Ex-vivo Infection Detection (EVIDEnT)
Research type
Research Study
Full title
Laboratory observational Ex-Vivo study to investigate the sensitivity and specificity of a smart dressing to detect clinically relevant wound infection
IRAS ID
206022
Contact name
Amber Young
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Burn wound infections are difficult to diagnose. Diagnosis involves removing dressings, which may slow the healing process. A new dressing (Smartwound™) may help to diagnose infection without needing to remove dressings, and capsules within the dressing will change colour if the number of bacteria in the burn wound indicate that it is infected. Before it is used with patients, we need to check whether the capsules can identify when bacteria are, or are not, present in wounds. This study will use samples from patients with and without infected wounds to check whether the capsules change colour in the presence of bacteria that are causing a wound infection. The samples will come from burn wound fluid (exudate) taken from used wound dressings, and from swabs and gauze used during normal care of patients with burns.
Both adults and children with and without infected burn wounds, who attend one of four participating Burns Services will be asked to participate. Participants will be asked to consent to have their dressings kept by the study team once they have been removed during the course of their normal treatment, and for swab samples to be taken. From these a sample of exudate will be tested. Information will be recorded from participants’ notes about their health, care, suspected presence of infection and need for antibiotics. Participants will be followed-up within 21 days, either as part of normal scheduled clinic visits or by phone, and will be asked about their wound healing and health status.
The Smartwound dressing’s ability to detect infection will be measured using visual assessment of colour change. Bacteria from the swab will be tested separately to confirm presence of infection. Findings from this study will indicate whether capsules are effective in detection of infection prior to studies into the development of their use in dressings.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0238
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion