Wound Infection Clinical Trial
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.
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02905955 -
Vacuumtherapy After Venous Hybrid Procedures
|
Phase 4 | |
Not yet recruiting |
NCT02868372 -
Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
|
N/A | |
Enrolling by invitation |
NCT02559453 -
Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds
|
N/A | |
Completed |
NCT02744144 -
Wound Bacterial Microbiota and Their Antibiotic Resistance
|
N/A | |
Active, not recruiting |
NCT01939145 -
Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
|
Phase 4 | |
Completed |
NCT00998907 -
PDS*Plus and Wound Infections After Laparotomy
|
N/A | |
Completed |
NCT01141335 -
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
|
Phase 4 | |
Completed |
NCT00576745 -
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
|
Phase 1 | |
Terminated |
NCT00654641 -
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
|
N/A | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Recruiting |
NCT00150852 -
Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
|
Phase 2 | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Active, not recruiting |
NCT04584957 -
Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)
|
N/A | |
Recruiting |
NCT03960970 -
Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
|
Phase 2 | |
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Completed |
NCT02018094 -
The Amputation Surgical Site Infection Trial (ASSIT)
|
Phase 4 | |
Terminated |
NCT03269968 -
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
|
N/A | |
Enrolling by invitation |
NCT02945761 -
High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
|
N/A | |
Not yet recruiting |
NCT02882360 -
Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum
|
Phase 4 |