Title: Safety and efficacy of a novel anti-microbial burn wound dressing
Funder: Department of Health and Social Care

Abstract: Post-burn infection is a major cause of sepsis, a condition that is responsible for approximately 11 million deaths worldwide per year. In order to limit the chances of burn sepsis following injury, wounds are thoroughly cleaned and antimicrobial dressings applied. The majority of these dressings contain silver that elutes into the wound-bed, imparting an antimicrobial effect. These dressings are typically expensive (ten times the cost of a standard dressing), making them unaffordable in low- and middle-income countries, and the use of silver can present a risk of the evolution of resistant bacterial species. Acetic acid-soaked gauze has been used worldwide to prevent infection for a long time, however, despite success the dressings must be changed at least daily, inflicting pain and potentially damaging the healing process, along with increased precious nursing care time. We have developed a dressing material that is capable of delivering a sustained dose of acetic acid into burn wounds (over three days). This dressing, designed following consultation with patient groups in a previously funded project, is transparent and non-adhesive. These characteristics mean that it is possible to leave the wound undisturbed for a longer period of time, by allowing inspection through the transparent material. The non-adhesive nature of the dressing reduces the typical painful dressing removal, causing less distress to the patient. Importantly, we have developed a facility and manufacturing processes that allow us to manufacture dressings within the Healthcare Technologies Institute at the University of Birmingham. The aim of this project will be to move this dressing technology forwards into a first-in-human safety trial with a secondary outcome of reduced infection. In parallel to this trial, acetic acid will be exposed to a range of microbes isolated from burn wounds in order to establish that acetic acid is unlikely to drive the evolution of new, resistant microbial species. We will also seek to refine our delivery technologies such that we can supply the acetic acid eluting materials in alternative ways such as spray and spreadable forms. The project is divided into 5 different work-packages: WP1 for manufacturing of the dressing; WP2 for microbiology evaluation; WP3 the randomized controlled trial in 20 patients; WP4 for the management of the project from manufacturing of the dressing through to delivery of the clinical trial, adhering to necessary regulatory approvals and monitoring of milestones; WP5 for patient and public involvement, whereby our PPI contributors have been involved from inception of the application and will be embedded throughout the life-cycle of the project. By the end of the project, the technology will be ready to be taken into phase II and III trials with the eventual goal of making the technology widely available in the NHS, and potentially through to partner hospitals in low- and middle-income countries. We believe that the use of the dressing technologies that will be developed and assessed during this project, have the potential to make antimicrobial dressings more effective and affordable, potentially contributing to a reduction in the world-wide occurrence wound infection and sepsis.

Lay abstract: Aims The aim of this project is to explore the effectiveness of a new type of dressing with acetic acid (vinegar) to keep burn wounds free of infection while they are healing. Background Infection after a burn injury is common and can have devastating consequences for patients and their families. Up to 42% of burn injury patients get an infection, which may progress to sepsis and up to 65% of sepsis patients do not survive. Infection happens because the top layer of the skin provides a barrier that prevents infection. When skin is burnt, this layer is destroyed, leaving patients at a higher risk of infection until it is fully healed. Current dressings Current dressings use products (e.g., silver) that can reduce the risk of infection but they are more expensive and have shown limited benefit. Another approach is to treat burn wounds with a cream or liquid that can reduce infection. Examples include a bleach-based product (Dakin) and a vinegar-based solution (acetic acid). These types of treatments applied directly to the wound are uncomfortable for burns patients, hurt when applied to the surface of the wound, have a strong and unpleasant odour and need to be replaced twice per day. Design and methods In this project, we will use a new approach developed at the University of Birmingham to apply a constant dose of acetic acid to a burn wound via a clear dressing. Our dressing can be used to kill germs for up to three days at a time, without the need for painful dressing changes twice a day. Participants in the study will have part of their wound treated with our dressing. The rest of the burn wound will receive the standard dressing. We will compare the two different areas for any infection, measure the healing, scar development and levels of pain. The participants and the medical team checking the wound for healing will not be told which area has been treated with acetic acid, so that they can judge both areas fairly. Patient and public involvement, engagement and dissemination This trial has been designed with our Patient and Public Co-applicants and our PPI group, consisting of patients with lived experience of burn injuries and scarring. The dressing itself has also been designed in collaboration with patients to make it the ideal treatment for burns. Importantly, it doesn t stick to the wound, is simple to remove, is see-through and can be stored easily. We will continue to work in partnership with our PPI Partners throughout the trial design, management, interpretation of results and how we share our findings with a wide range of audiences.

Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS;INFECTION