Omnibond vs Dermabond

February 5, 2024 updated by: Center for Innovation and Research Organization

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • New Albany, Ohio, United States, 43054
        • JIS Orthopaedics
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omnibond topical skin adhesive
Device: Omnibond Topical Skin Adhesive
Application of Omnibond topical skin adhesive to close incision following surgery
Active Comparator: Dermabond topical skin adhesive
Device: Dermabond Advanced Topical Skin Adhesive
Application of Dermabond topical skin adhesive to close incision following surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All time wound complications
Time Frame: From surgery to 30 days post-op
any occurrence of a wound-related complication following surgery
From surgery to 30 days post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry time
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
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
User satisfaction with study treatment
Time Frame: 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
Up to 1 hour after study product application
Subject satisfaction with study treatment
Time Frame: 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
Up to 14 days following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Innovation and Research Organization

Investigators

  • Study Director: Tiffany Morrison, MS, Center for Innovation and Research Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omnibond001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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