Hand And Wrist: AntImicrobials and Infection – burieD vs. exposed K-wiRes In Fracture fixaTion

Broken bones in the hand and wrist are very common in the UK. They usually happen at work, following a fall or during sports. Sometimes, when these bones are broken, surgery will be needed to fix them. This is usually the case if the bones have broken and fallen out of place. Fixing broken bones in the hand and wrist is routinely performed in the National Health Service (NHS), accounting for about half of all surgeries for hand and wrist injuries.

During the surgery, the doctors will move the bones back into the right place and then use metal wires to hold them. These wires fix the bones in place while they heal. Once the bones have healed, the wires are then removed.

When the wires are put in, the ends of the wires can either stick out of the skin or be buried under the skin. There are no reliable studies that tell us if one option is better for patients. 

Both options have advantages and disadvantages. Wires buried under the skin might lower the risk of the hand or wrist becoming infected. This option is more expensive for the NHS and requires another surgery to remove the wire. Wires sticking out of the skin make them easy to remove and are cheaper for the NHS, however, patients might have a higher chance of getting an infection. This is important, as infections after surgery can be very serious. Infections can mean people need to come back into hospital for antibiotics and possibly further surgeries. It can also mean that their hands and wrists will recover slower, affecting work and daily life.

Summary

This is a study to compare the two options to work out which gives the best result. Participants with broken bones in the hand or wrist that need fixing with metal wires will be randomly chosen to have their wires buried or left sticking out. By choosing randomly, the two groups will be equal, except for whether the wire end is buried or left sticking out. The number of infections will be checked after 90 days and hand and wrist recovery will be checked at 6 months. The study will recruit 470 participants (235 in each of the two groups) with fractures of the hand or wrist. This study will be run in at least 22 hospitals around the UK, to make sure the results represent the whole country. Results from this study will help us decide how best to treat patients with broken hand and wrist bones that need surgery.

Background

Due to the central role of the hand and wrist in our everyday lives, injury through occupation, recreation, accidents and altercations is common. Hand and wrist trauma can have a substantial impact on an individual’s ability to look after themselves and earn a living. These injuries are increasing in the UK and across all healthcare settings globally. Fractures of the bones of the hand and wrist are the most common subtype of hand trauma, accounting for about 50% of all injuries. Although most do not need surgery, a proportion will be unstable and will require manipulation and fixation with metalwork to restore hand function. Recent UK studies indicate that over 50,000 hand and wrist fractures are operated on per year in the NHS. If a hand or wrist fracture requires fixation, then K-wires are usually employed to stabilise the bone following manipulation and reduction of the fracture. 

Once a fracture has been fixed with K-wires, the wires are routinely removed when the bone has healed. When the wires are placed, the ends of the wires may be cut short and buried beneath the skin, or the end of the wires can be left exposed outside of the skin. There is currently no reliable data to inform practice, nor any health economic data to inform national guidelines. Based on our national clinician survey, the key rationale for burying the end of the wire is the perceived reduction in risk of infection. The interface between an exposed wire and the skin is a site of potential Surgical Site Infection (SSI), commonly referred to as a ‘pin site infection’. Pin site infections are superficial SSIs that usually require treatment with antibiotics, with or without removal of the wire. A major concern is deep SSI, where the bone and/or joint becomes infected due to bacterial transport along the wire and into the bone in which it is placed. For patients, the consequences of SSI following hand and wrist trauma surgery include worse and prolonged pain, continued antibiotic prescription, re-operation, hospital admission, delayed rehabilitation and in severe cases, amputation of all or part of the affected hand. Acquiring an SSI doubles the length of hospital stay and leads to substantial additional direct healthcare costs.

Aims & Objectives

We aim to conduct a randomised controlled trial to evaluate the clinical and cost effectiveness of burying K-wires compared to leaving them exposed following fixation of adult hand or wrist fractures in terms of reducing SSI. We will compare the risk of SSI by 90 days post-randomisation between treatment groups.

Study Design

This is a multi-centre, two arm, parallel design, superiority, randomised controlled clinical study. The HAWAII-DRIFT study will recruit adults aged 16 or over with hand or wrist fractures that require fixation with K-wires. Eligibility will be assessed upon initial entry into the study, usually in the hand trauma or fracture clinic. After providing informed consent and baseline data, a second eligibility assessment will be performed immediately prior to surgery, in theatre, confirming eligibility at the point of randomisation. Participants will be fairly allocated (1:1) to either buried or exposed k-wires. The randomisation process will be stratified for: site, open/closed injury and anatomical location (hand/wrist). All participants will be followed up for six months. SSI will be the primary outcome at 90 days. Participants will also be asked about upper extremity function and pain, resource use, any complications, and their quality of life. Participant follow-up will be organised by the University of Oxford – either electronically by email, text message, paper or by telephone.

The recruitment period is approximately 15 months.