ASSIGN - A Surgical Site Infection Groin study
Research type
Research Study
Full title
A single arm open label non-controlled study reporting the Incidence of Surgical Site Infection (SSI) among patients with groin incision wounds post-arterial surgery where incision sites are dressed with a topical nitric oxide releasing dressing (EDX110)
IRAS ID
301894
Contact name
Chris Wood
Contact email
Sponsor organisation
Thirty Holdings Limited
Clinicaltrials.gov Identifier
301894, IRAS
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
A single arm open label non-controlled study reporting the incidence of surgical site infections (SSI) among patients with groin incision wounds post vascular surgery where wounds are dressed with a topical nitric oxide releasing dressing (EDX110).
Fifty patients will be included in the study.The incidence of SSI, and performance and tolerability of EDX110 will be reported on patients who have a post-operative groin incision following vascular surgery.
EDX110 will be applied to the groin incision post-surgery and can remain in place for 5-7 days but, may be changed more frequently at the discretion of the clinician. Treatment will continue until the wound is healed.
At each assessment EDX110 will be removed and the incision site assessed for clinical signs of SSI and signs of local skin reactions (LSRs). The 2021 Centres for Disease Control (CDC) and Prevention Criteria will be used to identify deep incisional or superficial incisional SSIs.
Upon confirmation of healing, EDX110 treatment will be discontinued. Healing will be determined by the treating clinician and verified by an independent assessor using a photograph of the healed incision site.
REC name
Wales REC 6
REC reference
21/WA/0331
Date of REC Opinion
22 Oct 2021
REC opinion
Favourable Opinion