Topical application of haemoglobin: a safety study.

Area of Science:

• Wound Healing
• Biomedical Engineering
• Pharmacology

Background:

• Ischaemia significantly impedes wound healing by causing oxygen deprivation.
• Topical hemoglobin therapies offer a promising solution for chronic wounds, particularly in non-clinical settings.
• The use of pressurized spray devices for home application necessitates safety assessments regarding potential inhalation risks.

Purpose of the Study:

• To evaluate the particle size and concentration in the surrounding environment during topical hemoglobin spray application.
• To determine the potential risk of product particle inhalation by patients, users, and bystanders.
• To ensure the safety of a novel home-use wound healing therapy.

Main Methods:

• Particle size and concentration measurements were conducted using a laser scattered light photometer and a Scanning Mobility Particle Sizer (SMPS)-Spectrometer.
• Measurements were taken at various distances from the application site to assess inhalation exposure.
• Analysis included particle amount, size distribution, and potential dust formation.

Main Results:

• No nanoparticles or dust were generated during the application of the hemoglobin spray.
• Measured particle concentrations remained below the legally defined limits in Austria.
• The study found no evidence of harmful particle exposure during product use.

Conclusions:

• The topical hemoglobin spray is safe for home application, with no risk of inhaling nanoparticles or harmful concentrations of larger particles.
• All components of the hemoglobin spray are biodegradable and can be naturally excreted by the human body.
• This study supports the safe use of topical hemoglobin for wound healing in non-clinical environments.