None listed
Conditions
Brief summary
A Randomised control single centre trial for patients undergoing bilateral TKR for the treatment of osteoarthritis performed at the Mater Health Services North Queensland between December 2013 and June 2015. The trial is comprised of 2 phases, phase 1 focuses on the economics of Conventional Dry Dressings (CDD) for patients undergoing TKR. Phase 2 captures the cost of Negative Pressure Wound Therapy (NPWT) vs CDD as well as patient satisfaction in patients undergoing Bilateral TKR under three surgeons. Each knee shall be randomised to receive either dry dressings or negative pressure wound dressings. Surgeons and patients will be blinded to which leg will receive the CDD and the NPWT until wound closure and the dressings are to be applied. Patient satisfaction will be assessed in the form of a diary and questionnaire. Economy of dry dressing changes on the ward and in clinic is to be calculated with ward checklists. Data in regards to BMI, American Society of Anaesthesiologist Physical status classification, and Charlson Comorbidity Index will be collated as well. The follow up period is two weeks or untill the first outpatient review as per surgeons standard of care.
Interventions
There will be two phases to our study. Phase 1 will be purely observational to elucidate a baseline costing. The patients will be treated with the conventional dry dressings regularly utilised by the surgeons. This phase will last 2 months. Unilateral and bilateral total knee Arthroplasty patients will be recruited into this phase. ‘ Phase 2 will be a randomised controlled trial comparing patient satisfaction and cost between negative wound pressure therapy and conventional dry dressings. Patients undergoing bilateral knee arthroplasty will be recruited and have each knee randomised to either receiving NPWT or CDD. We expect this phase to last 8-12 months to recruit the required number of patients. The negative pressure dressing will be left intact till wound review between 10-12 days in outpatient clinic. Surgical wounds in these patients will be managed with negative pressure wound therapy (NPWT). Negative Pressure Wound Therapy (NPWT) has been used for many years for treatment of chronic wounds and more recently for post arthroplasty wound management. Orthopaedic surgeons are proactive in their consideration on surgical dressings in attempts to avoid costly post arthroplasty wound infections; at face value the closed, portable dressing system appears to provide an attractive option for wound care. NPWT consists of a closed, sealed system that applies negative pressure (suction) to the wound surface. The dressing is suggested to support primary intention to heal by improving local blood flow, facilitate oedema and exudate removal, reducing bacterial contamination, and promoting incision healing.The dressing will be applied by the surgeon at completion of surgery and left intact until the post-operative review appointment at 2 weeks post op. The patients will be discharged from hospital with a small canister attached to the dressing for collection of excess fluid.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients undergoing Total knee Arthroplasty for treatment of knee Arthritis, Male and non-pregnant females.
Exclusion criteria
Previous joint replacement. Known allergy to active ingredients in the drape adhesives used in dressings, both conventional dry dressings and Negative Pressure Wound Therapy devices.