Trial Status: Starting February 2022
The HAWAII Feasibility Study: A multi-centre randomised feasibility study to determine the key indicators of feasibility for a definitive trial of antimicrobial sutures versus standard sutures in hand and wrist trauma surgery in adults aged 18 years old and over.
Hand and wrist injuries, also known as hand and wrist 'trauma', account for 1 in 5 emergency hospital visits. Every year, over 5 million people in the UK are affected, from young working people to the elderly. The hand and wrist are important in daily life and for earning a living. Many injuries need surgery and there is a risk of infection afterwards. The risk is unknown, but it might be as high as 1 in 4 people. Also, little is known about the knock-on effects of infection, which might be severe, including amputation. At the end of surgery for these injuries, the skin is closed using stitches. Specially coated stitches, known as 'antimicrobial stitches', might reduce infection in the wound by killing nearby bacteria. Preventing infection after surgery could improve recovery, regaining hand and wrist function sooner, and could reduce NHS costs. We want to test the usefulness of these antimicrobial stitches with a clinical trial in the NHS.
This small-scale study will look at antimicrobial stitches and infection. In this study, consenting participants with hand and wrist injuries from three hospitals in England will be allocated, by chance, into two groups. One group will get antimicrobial stitches during their surgery and one group will get normal stitches. There will be no other differences between the two groups.
The purpose of this small-scale study is to test out the information we give to people and to see if people would be happy to take part. The practicalities of measuring infection after surgery will also be tested. The results will allow us to determine if we can conduct a larger study to see if the antimicrobial stitches do reduce infection in people having surgery for hand and wrist injuries.
Hand trauma, comprising injuries to both the hand and wrist, affects over 5 million people per year in the NHS and result in around 250,000 operations per year. These figures are both increasing with time; as the UK population grows, the number of injuries and operations also increase. Hand trauma comprises a significant emergency workload in the UK and in Europe demonstrated by several epidemiological studies from Holland, Denmark and Scotland. In these studies, ranging from 1985- 2007, hand trauma consistently accounted for over 1-in-4 injuries requiring an Emergency Department (ED) attendance and up to 1-in-5 of all-cause ED attendances. The high incidence of hand trauma results in substantial costs to the health service. One of these studies costed hand and wrist injuries at £460 million in 2007-2008, which was more than hip fractures (£335 million) and head injury (£223 million). Direct healthcare costs accounted for 44% of this figure, the remainder consisting of indirect productivity costs. These indirect costs demonstrate that the majority of injuries occur in the young, working, male population (24-64 years old, 57% male) and that they lead to considerable disability and loss of earnings.
A proportion of hand and wrist injuries require surgery with the procedure depending on whether the injury is open (involving an open wound), or closed (no wound). Over half of hand and wrist injuries are open injuries. Most open injuries require repair of the injured structures and then suturing (stitching) of the injured skin. For closed injuries, a surgical wound is made to access and repair the underlying structures, which is most commonly a fractured bone. The wound is then closed with sutures and a dressing and/or splint is applied. Hand trauma patients then embark on a process of rehabilitation to return them to normal function as soon as possible. Infection at the site of an operation is commonly known as a Surgical Site Infection (SSI) and is one of the most common health-care associated infections worldwide.6 The consequences of SSI following hand and wrist trauma surgery include increased antibiotic prescription, re-operation, hospital admission, delayed rehabilitation and in severe cases, loss of all or part of the affected limb. Already incapacitated by the injury, SSI can further postpone or prohibit return to work and independent living. The combined effects of SSI after surgery increase both the direct and indirect socioeconomic costs to the patient, the health and care services and the wider UK economy. The National Institute of Health and Care Excellence (NICE) report the UK incidence of SSI to be between 3-5% across all surgical procedures. There is no reliable or contemporary data to inform the risk of SSI in hand trauma. However, the literature reports risks ranging from 5-10% in bony injuries and 5-13% in soft tissue injuries and consistently higher than the NICE estimate. The severity of hand and wrist SSI ranges from superficial infections requiring further antibiotics, deep infections requiring re-operation, life-threatening sepsis, toxic shock syndrome and death.
It is widely accepted that colonisation of surgical suture material is a common contributing factor to the development of bacterial wound infection. Sutures coated in Triclosan, an antimicrobial agent, can reduce SSI in major abdominal and vascular surgery procedures by around 28% (meta-analysis of 21 RCTs). These 'antimicrobial sutures' are more expensive than standard sutures: approximately £10 more per suture pack (£14.80 vs £4.71). However, a recent economic evaluation of RCTs found antimicrobial sutures to be cost-effective in specific patient populations. In these RCTs, the study populations are undergoing major, invasive surgery to the abdomen (e.g. laparotomy) with long operative times, adjunctive courses of intravenous antibiotics and long inpatient hospital stays. These study populations are not comparable to hand and wrist trauma patients and so the results are not generalisable. If antimicrobial sutures are effective in reducing hand and wrist trauma SSI, they could facilitate timely and more complete return of hand and wrist function. This would directly benefit patients in terms of earlier return to work and independent living, reducing burden on the health service and economy. The first step in evaluating the effectiveness of antimicrobial sutures in hand trauma is a feasibility study. This will allow us to ascertain the feasibility of a large-scale definitive trial of this potentially beneficial intervention for hand trauma patients.
Aims and objectives
The aim of this multi-centre randomised feasibility study is to determine the key indicators of feasibility for a definitive trial of antimicrobial sutures versus standard sutures in hand and wrist trauma surgery.
To establish key feasibility parameters to inform a definitive trial of antimicrobial sutures versus standard sutures in hand and wrist trauma surgery:
- Number of eligible participants
- Number of participants that consent to be included in the study
- Number of eligible participants that are randomised to either the intervention or control
- Number of participants with completed outcome measures at the set time points:
- SSI recorded at 30 days
- SSI recorded at 90 days
- PROMs completed at 30days
- PROMs completed at 90 days
- PROMs completed at six months
- The number of participants that report a complication
Two-arm, parallel group design, randomised on a 1:1 ratio to either antimicrobial sutures or standard sutures within a pragmatic feasibility RCT.
The trial will recruit from three centres in England. The whole trial will be electronic, including all participant information, consent forms, clinical record forms (CRFs) and outcome measures.
- Adults (>18) undergoing hand and wrist trauma surgery requiring sutures
- Willing and able to provide informed consent
- Allergic to Triclosan (active coating in antimicrobial sutures)
- Infected wounds
- Wounds not amenable to skin closure with sutures
- Nailbed injuries
- Unable to complete study procedures, including the completion of an electronic patient questionnaire in English