This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.
The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications. Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
310
Application of Omnibond topical skin adhesive to close incision following surgery
Application of Dermabond topical skin adhesive to close incision following surgery
Columbia University
New York, New York, United States
JIS Orthopaedics
New Albany, Ohio, United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
All time wound complications
any occurrence of a wound-related complication following surgery
Time frame: From surgery to 30 days post-op
Dry time
Time to dry (in seconds) between Omnibond vs Dermabond will be collected
Time frame: From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand
User satisfaction with study treatment
Visual Analog Scale (VAS) will be used to ask users how satisfied they were with the product. The scale minimum value is 0 and maximum value is 100. The higher the score, the higher the user satisfaction with the study product
Time frame: Up to 1 hour after study product application
Subject satisfaction with study treatment
Subjects will be asked at the time of first post-operative visit how satisfied they are with their study treatment using a Visual Analog Scale (VAS). The scale minimum value is 0 and maximum value is 100. The higher the score, the higher the patient satisfaction with the study product
Time frame: Up to 14 days following surgery
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