Omnibond vs Dermabond | NCT05173519

Studies
Omnibond vs Dermabond

NCT05173519

Sponsor

Center for Innovation and Research Organization

Status

Suspended

Last Update Posted

Feb 7, 2024Actual

Enrollment

310Estimated

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Omnibond Topical Skin Adhesive
Dermabond Advanced Topical Skin Adhesive

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Temporarily halted

Expanded Access Info

Start Date

Oct 25, 2022Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Feb 2025Estimated

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Dec 10, 2021

First Posted Date

Dec 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omnibond topical skin adhesive	Active Comparator		Device: Omnibond Topical Skin Adhesive
Dermabond topical skin adhesive	Active Comparator		Device: Dermabond Advanced Topical Skin Adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omnibond Topical Skin Adhesive	Device	Application of Omnibond topical skin adhesive to close incision following surgery	Omnibond topical skin adhesive

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
User satisfaction with study treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University		New York	New York	10032	United States
JIS Orthopaedics

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases