Most surgical wounds are closed using stitches or staples, which allows them to heal directly.
However, in some cases, the wounds cannot be closed or may reopen after closure. These open surgical wounds are left to heal naturally from the inside out, which is known as ‘surgical wound healing by secondary intention’. These wounds are relatively common, can be incredibly difficult to heal and expensive to manage.
This healing process on average takes 3-6 months – but at 12 months 20% remain unhealed. Consequently, these wounds present significant physical and mental health challenges for patients.
There are multitude of dressings and treatments options for open surgical wounds. Yet surprisingly, these options lack scientific evidence of their effectiveness in practice and clinical guidance for application and usage. Decisions regarding their use are often based on tradition, anecdotal experience, or even sheer desperation rather than on sound research and established guidelines.
Professor Ian Chetter, Head of Vascular at Hull University Teaching Hospitals NHS Trust and Chair in Surgery at Hull York Medical School
Professor Ian Chetter, Head of Vascular at Hull University Teaching Hospitals NHS Trust and Chair in Surgery at Hull York Medical School
It was during a routine ward round almost 15 years ago that Professor Ian Chetter, Head of Vascular at Hull University Teaching Hospitals NHS Trust and Chair in Surgery at Hull York Medical School, found himself engaged in a conversation that could profoundly impact the management of these open wounds.
During this particular ward round, a registrar proposed the use of vacuum dressings or negative pressure wound therapy, for a patient’s wound.
This therapy involves applying a specialised vacuum dressing connected to a vacuum pump, that could – in theory – help promote wound healing and prevent infection. The registrar’s suggestion prompted Professor Chetter to question the lack of evidence supporting this approach.
This encounter sparked a curiosity that set him on a path to uncover the truth behind wound management using negative pressure wound therapy.
His aim is to gather solid scientific evidence which could inform clinical guidelines that will revolutionise the way open surgical wounds are treated, improving patient outcomes and overall wound management practices.
“Patients are desperate”
Surgical wounds that heal by secondary intention are a common, complex problem and are challenging to manage. A survey conducted in the UK found that the prevalence of these types of wounds was approximately 4.1 cases per 10,000 people. (1)
Motivated by the need for evidence-based wound care, Professor Chetter joined forces with a group of dedicated researchers led by Professor of Nursing Nicola Cullum and Professor of Applied Health Research Jo Dumville from the University of York. Together, they embarked on a journey to unravel the complexities of open surgical wounds.
Securing funding from the National Institute for Health Research (NIHR), they devised a comprehensive programme of research, including a cohort study, qualitative interviews with patients and clinicians, health economic analyses, and a pilot randomised controlled trial.
Their initial findings, published in the NIHR Journal Programme Grants for Applied Research revealed a higher incidence of open surgical wounds than previously estimated, with a diverse range of dressings being used without any scientific basis.
Through interviews with patients, Professor Chetter and his team gained invaluable insights into the profound physical, psychological, and social effects of chronic wounds. Patients described the associated symptoms such as pain, discharge, and odour, which standard quality of life assessments failed to capture.
Patients’ desperation for healing became apparent, as these wounds disrupted every aspect of their lives, affecting their relationships, mobility, and overall wellbeing.
The study revealed that patients would be receptive to new treatments, as they were incredibly eager to find a solution to their suffering.
Professor Chetter found the conversations with patients still resonated with him.
He said, “I vividly remember the conversations with patients – in particular one patient who said they couldn’t interact with their family or take their grandson to football.
"Patients’ lives are hugely affected by having an open wound. They are desperate for their wounds to be healed, yet there are no research-backed treatments to help them”
The research team also engaged with nurses and healthcare professionals who expressed their frustration at the lack of evidence-based guidelines for wound care.
The absence of clear directives made it challenging for them to reassure patients and confidently explain the benefits of certain dressings. Nurses, who were on the front lines of wound management, did not feel they had the tools to alleviate patients' pain and accelerate the healing process.
Conducting a nationwide trial
Empowered by their preliminary findings, Professor Chetter and his colleagues have been successful in receiving funding from the NIHR Health Technology Assessment (HTA) to conduct a nationwide large-scale randomised controlled trial (SWHSI-2).
Securing a £1.6 million grant, the trial was recruiting successfully – however, just as the trial was gaining momentum, the COVID-19 pandemic struck, leading to a six-month pause in recruitment. Undeterred, the team resumed recruitment and received an additional £400,000 from the HTA to extend the trial.
Despite the challenges posed by the pandemic, the study team successfully recruited their target of nearly 700 patients from 30 centres across England.
Central to the trial is the evaluation of negative wound pressure therapy versus standard care.
Professor Chetter said, “The theory behind negative pressure therapy suggests various reasons – including enhanced blood flow, improved bacterial clearance, and anti-inflammatory effects – could help to improve wound healing.
“The ultimate goal of the trial is to determine the clinical efficacy and cost-effectiveness of negative wound pressure therapy.”
The trial is being run collaboration with the University of York’s Trials Unit, who Professor Chetter acknowledges as being “a phenomenal resource.”
Acknowledging the pivotal role played by the York Clinical Trials Unit have in the trial, Professor Chetter said “Their expertise is incredible, and they are a powerhouse in clinical trials.
"Their support in facilitating recruitment to this large trial has proved invaluable, particularly in the face of staffing challenges in the NHS during the pandemic. The involvement of the York Trials Unit ensured the smooth operation and continuation of the trial.”
Catherine Arundel, Trial Manager at York Trials Unit, said of the study, “SWHSI-2 is, to our knowledge, the largest UK trial of negative wound pressure therapy as a treatment for patients with open surgical wounds.
"My colleagues and I at York Trials Unit have managed the design and delivery of the study, including setting up of sites, following up of patients and undertaking methodological work with the aim of improving trial recruitment and retention.
"York Trials Unit was a collaborator in Professor Chetter’s earlier work in this area, and so it has been excellent that we have been able to continue to work together to deliver a definitive trial in this area."
Future outlook
Professor Chetter and his team eagerly anticipate the analysis, publication, and presentation of their findings in 2024. Professor Chetter refers to this area of research as “his labour of love”, which has already ignited a research community across his trial sites in England dedicated to addressing the unmet needs of patients with chronic wounds.
Beyond the trial, new avenues of research are emerging at Hull York Medical School off the back of research in wound healing.
Dr Misha Sidapara, an NIHR Academic Clinical Fellow in Professor Chetter’s research group, is developing a core outcome set for surgical wound healing by secondary intention. Additionally, she aims to validate a disease-specific quality of life instrument specifically designed for open surgical wounds.
And in addition to this, Dr Bharat Ravindhran – also an NIHR Academic Clinical Fellow – recently presented a systematic review on this topic at the Society of Vascular Surgery in in Washington, DC, a significant international meeting attended by approximately 4,000 vascular surgeons and clinicians from around the world.
The gaps in wound research are becoming increasingly apparent, highlighting the urgent need for continued exploration and innovation to improve the lives of countless individuals affected by surgical wounds.
Professor Chetter's unwavering commitment to evidence-based practice, supported by a passionate team and collaborative partnerships, lays the foundation for a future where wounds are no longer a source of suffering but rather an opportunity for healing and restoration.
The SWHSI and SWHSI-2 projects have been funded by the National Institute for Health Research Programme Grants for Applied Health Research (RP-PG 0609 10171) AND Health Technology Assessment Programme (project number 17/42/94) respectively. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
For more information about this study, contact Professor Ian Chetter, Academic Lead for vascular research in the Clinical Sciences Centre at Hull York Medical School.
References
(1) Chetter IC, Oswald AV, Fletcher M, Dumville JC, Cullum NA. A survey of patients with surgical wounds healing bysecondary intention; an assessment of prevalence, aetiology, duration and management. J Tissue Viability. 2017;26:103–7. [PMC free article] [PubMed]