NCT05173519

Omnibond vs Dermabond

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Center for Innovation and Research Organization · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Omnibond Topical Skin Adhesive	Application of Omnibond topical skin adhesive to close incision following surgery
DEVICE	Dermabond Advanced Topical Skin Adhesive	Application of Dermabond topical skin adhesive to close incision following surgery

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2021-12-30
• Last updated: 2024-02-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study