Shifting the distribution curve for healthcare resource use through topical oxygen therapy for wound healing.

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.

Cost-effectiveness of adjunct haemoglobin spray in the treatment of hard-to-heal wounds in a UK NHS primary care setting.

OBJECTIVE: To evaluate the cost-effectiveness of topical haemoglobin spray as adjunct therapy in the treatment of hard-to-heal wounds within a UK National Health Service (NHS) community setting. METHOD: In a previously published comparative clinical evaluation, 50 consecutive patients treated with topical haemoglobin spray, as adjunct to standard care and followed up over 26 weeks, were compared with 50 consecutive retrospective controls from the same clinic treated with the same standard care protocol in the year prior to the introduction of adjunct topical haemoglobin spray. A de novo cost-effectiveness and break-even analysis were performed, using data from the previously published clinical evaluation, for all patients (intent-to-treat) and for patients with complete follow-up using a micro-costing approach and considering only wound care dressing costs. RESULTS: At 26 weeks, the total cost of dressings for all patients in the intervention group was £6953 with 874 cumulative weeks healed, compared with £9547 with 278 cumulative weeks healed for all patients in the control group. The incremental cost-effectiveness ratio (ICER), the incremental cost per additional week healed with adjunct topical haemoglobin spray, is therefore negative (dominant). Total treatment costs per week were lower from week six onwards, with break-even estimated to be at week 10.2. When considering only patients with complete follow-up, the results were similarly dominant, with a mean 10.9 more weeks healed, a mean dressing cost saving per patient of £81.83 by week 26 (-37%). Cost savings were realised from week five, and a break-even was estimated to occur at week 8.0. CONCLUSION: Topical haemoglobin spray has the potential to restore the healing process, reduce healing times and reduce dressing costs in a NHS community setting, within a few weeks of adoption.

Cost-effectiveness of soluble beta-glucan gel in hard-to-heal wounds: an evaluation.

OBJECTIVE: To evaluate the cost-effectiveness of a soluble beta-glucan-containing gel as short-term adjunct therapy in the treatment of hard-to-heal wounds in a UK community health-care setting. METHODS: A comparative clinical evaluation involving consecutive patients treated for up to eight weeks with a beta-glucan-containing gel as adjunct to standard care. This was compared with consecutive patients as retrospective controls, and using the same standard care protocol from a year previously. The inclusion criteria was wounds that were slow-healing or stalled (<40% healing in four weeks). RESULTS: A total of 300 patients took part. Complete follow-up at 24 weeks was available for 144 patients in the beta-glucan group, and 136 patients in the standard care group. At 24 weeks, the beta-glucan group had a 96% healing rate compared with 75% in the standard care group (p<0.001). The improvement in healing was associated with a reduction in the mean number of weeks of treatment per patient (7.2 and 10.7 for beta-glucan and standard care, respectively), and a reduction in the mean cost of treatment (£576 versus £685 for beta-glucan and standard care, respectively). Treatment costs included nursing time, prescription medications and dressings. In a subset of ulcer wounds (50% of the full sample), at 24 weeks the beta-glucan group had a 92% healing rate compared with 46% in the standard care group (p<0.001). Mean weeks of treatment were 10.4 versus 17.6, leading to a reduction in treatment cost of £388 per patient (£1227 versus £839) over 24 weeks. CONCLUSION: The results of this evaluation suggest that short-term use of the beta-glucan gel as an adjunct to standard care on slow-healing wounds can shorten healing times and reduce NHS costs.

Assessment of clinical effectiveness of haemoglobin spray as adjunctive therapy in the treatment of sloughy wounds.

OBJECTIVE: To assess use of an adjunctive topical haemoglobin spray in the treatment of sloughy wounds. METHOD: In addition to a standard wound care regimen, consecutive patients with sloughy wounds self-administered haemoglobin spray treatment twice a week until the wound was healed. All patients were followed-up for 26 weeks. Results were compared with a retrospective cohort of 100 consecutive patients, treated during the same period the previous year with standard wound care alone. Data were collected on wound characteristics including percentage of slough, exudate levels, wound pain, and wound size. RESULTS: After 26 weeks, 94/100 patients (94%) treated with haemoglobin spray were completely healed compared with 63/100 control patients (63%). Positive results were evident as early as week one with 52% mean wound size reduction using the heamoglobin spray versus 11% in the retrospective control (p<0.001). At baseline, mean slough coverage was higher in the haemoglobin group, 58% versus 44% in the control group (p<0.001). By week four, mean slough coverage was 1% in the haemoglobin versus 29% in the control group (p<0.001). Reductions in exudate and pain levels (p<0.001) were also observed. CONCLUSION: Overall, results of this evaluation showed the addition of adjunctive haemoglobin spray to standard wound care treatment achieved positive clinical outcomes for patients self-managing complicated sloughy wounds, by supporting reduction of wound exudate and slough within the complex multifaceted process of wound healing.

Hemoglobin spray as adjunct therapy in complex wounds: Meta-analysis versus standard care alone in pooled data by wound type across three retrospective cohort controlled evaluations.

OBJECTIVES: Low tissue oxygenation is a predictor of healing outcomes in complex wounds. Adjunct hemoglobin to aid oxygen diffusion has been demonstrated to achieve superior healing outcomes; however, the relative healing benefit across different wound types and evaluations has not yet been estimated. This article does this for the first time. METHODS: Data were pooled from previously published real world controlled evaluations, three retrospective cohort controlled studies of a variety of wounds within standard care across hospital and primary care in the North of England in patients with diabetic foot ulcers (n = 40), chronic wounds (n = 100), and sloughy wounds (n = 200). Wounds were equally distributed between adjunct hemoglobin and control and the hemoglobin spray was used as per instructions for use and applied twice weekly, mostly for the duration of the wounds in all three evaluations. Wound healing over 26 weeks was the primary outcome in each of the evaluations, with additional healing and quality of life indicators including pain, wound size, slough coverage, wound exudate levels, adverse events, and dressing regimen used, over time. Each wound type with 10 or more patients in both the standard care alone and adjunctive hemoglobin groups (n = 257/73% of patients) was evaluated. RESULTS: Cox proportional hazards log-rank regressions demonstrated significantly higher weekly chance of healing in each wound type (ß, 95% range, sample, p): trauma 1.55 (1.23-1.96, n = 110, p < 0.001), diabetic foot ulcers 2.39 (1.52-3.75, n = 60, p = 0.01), venous leg ulcers 4.98 (1.69-14.7, n = 33, p = 0.04), burns 1.82 (1.11-2.99, n = 30, p = 0.02), and post-surgical wounds 2.75 (1.53-4.96, n = 24, p = 0.001). Results on additional healing indicators were consistent with the main findings. Notably, controlling for ischemia in diabetic foot ulcers resulted in an increased ß of 5.68 (2.33-13.86, n = 29, p < 0.001). CONCLUSION: Adjunct hemoglobin spray, when implemented within standard care, is likely to achieve substantial healing benefits to patients, in particular for diabetic foot ulcers, venous leg ulcers, and post-surgical wounds.

Clinical effectiveness of hemoglobin spray (Granulox®) as adjunctive therapy in the treatment of chronic diabetic foot ulcers.

INTRODUCTION: Hemoglobin spray (Granulox®) comprises purified hemoglobin and is a novel approach for increasing oxygen availability in the wound bed in diabetic foot ulcer patients. Its mode of action is to bind oxygen from the atmosphere and diffuse it into the wound bed to accelerate wound healing in slow-healing wounds. PATIENTS AND METHODS: Wound healing outcomes, that is, wound size, pain, percentage of slough, and exudate levels, were compared retrospectively to a similar cohort of patients treated over the same period the previous year. The same inclusion and exclusion criteria applied to both groups. RESULTS: All 20 (100%) hemoglobin spray-treated patients and 15 (75%) control patients experienced some wound healing by week 4, with 5 (25%) and 1 (5%), respectively, achieving complete wound closure. At week 4, mean wound size reduction was 63% in the hemoglobin spray group versus 26% for controls, increasing to 95% reduction at week 28 in the hemoglobin spray group versus 63% for controls (p<0.05 at all timepoints). Hemoglobin spray was associated with substantially lower pain scores using a 10-cm visual analogue scale, with 19/19 patients (100%) being pain-free from week 12 onwards, compared to 6/18 patients (33%) in the control group. At week 28, 2/18 patients (11%) in the control group still had pain. Both groups had similar baseline slough levels, but hemoglobin spray-treated wounds had slough completely eliminated after 4 weeks versus 10% mean reduction in the control group (p<0.001). Hemoglobin spray was associated with markedly reduced exudate levels; within 4 weeks, no patients had high exudate levels in the hemoglobin spray group versus 5 in the control group. CONCLUSION: Standard wound care plus hemoglobin spray results in improvements in wound closure, wound size reduction, pain, slough, and exudate levels compared to control patients for chronic diabetic foot ulcer treatment.