DACC in the REduction of Surgical Site INfection

Launched by HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST · Dec 13, 2016

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of wound dressing, called Leukomed Sorbact, can help reduce the risk of infections after vascular surgery. Surgical site infections can happen in about 5% of surgeries, and in vascular surgeries, this rate can be as high as 30%. The dressing used in this trial is coated with a substance from spider silk that helps trap and remove bacteria from wounds when the dressing is changed. The researchers want to see if this dressing is more effective than a standard dressing that doesn’t have this coating.

To participate, you need to be an adult (18 years or older) who is having lower limb vascular surgery where the wound is closed directly. If you join the study, you will be randomly assigned to receive either the special dressing or the standard one, and your wound will be checked for infection 30 days after your surgery. You'll also fill out some questionnaires about your quality of life at 30 days and again at 3 months after surgery. Your choice to participate is completely voluntary, and it won’t affect your care or surgery in any way. This study will also explore the cost-effectiveness of the new dressing and its overall environmental impact.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible for inclusion in the study the participants must meet the following criteria:
• • Adults ≥18 yrs undergoing clean or clean-contaminated lower limb vascular surgery, with wounds closed by primary intention.
• • Able to understand the Patient Information Sheet and supplementary materials and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits and completing written questionnaires).
• Exclusion Criteria:
• Patients will not be included in the study if they meet any of the following exclusion criteria:
• • Patients on antibiotics for other conditions at the time of surgery or in the follow up period.
• • Patients undergoing any procedure that does not include lower limb incisions.
• • Allergies to any component of either the DACC-coated dressing or the control dressing.
• • Inability to give informed consent due to incapacity (as defined by the MCA 2005)
• • Aged under 18 years at the time of recruitment
• • Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study.