A Prospective Single-blinded Randomized Controlled Study Evaluating Efficacy of Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 30
- Primary Endpoint
- Wound discharge during stay
Study Overview
Brief Summary
The study's primary objective is to compare the following parameters between wound closure following primary TKA with and without supplement tissue adhesive (Leukosan®):
Detailed Description
Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of Periprosthetic Joint Infection (PJI) 1-3. Several studies have highlighted this subject, and estimates of the risk of postoperative infection range from 1.3% to 50% among patients with persistent wound drainage 4. Such infections can be one of the most challenging complications following joint replacement surgery and is one of the leading causes of revision surgery following primary hip and knee arthroplasty 5,6.
Several patient-related factors have been associated with delayed wound healing and increased risk of infection following joint replacement surgery. Obesity 4,7, diabetes 8, smoking 9,10 and autoimmune disease 11 have been shown to have a detrimental effect on wound healing. Recently there has also been reports that patients with hypertension 12 have impaired wound healing following total hip arthroplasty (THA) and total knee arthroplasty (TKA).
Surgery related factors such as surgical approach, pneumatic tourniquet time and use of peri-articular local anesthesia have also been shown to have an effect on postoperative wound oozing 9,13.
Finally, several pharmacological factors, such as thromboembolic chemoprophylaxis 4, steroid treatment 9,14 and possibly statins 15,16 might also influence wound healing.
In recent years tissue adhesives for wound closure have been introduced as a replacement or a supplement to conventional closure techniques. Currently very few studies investigate the effect of such tissue adhesives in Total Knee Arthroplasty, and high quality randomized controlled trials (RCT) are lacking.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Investigator evaluating primary outcome is blinded to intervention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Regular
Regular closure:
The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure.
Additional tissue adhaesive
The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure. tissue adhesive (Leukosan®) is applied on top of the staples according to manufacturer instructions. One layer (one tube) of tissue adhesive is applied following air-drying for 30 seconds, followed by a placement of a second layer with a second layer (one tube), and a second air-drying period of 60 seconds
Intervention: tissue adhesive (Leukosan®) (Device)
Outcomes
Primary Outcomes
Wound discharge during stay
Time Frame: 3 days post op
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.
Secondary Outcomes
- ASEPSIS score(3 weeks post op)
Investigators
Kirill Gromov
MD, PhD, Ass. professor
Hvidovre University Hospital