with diabetes and hard-to-heal wounds. METHOD: Patients with hard-to-heal wounds (defined as no visible improvement in the previous four weeks) were enrolled to this 12-week pilot study to validate a shared care approach using an Advanced Digital Wound Care Platform-telehealth (ADWCPt) system (eKare Inc., US) coupled with cTOT. Patient and wound assessments were reviewed by the clinician either remotely, via telehealth calls, or at the clinic, and the number of face-to-face clinic visits was recorded. Patient health status scores were captured before and after the study, along with feedback on usability of the remote platform and cTOT device. RESULTS: The wounds in all eight patients studied reduced in size over 12 weeks (mean percentage area reduction 92.0%), and two wounds were completely re-epithelialised. Another wound almost healed (99.2% wound area reduction). Clinical interactions consisted of self-assessments (n=80, 50.0%), video assessments with the clinician (n=27, 16.9%), and face-to-face interactions in clinic (n=53, 33.1%). Operational efficiencies encompassed a 54.0% increase in the number of clinical interactions, whereas clinical time was reduced by 25.8%. Health status scores improved across all eight patients and feedback on the shared approach and cTOT device was favourable. CONCLUSION: A shared care model with ADWCPt coupled with an innovative cTOT device saved time and resources, improving patient access and engagement, along with a marked improvement in the wound healing trajectory.

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The temporary ligation of the common carotid artery is performed as an emergency aid in cases of guttural pouch mycosis. Its usefulness is put into perspective after an anatomical summary of arterial vascularization involving a guttural pouch. It helps to better understand the need for the cranial (cerebral) and caudal (cardiac) occlusion of an arterial rupture by embolization in order to achieve maximum success in preventing and treating an hemorrhage. Topical oxygen therapy used alone or in a multimodal approach with embolization surgery is performed to promote healing of the inflammatory and mycotic lesions observed when an individual is affected. In conclusion, this three-step therapeutic approach should enable the equine practitioner to better orient their decision tree when faced with this condition which, while rare, can be potentially fatal if poorly treated.

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Diabetic foot ulcer (DFU) is one of the most costly and serious complications of diabetes. Treatment of DFU is usually challenging and new approaches are required to improve the therapeutic efficiencies. This review aims to update new and upcoming adjunctive therapies with noninvasive characterization for DFU, focusing on bioactive dressings, bioengineered tissues, mesenchymal stem cell (MSC) based therapy, platelet and cytokine-based therapy, topical oxygen therapy, and some repurposed drugs such as hypoglycemic agents, blood pressure medications, phenytoin, vitamins, and magnesium. Although the mentioned therapies may contribute to the improvement of DFU to a certain extent, most of the evidence come from clinical trials with small sample size and inconsistent selections of DFU patients. Further studies with high design quality and adequate sample sizes are necessitated. In addition, no single approach would completely correct the complex pathogenesis of DFU. Reasonable selection and combination of these techniques should be considered.

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Diabetic foot ulcers (DFUs) are a prevalent complication of diabetes mellitus and are associated with significant morbidity and mortality. The essential role of oxygen in the treatment of DFUs is documented. Indicated for use on a variety of wound types, topical haemoglobin therapy (Granulox®) is a novel therapeutic technology that binds atmospheric oxygen and improves the availability of oxygen at the wound site. When used as part of the wound management strategy, this therapy helps to reduce inflammation, exudate and slough, and promotes wound healing. In South Africa, health resources, coordinated foot care and podiatry, and data on diabetic foot complications are limited. Twelve patient case studies assessing the impact of adding topical haemoglobin therapy to the management regimes for DFUs and surgical (post-amputation) wounds were undertaken in South Africa. Patients were aged 50-71 years, and all had diabetes mellitus. At baseline, the area of the wounds ranged from 10.2 to 149.6 cm2 with depths ranging from 0.2 to 0.9 cm. Clinical signs of wound infection and high levels of viscous exudate were recorded in all cases. Wound dressings were changed twice weekly and sharp debridement of the wound performed as necessary. The wounds were cleansed and then completely coated with a thin film of Granulox® and dressings applied. Treatment was monitored over periods ranging from 57 to 276 days, during which dressings were changed and Granulox® administered to the wounds, ranging from 16 to 79 times. During the period of evaluation, wound size steadily reduced (by 87.1-100%), the condition of the wound bed tissue and peri-wound skin improved, and clinical signs of wound infection steadily resolved. Wounds significantly improved in two patients, almost healed in six patients, and healed in four patients. All patients reported a reduction in malodour and pain; seven patients were pain-free at the final followup assessment. The overall impression of Granulox® was rated as 'very good' by the clinicians, who considered that Granulox® facilitated an increase in tissue viability, with the promotion of granulation tissue, and stimulated epithelialisation.

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Purpose: Diabetic foot ulcer (DFU) is a significant healthcare burden demanding prompt attention. In the past decade, newer technologies such as topical oxygen therapy have grown increasingly popular. The purpose of the study was to determine effect of KADAM-a topical warm oxygen therapy (TWOT) medical device in healing of DFU. Methods: The KADAM medical device developed by Yostra Labs Pvt Ltd, delivered pure oxygen between 93 ± 3% concentration at an optimal temperature range of 39-42º Celsius to DFU wound site. Results: A total of 40 diabetic foot ulcer individuals, aged over 18 years were included in the study. Individuals with the Grade 1 DFU were 34 (85%), grade 2 were 5 (12.5%) and grade 3 were 1 (2.5%). The changes in initial area and final area for the various diabetic foot ulcer grades were as follows: 0.32 [0.12, 0.96] (< 0.001) for grade 1 ulcer, 0.76 [0.54, 1.17] (P = 0.013) for grade 2 ulcer and 1.26 for grade 3 ulcer. The percentage reduction in wound size achieved for the grade 1 & 2 DFU were 100%, and grade 3 was 75%. Conclusion: Topical warm oxygen therapy serves as an adjunctive modality to facilitate diabetic foot ulcer healing in the clinical practice.

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There is wide regional variation in clinical practice and access to treatment for patients with diabetic foot ulcer (DFU) from countries in Central and Eastern Europe (CEE). A treatment algorithm that reflects current treatment practices while providing a common framework may facilitate best practice in DFU management and improve outcomes across the CEE region. Following a series of regional advisory board meetings with experts from Poland, the Czech Republic, Hungary and Croatia, we present consensus recommendations for the management of DFU and outline the key features of a unified algorithm for dissemination and use as a quick tool in clinical practice in CEE. The algorithm should be accessible to specialists as well as non-specialist clinicians and should incorporate: patient screening; checkpoints for assessment and referral; triggers of treatment change; and strategies for infection control, wound bed preparation and offloading. Among adjunctive treatments in DFU, there is a clear role for topical oxygen therapy, which can be used concomitantly with most existing treatment regimens in hard-to-heal wounds following standard of care. Countries from CEE face a number of challenges in the management of DFU. It is hoped that such an algorithm will help standardise the approach to DFU management and overcome some of these challenges. Ultimately, a regionwide treatment algorithm in CEE has the potential to improve clinical outcomes and save limbs.

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OBJECTIVE: To quantify the reduction in wound size and change in wound quality following low-cost topical oxygen therapy (TOT) in patients with acute traumatic musculoskeletal wounds of the foot and ankle. METHOD: This prospective interventional study included patients with acute traumatic musculoskeletal wounds of the foot and ankle of <3 weeks' duration after they had undergone debridement and required subsequent wound coverage. A sterile C-Arm cover was used to cover the wound and 100% oxygen was administered at 1 atm, at a rate of 10l/min for 90 minutes on each of four consecutive days, through a suction catheter connected to an oxygen cylinder. The cycle was repeated after a three-day break. Wound surface area (by plotting on graph paper) and wound quality (by modified wound infection checklist score and swabs for culture and Gram staining) were assessed before and after TOT application. RESULTS: The study cohort included 20 patients ≥18 years of age. There was a statistically significant (p<0.001) reduction in mean wound surface area from 79.3cm2 at baseline to 69.6cm2 after two cycles of TOT. The mean modified wound infection checklist score was 13.6 and 0.8, respectively, before and after two cycles of TOT, suggesting statistically significant improvement (p=0.02) in wound quality. All patients showed no growth in their wound culture after TOT. CONCLUSION: TOT appears to be a promising and cost-effective alternative in the management of traumatic wounds. However, future studies with larger sample sizes and control groups for comparison are needed to establish the benefit of TOT in acute traumatic musculoskeletal wounds.

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INTRODUCTION: Diabetes affects 400 million people globally and patients and causes nephropathy, neuropathy, and vascular disease. Amongst these complications, diabetic foot ulcers remain a substantial problem for patients and clinicians. Aggressive wound care and antibiotics remain important for the healing of these chronic wounds, but even when treated these chronic ulcers can lead to infection and amputations. AREAS COVERED: This paper reviews the pathophysiology of diabetic foot ulcers and the current management strategies. Then, it discusses novel therapeutics such as topical oxygen therapy as well as autologous patches and macrophage creams. EXPERT OPINION: Diabetic foot ulcers are a substantial problem for patients and clinicians. Early identification, aggressive wound care, and normoglycemia remain the standard of care, however when these fail it is important to adapt. Since each patient and wound vary drastically we believe they should be treated as such. For patient with intact perfusion, topical ON101 and sucrose octasulfate creams can help. While patient with peripheral arterial disease should consider topical oxygen therapy as an adjunct. However, as scientists gain a better understanding of the pathophysiology behind DFUs, the hope is that this new wave of therapeutics will emerge.

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Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) 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, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Results: Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07-2.37; p = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Innovation: Our study shows that TOT is a viable diabetic foot ulcer therapy. Conclusions: These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.

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INTRODUCTION: While the use of hyperbaric oxygen therapy has been supported by randomized prospective trials for the use of selective lower extremity wounds, it is associated with significant cost, inconvenience, and a small risk of pneumothorax, barotrauma to the tympanic membrane, and severe hypoglycemia. As topical oxygen therapy (tOT) avoids these issues and there is little literature examining its use for patients with peripheral arterial disease (PAD), we reviewed our experience with tOT as an adjunctive technique for wound healing with arterial wounds. METHODS: We reviewed our experience with tOT for lower extremity wounds over 8 years. PAD patients with non-healing ulcers were referred to tOT after having revascularization of the limb and/or debridement where appropriate. tOT was administered to affected areas 4 times a week with a local boot that delivered 100% oxygen to the wound at 1.03 atm for 90-min sessions. We had 28 patients with PAD, 57.1% male, and 36 individual wounds. Ages ranged from 37 to 93 (mean 62 ± 13.7). 82% had a history DM, 75% hypertension, and 60.7% hyperlipidemia. 78% had lower extremity arterial angioplasty and 11% had a LE bypass. The remainder had a debridement only and were not candidates for arterial revascularization. RESULTS: tOT duration ranged from 1 to 7 months (mean 3 ± 2). 29% stopped tOT before healing. 25% healed completely. One died during follow-up. Overall, 66% had reduction of the wound area ranging from 12% to 100%. None had major limb amputation. 18% underwent toe amputations. 25% of our patients were lost to follow-up. CONCLUSION: While these data are from a single-center and are single-armed, they represent the largest reported series of this therapy. This home-based therapy does show promise and warrants further investigation.

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Objective To systematically analyze and compare studies related to the intervention effect of topical oxygen therapy on patients with diabetic foot ulcers,and provide references for nursing practice.Methods We searched PubMed,Embase,Web of Science,CENTRAL,CINAHL,Clinical Trial,China Biomedical Literature Database,CNKI,Wanfang Database,and VIP from inception to February 1,2023,to collect studies on the effect of topical oxygen therapy interventions on patients with diabetic foot ulcers.2 researchers independently screened the litera-ture,and extracted the information,and a meta-analysis of the included literature was performed by RevMan 5.4 software.Results 8 studies with 622 patients were included.Meta-analysis results showed that compared with con ventional care,topical oxygen therapy improved the response rate[RR=1.59,95％CI(1.16,2.17),P=0.004]and the reduction of diabetic foot ulcer area[MD=28.78,95％CI(14.83,42.73),P＜0.001],and the method did not increase the incidence of adverse events[RR=0.83,95％CI(0.63,1.10),P=0.190],but the difference was not statistically significant in terms of healing time[MD=9.86,95％CI(-15.39,35.11),P=0.440].Conclusion Topical oxygen therapy helps to im-prove the response rate and reduce the ulcer size in patients with diabetic foot ulcers with a better safety profile,but the effect of the intervention on healing time is unclear.Further high-quality randomized controlled trials should be conducted in the future to validate the efficacy of topical oxygen therapy in patients with diabetic foot ulcers.

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A wound is a temporary break in the continuity of the protective skin barrier. Wound healing is central in maintaining the body's normal homeostatic mechanism, and open wounds raise the risk of microbial infection and amputation. A successful wound healing event is achieved through a series of evolutionarily conserved biochemical pathways orchestrated by various cytokines, growth factors, and immune cells. Chronic wounds are generally oxygen-deficient, and wound hypoxia impairs the wound healing process. Therefore, the use of external oxygen may improve wound health by reducing wound hypoxia, promoting tissue regeneration and granulation tissue formation, reducing anaerobic bacteria colonization, and promoting the growth of beneficial aerobic bacteria. Relevant data were searched and gathered from scientific databases, including PubMed, ScienceDirect, and Google Scholar using relevant keywords, such as "Chronic Wounds", "Topical Oxygen Therapy", "Inflammatory Markers/ Lactate/ Matrix Metalloproteinase", "Collagen", and "Wound Healing". Relevant articles were shortlisted and used in the present study. Chronic wounds show higher expression of pro-inflammatory mediators, such as C-reactive protein, and higher levels of tissue-degrading matrix metalloproteinases. In addition, chronic wounds are generally oxygen-deficient, and wound hypoxia is directly associated with wound deterioration. Several microbial, immunological, and biochemical markers show a direct association with the oxygen availability in the wound. Therefore, a detailed understanding of these microbial, immunological, and biochemical markers will certainly help clinicians understand the interplay between various factors and topical oxygen therapy and may improve patient outcomes.

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To evaluate the efficacy and safety of topical oxygen therapy (TOT) in diabetic foot ulcers (DFUs), researchers systematically retrieved relevant studies from PubMed, EMBASE, Web of Science, CENTRAL and ClinicalTrials.gov. Relevant studies were searched from database inception to January 2022. Two researchers independently screened the literature, extracted data and assessed the quality of the included studies. Statistical analysis was performed in Stata 16.0. A total of seven RCTs involving 614 participants were included. Compared with the control group, the TOT group had a higher healing rate (RR = 1.63, 95% CI [1.33, 2.00]). According to descriptive analysis, TOT reduced the ulcer area and improved healing durability and quality of life. Furthermore, it had no effect on the occurrence of adverse events. However, it was unclear whether it would be able to reduce the healing time. The existing evidence suggests that TOT is effective and safe for chronic DFUs. Further studies are warranted to validate our findings.

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The clinical and economic burden associated with hard-to-heal wounds is high and evidence suggests that it continues to increase. Healthcare resources consumed during the provision of wound care can be saved by implementing strategies and actions aimed at promoting wound healing. When these are successful, the frequency distribution curve for time to healing and for the consumption of healthcare resources should 'move to the left' and the extent to which it is 'skewed to the right' would be reduced, resulting in a reduction in the population mean for time to wound healing, and correspondingly, healthcare resources. Not only would this release healthcare resources in the short term, but, if these changes are maintained, would render savings sustainable, thereby contributing to lowering the overall burden of wounds and wound care. In this article, we present evidence that suggests that the adoption of adjunct topical haemoglobin spray can effect these desired changes in the wound healing curve and, due to the nature of the technology, it can be easily and sustainably implemented within relevant whole populations requiring wound care. The ease of adoption and impact is further illustrated by a patient case study.

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