Infection Clinical Trial
Official title:
A Prospective Single-blinded Randomized Controlled Study Evaluating Efficacy of Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty
Verified date | January 2019 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study's primary objective is to compare the following parameters between wound closure following primary TKA with and without supplement tissue adhesive (Leukosan®):
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria - Patient > 18 years of age. - Patients determined to be suitable for primary simultaneous bilateral TKA based on physical exam and medical history including the following: o Osteoarthritis (OA) - Patient is skeletally mature. - Patient is willing and able to provide written informed consent. - Participants must be able to speak and understand Danish - Patient is willing and able to cooperate in the required post-operative therapy. - Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. Exclusion criteria - Patients with previous open knee surgery on either knee (i.e., osteotomy, unicompartemental arthroplasty, osteosynthesis) - Patients with previous major trauma to either knee resulting in deformity og scarring. - Patients receiving treatment for DVT or PE postoperatively. - Patients with known allergy to skin adhesives |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound discharge during stay | The wound will be defined as actively oozing, if the standard bandage Mepilex Border Post-op®, is soaked to the border. Bandages soaked to the border will be replaced. Number of replaced bandages for each knee will be recorded. | 3 days post op | |
Secondary | ASEPSIS score | Wound healing score | 3 weeks post op |
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