Omnibond vs Dermabond

• Sponsor: Center for Innovation and Research Organization (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05173519
• Collaborator: (none)
• Enrollment: 310
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 3
• Patients Per Site: 155
• Patients Per Site Per Month: 51.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: Omnibond Topical Skin Adhesive; Device: Dermabond Advanced Topical Skin Adhesive	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. All time wound complications [From surgery to 30 days post-op]

   any occurrence of a wound-related complication following surgery

Secondary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	JIS Orthopaedics	New Albany	Ohio	United States	43054
2	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Center for Innovation and Research Organization

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for Innovation and Research Organization
• ClinicalTrials.gov Identifier: NCT05173519
• Other Study ID Numbers: Omnibond001
• First Posted: Dec 30, 2021
• Last Update Posted: May 19, 2022
• Last Verified: Feb 1, 2022

• 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
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of May 19, 2022