Back to resultsOmnibond vs Dermabond
Primary Purpose
Osteoarthritis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnibond Topical Skin Adhesive
Dermabond Advanced Topical Skin Adhesive
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
- 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
- Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion Criteria:
- 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
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
- Subjects who have participated in this trial previously and who were withdrawn
- Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
- Inability or refusal to provide informed consent or follow study and wound care instructions
Sites / Locations
- Columbia University
- JIS Orthopaedics
- Rothman Orthopaedic Institute
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Omnibond topical skin adhesive
Dermabond topical skin adhesive
Arm Description
Outcomes
Primary Outcome Measures
All time wound complications
any occurrence of a wound-related complication following surgery
Secondary Outcome Measures
Dry time
Time to dry (in seconds) between Omnibond vs Dermabond will be collected
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
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
Full Information
NCT ID
NCT05173519
First Posted
November 29, 2021
Last Updated
October 25, 2022
Sponsor
Center for Innovation and Research Organization
1. Study Identification
Unique Protocol Identification Number
NCT05173519
Brief Title
Omnibond vs Dermabond
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovation and Research Organization
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
310 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omnibond topical skin adhesive
Arm Type
Active Comparator
Arm Title
Dermabond topical skin adhesive
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Omnibond Topical Skin Adhesive
Intervention Description
Application of Omnibond topical skin adhesive to close incision following surgery
Intervention Type
Device
Intervention Name(s)
Dermabond Advanced Topical Skin Adhesive
Intervention Description
Application of Dermabond topical skin adhesive to close incision following surgery
Primary Outcome Measure Information:
Title
All time wound complications
Description
any occurrence of a wound-related complication following surgery
Time Frame
From surgery to 30 days post-op
Secondary Outcome Measure Information:
Title
Dry time
Description
Time to dry (in seconds) between Omnibond vs Dermabond will be collected
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
Title
User satisfaction with study treatment
Description
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
Time Frame
Up to 1 hour after study product application
Title
Subject satisfaction with study treatment
Description
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
Time Frame
Up to 14 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥18 years old
Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
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
Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion Criteria:
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
Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
Subjects who have participated in this trial previously and who were withdrawn
Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
Inability or refusal to provide informed consent or follow study and wound care instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Morrison, MS
Organizational Affiliation
Center for Innovation and Research Organization
Official's Role
Study Director
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
JIS Orthopaedics
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omnibond vs Dermabond
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