Omnibond vs Dermabond

Not Applicable

Suspended

• Conditions: Osteoarthritis
• Interventions: Device: Dermabond Advanced Topical Skin Adhesive; Device: Omnibond Topical Skin Adhesive

• Registration Number: NCT05173519
• Lead Sponsor: Center for Innovation and Research Organization

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-30
• Study Start: 2022-10-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond topical skin adhesive	Dermabond Advanced Topical Skin Adhesive	-
Omnibond topical skin adhesive	Omnibond Topical Skin Adhesive	-

Primary Outcome Measures

Name	Time	Method
All time wound complications	From surgery to 30 days post-op	any occurrence of a wound-related complication following surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

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, United States