Omnibond vs Dermabond

Osteoarthritis Clinical Trial

Official title:

A Prospective, Randomized, Single-blinded Study to Assess the Incidence of Wound Complications Following Total Knee and Hip Arthroplasty in Patients Treated With Two Different Types of Topical Skin Adhesive

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05173519
• Other study ID #: Omnibond001
• Status: Suspended
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Center for Innovation and Research Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 310
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Omnibond Topical Skin Adhesive
Application of Omnibond topical skin adhesive to close incision following surgery
• Dermabond Advanced Topical Skin Adhesive
Application of Dermabond topical skin adhesive to close incision following surgery

Locations

Country	Name	City	State
United States	JIS Orthopaedics	New Albany	Ohio
United States	Columbia University	New York	New York
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovation and Research Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All time wound complications	any occurrence of a wound-related complication following surgery	From surgery to 30 days post-op
Secondary	Dry time	Time to dry (in seconds) between Omnibond vs Dermabond will be collected	From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand
Secondary	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	Up to 1 hour after study product application
Secondary	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	Up to 14 days following surgery