Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty

NCT03289247 | Completed

• 1 other identifier: HVH-SBTKA-Adhaesive
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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®):

Conditions

Total Knee Arthroplasty; Infection; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ASEPSIS score

  3 weeks post op

Study Arms (2)

Regular

NO INTERVENTION

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

EXPERIMENTAL

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

Device: tissue adhesive (Leukosan®)

Interventions

tissue adhesive (Leukosan®) DEVICE

Tissue ahaesive

Additional tissue adhaesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

MeSH Terms

Conditions

Infections

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator evaluating primary outcome is blinded to intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass. professor

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: September 1, 2015
• Primary Completion: December 21, 2017
• Study Completion: December 31, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01