Information for Trial Participants

 This page provides background information about surgical site infection and wound guards. The FAQ section will answer many questions about your participation in the study, and how this will affect your care before, during and after surgery. Further details are provided in the patient information sheet.
Any patients who have questions or concerns arising from their participation in the study which are not answered here should speak to the surgical team responsible for their care

Frequently Asked Questions...

Below are some of the frequently asked questions we have come across so far. These questions and others are answered more fully in the Patient Information Sheet

• What is the purpose of the ROSSINI study?

ROSSINI stands for ‘Reduction Of Surgical Site Infection using a Novel Intervention’. The overall aim is to see if using a wound edge protection guard (this is the ‘novel intervention’) will reduce the chance of developing a surgical site infection.

• What is a Surgical Site Infection? How common is it?

A surgical site infection (SSI) is an infection of the incision (cut) made by your surgeon through which the operation is performed. It is also commonly called a ‘wound infection’.

The chances of developing an infection vary according to many factors. Some of these are dependent on the individual patient, for example if you smoke or suffer from diabetes your chances of developing an SSI are increased. Other factors depend on the nature of the operation.

A rough estimate of the likelihood of a patient developing an SSI would be a 10% (one in ten) chance if the operation is a planned procedure, increasing to around a 33% (one in three) chance if the operation is an emergency.

• What would be the effects of developing an SSI?

The main problem patients experience if they develop an infection in their wound is that it takes longer to heal up fully. This may result in you staying longer in hospital and requiring further treatment such as antibiotics or even an operation.

• What is a Wound-Edge Protection Guard?

This is a specially designed guard which is fitted into the wound during the operation by your surgeon to protect the edges of the wound.

• What are the alternatives to using a Wound-Edge Protection Guard?

The normal way the operation is performed is to use no device at all. The vast majority of patients undergoing surgery in the UK (and overseas) do not have a wound guard used in their procedure.

• Are there any risks in using the wound guard?

No. The wound guard does not add any additional risk to your operation. It takes only a few seconds to put in place at the beginning and then remove at the end of your operation.

• Why are these wound guards not used routinely if there is a possibility they may help reduce infections?

We do not know for definite if the wound guards work. There have been some similar (although smaller) studies of the wound guards with encouraging results. However, the studies did not involve enough patients to allow us to recommend that the wound guard be used in all patients undergoing abdominal surgery.

 

Patient Information Sheet...

A Patient Information Sheet will be provided to all patients participating in the trial by the surgical team. All patients considering taking part will have the opportunity to read through the sheet and ask any further questions before consenting to their involvement in the trial.

Full Patient Information Sheet