Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOmnibond Topical Skin Adhesive
Application of Omnibond topical skin adhesive to close incision following surgery
DEVICEDermabond Advanced Topical Skin Adhesive
Application of Dermabond topical skin adhesive to close incision following surgery
Sponsors
Center for Innovation and Research Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient ≥18 years old 2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females 3. Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty 4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information 5. Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion criteria
1. Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery 2. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception 3. Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene 4. Subjects who have participated in this trial previously and who were withdrawn 5. Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing. 6. Inability or refusal to provide informed consent or follow study and wound care instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All time wound complications | From surgery to 30 days post-op | any occurrence of a wound-related complication following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dry time | From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand | Time to dry (in seconds) between Omnibond vs Dermabond will be collected |
| User satisfaction with study treatment | Up to 1 hour after study product application | 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 |
| Subject satisfaction with study treatment | Up to 14 days following surgery | 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 |
Countries
United States
Outcome results
None listed