Topical haemoglobin spray is safe, efficacious, and cost-effective in the treatment of chronic wounds

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haemoglobinReviewing the evidence in the published literature for the use of topical haemoglobin spray in wound healing, Paul Chadwick proposes Granulox (Mölnlycke) is a safe, efficacious, and cost‑effective topical oxygen therapy for a range of chronic, hard‑to-heal wounds, and considers oxygen therapy “an often-overlooked component of wound management regimens”.

Oxygen is essential for wound healing processes, including angiogenesis, revascularisation, synthesis of connective tissue, and resistance to infection. The wound bed of a chronic, non‑healing wound is persistently hypoxic.1 Although hypoxia initially acts as a signal to stimulate wound healing, prolonged hypoxia is detrimental to healing.2, 3, 4 Topical oxygen therapy delivers oxygen directly to the wound tissue, thereby increasing oxygen levels at the wound site, reversing localised hypoxia and facilitating healing.2, 3, 4

Granulox is a topical haemoglobin spray that improves the oxygen supply to wounds on application by binding oxygen from the environment and transporting it to the wound bed where it diffuses into the cells, thereby promoting wound healing. Granulox is indicated for the treatment of chronic wounds, including venous, arterial, and mixed leg ulcers, diabetic foot ulcers and pressure ulcers, and the secondary healing of surgical, sloughy, and/or infected wounds.

A review of the literature from January 2010 to October 2020 identified 39 articles from peer‑reviewed journals and nine conference presentations with specific reference to the use of Granulox in wound management.

In a systematic review from 2020, Jieman Hu (The First Hospital of Jilin University, Changchun, China; School of Nursing, Jilin University, Changchun, China) et al concluded that Granulox promoted the healing of several wound types (leg, pressure, and diabetic foot ulcers, burns, and surgical and traumatic wounds) and was particularly efficacious in chronic, non-healing wounds.5 Granulox was reported to eliminate slough (which is important as slough can negatively impact wound healing) and relieve pain, and its ease of use supported patient self‑management, thus reducing healthcare costs.5

In 2018, a meta-analysis by Fredrik Elg (Pracipio Ltd, London, UK) and Sharon Hunt (Wellway Medical Group, Northumberland, UK) showed that Granulox plus standard wound care was likely to achieve substantial healing benefits in patients compared with standard wound care alone, with a higher weekly chance of healing in diabetic foot ulcers (p=0.01), venous leg ulcers (p=0.04), trauma (p<0.001), burns (p=0.02), and post‑surgical wounds (p=0.001).6

Five years earlier, in 2013, a randomised controlled trial was conducted to compare Granulox plus standard wound care with standard wound care alone in the treatment of chronic venous leg ulcers.7, 8 There was a mean 53% reduction in wound size (p<0.0001) after 13 weeks of treatment with standard wound care and additional Granulox compared with an enlargement of 21.3% in wound size with standard wound care alone over the same period.

Consistent with the above findings, interventional clinical studies showed the effectiveness of adding Granulox to standard wound care in the treatment of sloughy,9 chronic,10, 11 or hard‑to‑heal12 wounds, with significant reductions in wound size reported with additional Granulox in all four studies (p<0.001 as early as week one and at all timepoints up to week 24; p=0.002 at week 26;9 p=0.03 at week four; p=0.01 at week 16; p=0.02 at week 28;10, 11 p<0.001 at weeks one, four, eight, and 12; not significant at week 26).12

Elg and Bothma showed, in 2019, the cost‑effectiveness of adding Granulox to standard wound care for hard‑to-heal wounds, with dressing costs and cumulative weeks healed of £9,547 and £278, respectively, for standard wound care alone and £6,953 and £874, respectively, with added Granulox.12, 13 Similarly, Bernd Brüggenjürgen (Institut für Gesundheitsökonomie, Steinbeis-Hochschule-Berlin GmbH, Berlin, Germany) et al indicated a potential 40% reduction in overall wound care costs when Granulox was included in the treatment regimen for diabetic foot ulcers.11, 14

Results from observational clinical studies,15–26 case studies and case study series,27–42 and review articles2–4, 43–46 confirm the positive effects of Granulox on wound healing (wound size reduction or closure; reduction in slough, wound exudate, and pain; increase in local oxygen saturation at the wound site) when added to standard wound care for a variety of chronic wound types (leg, pressure, and diabetic foot ulcers, burns, and surgical and traumatic wounds), particularly in those wounds that were non‑healing or worsening. Granulox was reported to be an easy‑to‑use product, which helps patients engage with their healthcare needs and reduces healthcare costs, with treatment initiation recommended to be after four weeks of standard wound care if the wound was not healing.2, 44 The inclusion of Granulox into the treatment regimen was also reported to help avoid amputation surgery28, 32 and to improve patient quality of life. In addition, acceptability, lack of side effects, and cost‑effectiveness of Granulox were indicated.3, 43, 45 Furthermore, Granulox spray was considered to pose no danger from inhalation as no nanoparticles or dust were created during its application in a preclinical study.47

To me, the evidence in the literature therefore indicates Granulox is a safe, efficacious, easy‑to‑use, and cost‑effective adjunctive therapy to standard wound care for a range of chronic, non‑healing wounds, including leg, pressure, and diabetic foot ulcers, burns, and surgical and traumatic wounds.

Paul Chadwick

Paul Chadwick is the honourary consultant podiatrist and a visiting professor in Tissue Viability at Birmingham City University, Birmingham, UK.

Disclosures: Chadwick sits on an educational advisory panel for MHC but did not receive any payment for this piece.

References

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