DACC in the REduction of Surgical Site INfection

Wound Infection Clinical Trial

— DRESSINg  

Official title:

A Randomised Controlled Trial to Assess the Clinical and Cost 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992951
• Other study ID #: R2034
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: Ross Lathan, MBChB
• Phone: 01482674643
• Email: ross.lathan2[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical site infection is an infection at a place in the body where surgery has taken place, and has been reported in around 5% of people undergoing an operation. In vascular surgery, infection rates are as high as 30%. Methods to reduce this rate of infection should be investigated thoroughly for their effectiveness and cost-effectiveness.

The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts with, and binds bacteria, causing them to be mechanically removed from a wound when the dressing is changed. The trial aims to compare the effectiveness of this dressing to a standard, non-coated dressing, in the reduction of surgical site infection.

718 patients from a number of centres across the UK will be recruited to this study. Adult patients who are having a vascular surgery operation will be approached for entry into the trial. The trial will be explained to them, as well as an explanation that participation is voluntary and their operation or other aspects of their care will not be impacted in any way should participants not wish to participate.

Participants will be randomised by computer into one of two groups - one group whose wounds are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard dressing. Patients will be followed up at 30 days post-operatively. At the follow up, their wounds will be inspected for infection, and participants will be asked to complete short questionnaires measuring quality of life. Quality of life will also be assessed at 3 months post surgery.

The trial will aim to answer a number of questions, with the primary question being does a DACC coated dressing applied after an operation reduce the risk of an infection at the surgery site? It will also ask whether this treatment is cost-effective and whether it promotes satisfactory healing and evaluate the overall carbon footprint impact of each intervention.

Studies Within a Trial will be conducted to validate a remote diagnostic measure for detecting surgical site infection using wound images and the Bluebelle Wound Healing Questionnaire, evaluate feasibility of novel hair removal methods such as epilation and waxing, carbon footprint modelling within randomised controlled trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 718
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infections
• Surgical Incision
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wound Infection, Surgical
• Wounds and Injuries

Intervention

Device:
• DACC-Coated Post Operative Dressing
Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.

Locations

Country	Name	City	State
United Kingdom	Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary	Hull	East Riding Of Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing 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 (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SWAT 1 Validation Acceptability	Response rates to measure at 30 and 37 days	30 and 37 days
Other	SWAT 1 Validation reliability	Inter and intra rater reliability	30 and 37 days
Other	SWAT 1 Validation Validity	Sensitivity, specificity, ROC analysis, AUC	30 days
Other	SWAT 2 Hair Removal Feasibility	Safety/adverse events	30 days
Other	Carbon Footprint Model Development	Healthcare resource use data, consumable item weights	3 months
Primary	30 day infection rate	Surgical Site Infection at 30 days post-op	30 days
Secondary	3 month infection rate	Surgical Site Infection at 3 months post-op (implant patients only)	3 months
Secondary	Quality of Life (SF-36 V2)	Score ranging from 0-100, higher values indicating better health	30 days, 3 months
Secondary	Quality of Life (EQ-5D-3L)	Score ranging from 5-15, higher scores indicating worse health	30 days, 3 months
Secondary	Mortality	30-day mortality	30 days
Secondary	Bluebelle wound healing questionnaire	Score ranging 0-41, higher values indicating infection	Days 30 and 37
Secondary	Carbon Footprint Analysis	Healthcare resource use data	3 months

External Links

•   Abstract Link