The DRESSINg trial: A multicentre randomised controlled trial to assess the effectiveness of Dialkylcarbamoylchloride (DACC) coated post-operative dressings versus standard care in the prevention of Surgical Site Infection in clean or clean contaminated vascular surgery

Project Description

Aims
This study aims to investigate the role of a new dressing (DACC) in preventing wound infection follow vascular surgery. This dressing has a special coating that binds to bacteria irreversibly, allowing them to be removed. The DACC dressings will be compared to standard dressings (that simply cover the wound) that are usually applied after surgery.

Background
Surgery on arteries or veins (vascular surgery) is common, with over 200,000 operations in the UK every year. For every 100 patients undergoing vascular surgery, up to 40 may develop a wound infection, whereas in other types of surgery only 5 in every 100 patients would have infection. Often, patients needing vascular surgery are elderly, frail and have other conditions such as diabetes or cigarette smoking. These all increase their risk of problems after the operation. Every wound infection is distressing, causing pain, reduced mobility, extended hospital stays and scarring. Unfortunately, these patients are also at higher risk of losing limbs, and death. Studies show that DACC dressings are safe, suitable and acceptable to vascular surgical patients. These dressings may reduce the risk of infection, but that are more expensive than standard dressings. However, wound infections result in high financial cost to the NHS (over £6000 per infection) so a large scale research trial is needed to ensure DACC reduces wound infection without substantial cost to the NHS.

Methods
We have designed a study where 720 participants undergoing vascular surgery will be randomly allocated to receive either a DACC coated dressing or standard care. We will assess the impact of these dressings on rates of wound infection at 30 days. We will also record and compare the costs of the dressings and any extra treatment required for infection to determine whether the initial higher dressing cost is justified.

Patient Involvement
We have completed a feasibility study of 144 participants to assess our trial methods, as well as a focus group exercise. Our patients have helped us design this new study. Difficulty attending follow-up appointments was identified as a significant barrier to participation and was the leading reason for pulling out of the trial. We have now included the capacity to see patients in their own home where necessary and will also use the early phase of this trial to validate a digital remote method of detecting wound infection without patients needing to leave their own home. If shown to be accurate, this tool may be used in wider vascular follow-up services to reduce the need for physical attendance at appointments.

Expected Outcomes
We expect that this study will establish whether DACC dressings are effective at reducing wound infections after surgery. We will also understand if in doing so, these dressings are effective at reducing the cost of treating these patients. Additionally, through studies within this trial, we will find out if remote questionnaires, wound images or combinations of these are accurate at identifying wound infections.